Diabetes

Tirzepatide (Zepbound) is not in shortage for now, but the weight loss drug has remained inaccessible to people without insurance coverage who can’t afford to pay out of pocket. Now, its manufacturer, Eli Lilly, has introduced a new formulation it says will “significantly expand” the supply. But not all endocrinologists are enthusiastic.

As of August 27, LillyDirect made 2.5-mg and 5-mg single-dose vials of tirzepatide available to self-pay patients with an on-label electronic prescription. Lilly’s announcement said the single-dose vials “are priced at a 50% or greater discount compared to the list price of all other incretin (glucagon-like peptide 1 receptor agonists or GLP-1) medicines for obesity.”

For a 4-week supply of the weekly injections, the discount at LillyDirect translates to $399 for a 2.5-mg single-dose vial ($99.75 per vial) and $549 for the 5-mg dose ($137.25 per vial), which the company noted was “in line with the Zepbound savings program for noncovered individuals.” (The new direct single-dose prescriptions cannot be filled at community or retail pharmacies.)

“In a clinical study, the 5-mg maintenance dose helped patients achieve an average of 15% weight loss after 72 weeks of treatment and has been a powerful tool for millions of people with obesity looking to lose weight and keep it off,” according to the announcement.

The clinical study, which is not named or referenced in the announcement, is SURMOUNT-1, a Lilly spokesperson said in an interview. Yet, that study also found that patients achieved an average weight loss of 19.5% with 10-mg doses and 20.9% with 15-mg doses of tirzepatide. Furthermore, the percentage of participants achieving body weight reductions of ≥ 5% was 85% (5 mg), 89% (10 mg), and 91% (15 mg), showing the benefits of higher doses.

And there’s the rub.
 

‘Only Two Different Doses’

Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the University of Southern California, Los Angeles, said in an interview: “My concern is, they’re only providing two different doses, 2.5 mg and 5 mg. You get somebody on it, and then they still have to go back to the traditional pens. I’m very opposed to getting patients connected to a medication they can’t then continue to take.

“Now we have starter doses that are easy to come by,” she said. “But the problem isn’t starting. The problem for all of these patients is chronic continuation of the right dose of the drug, and out-of-pocket costs become exorbitantly higher when they have to self-purchase the pens for the higher doses.

“Yes, the 5-mg dose has benefits, but not the same as higher doses,” she continued. “I have nobody for whom 5 mg is the right dose. They have to take more, sometimes within a month or 2 of starting, in order to achieve the kind of weight loss they need.”

If their insurance doesn’t cover the drug, “what are they going to do to stay on 5 mg? Or pay a crapload of money to buy three of the 5-mg doses to reach a higher dose?”

Michael Weintraub, MD, clinical assistant professor in the Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism at New York University Grossman School of Medicine in New York City, said that, “for many, this lower monthly cost is attainable and is a significant advancement in increasing access. For others, however, an out-of-pocket monthly cost of $349-549 for a chronic medication is still unaffordable.”

And like Dr. Peters, he said, “some patients do not lose a clinically significant amount of weight with 2.5 mg or 5 mg and require higher doses. There is no way of prescribing a higher dose of Zepbound vials, so patients would have to resort to the higher-dose auto-injector pens that are still double the price.”

A Lilly spokesperson countered in a comment: “Offering Zepbound single-dose vials in higher dosage strengths could increase the potential for dose splitting, which is not contemplated by the FDA [Food and Drug Adminstration]–approved label and may pose patient safety risks.”

But Dr. Peters wondered: “Wouldn’t dose splitting of a known-to-be-pure compound be better than getting it at a compounding pharmacy that lacks purity/safety? The one message from all of this is that patients need to know what they’re getting into. They’re starting a drug that can help with weight loss, but they’re going to be on a sub-max dose. And a higher dose is going to be double the price.”

In addition, said Robert F. Kushner, MD, a professor at Northwestern University Feinberg School of Medicine in Chicago, Illinois, “for the lower-dose vials, instead of administering the drug with a self-auto-injection pen, patients will need to use a needle and syringe and draw up the dose from a vial. This will take a higher skill level and health literacy that may be challenging for some patients. Patients may need additional training on how to use this new formulation. That will take additional time and resources, such as a demonstration in the office or referral to video.”

The Lilly news release noted that “patients can also purchase ancillary supplies, like syringes and needles, and will have access to important patient-friendly instructional materials on correctly administering the medicine via needle and syringe.”
 

Protection From Compounders?

According to the Lilly spokesperson, the launch of Zepbound vials “furthers our commitment to helping patients avoid the risks associated with compounded products by providing patients another option for access to genuine Lilly medicine.”

Indeed, said Jaime Almandoz, MD, medical director of the Weight Wellness Program and associate professor of internal medicine at the University of Texas Southwestern Medical Center in Dallas, “The introduction of Zepbound/tirzepatide in single-dose vials should improve access to evidence-based obesity treatments, reducing potential risks associated with compounded additives and eliminating the need for patients to calculate correct medication doses,” which have led to accidental overdoses of compounded semaglutide.

Lilly’s spokesperson added: “We have taken multiple steps — including publishing an open letter and launching lilly.com/real-medicine — to warn the public about the risks posed by the proliferation of counterfeit, fake, unsafe, or untested knockoffs of Lilly’s genuine medicines.”

But whether these steps are strong enough to overcome the realities of cost and the need for affordable higher doses remains to be seen.

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said in a statement that the new version of Zepbound “is great news for patients. It’s a much more rational and care-focused response to the remarkable demand for their drug than the lawsuits and cease-and-desist letters Lilly has been raining down on compounding pharmacies.”

“For 20 months now,” he continued, “compounders have been a lifeline for many patients, filling prescriptions for compounded tirzepatide injection at a time when the FDA-approved drug has been in shortage. We’ll be eager to see whether Lilly’s direct-to-patient approach actually works.”

Dr. Almandoz affirmed: “Everyone wants to see improved access to evidence-based obesity care. It’s crucial to ensure patients receive the most appropriate interventions, whether it is lifestyle changes, medications, or bariatric surgery,” he said. “There are resources available, [including his recent paper], for nutrition and lifestyle modifications specifically for patients taking obesity medications, which can help clinicians guide their patients toward better health.”

Dr. Almandoz is a member of advisory boards and consults for: Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. Dr. Kushner is an adviser to Eli Lilly and Novo Nordisk. Dr. Peters and Dr. Weintraub declared no competing interests.

A version of this article appeared on Medscape.com.

Tirzepatide (Zepbound) is not in shortage for now, but the weight loss drug has remained inaccessible to people without insurance coverage who can’t afford to pay out of pocket. Now, its manufacturer, Eli Lilly, has introduced a new formulation it says will “significantly expand” the supply. But not all endocrinologists are enthusiastic.

As of August 27, LillyDirect made 2.5-mg and 5-mg single-dose vials of tirzepatide available to self-pay patients with an on-label electronic prescription. Lilly’s announcement said the single-dose vials “are priced at a 50% or greater discount compared to the list price of all other incretin (glucagon-like peptide 1 receptor agonists or GLP-1) medicines for obesity.”

For a 4-week supply of the weekly injections, the discount at LillyDirect translates to $399 for a 2.5-mg single-dose vial ($99.75 per vial) and $549 for the 5-mg dose ($137.25 per vial), which the company noted was “in line with the Zepbound savings program for noncovered individuals.” (The new direct single-dose prescriptions cannot be filled at community or retail pharmacies.)

“In a clinical study, the 5-mg maintenance dose helped patients achieve an average of 15% weight loss after 72 weeks of treatment and has been a powerful tool for millions of people with obesity looking to lose weight and keep it off,” according to the announcement.

The clinical study, which is not named or referenced in the announcement, is SURMOUNT-1, a Lilly spokesperson said in an interview. Yet, that study also found that patients achieved an average weight loss of 19.5% with 10-mg doses and 20.9% with 15-mg doses of tirzepatide. Furthermore, the percentage of participants achieving body weight reductions of ≥ 5% was 85% (5 mg), 89% (10 mg), and 91% (15 mg), showing the benefits of higher doses.

And there’s the rub.
 

‘Only Two Different Doses’

Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the University of Southern California, Los Angeles, said in an interview: “My concern is, they’re only providing two different doses, 2.5 mg and 5 mg. You get somebody on it, and then they still have to go back to the traditional pens. I’m very opposed to getting patients connected to a medication they can’t then continue to take.

“Now we have starter doses that are easy to come by,” she said. “But the problem isn’t starting. The problem for all of these patients is chronic continuation of the right dose of the drug, and out-of-pocket costs become exorbitantly higher when they have to self-purchase the pens for the higher doses.

“Yes, the 5-mg dose has benefits, but not the same as higher doses,” she continued. “I have nobody for whom 5 mg is the right dose. They have to take more, sometimes within a month or 2 of starting, in order to achieve the kind of weight loss they need.”

If their insurance doesn’t cover the drug, “what are they going to do to stay on 5 mg? Or pay a crapload of money to buy three of the 5-mg doses to reach a higher dose?”

Michael Weintraub, MD, clinical assistant professor in the Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism at New York University Grossman School of Medicine in New York City, said that, “for many, this lower monthly cost is attainable and is a significant advancement in increasing access. For others, however, an out-of-pocket monthly cost of $349-549 for a chronic medication is still unaffordable.”

And like Dr. Peters, he said, “some patients do not lose a clinically significant amount of weight with 2.5 mg or 5 mg and require higher doses. There is no way of prescribing a higher dose of Zepbound vials, so patients would have to resort to the higher-dose auto-injector pens that are still double the price.”

A Lilly spokesperson countered in a comment: “Offering Zepbound single-dose vials in higher dosage strengths could increase the potential for dose splitting, which is not contemplated by the FDA [Food and Drug Adminstration]–approved label and may pose patient safety risks.”

But Dr. Peters wondered: “Wouldn’t dose splitting of a known-to-be-pure compound be better than getting it at a compounding pharmacy that lacks purity/safety? The one message from all of this is that patients need to know what they’re getting into. They’re starting a drug that can help with weight loss, but they’re going to be on a sub-max dose. And a higher dose is going to be double the price.”

In addition, said Robert F. Kushner, MD, a professor at Northwestern University Feinberg School of Medicine in Chicago, Illinois, “for the lower-dose vials, instead of administering the drug with a self-auto-injection pen, patients will need to use a needle and syringe and draw up the dose from a vial. This will take a higher skill level and health literacy that may be challenging for some patients. Patients may need additional training on how to use this new formulation. That will take additional time and resources, such as a demonstration in the office or referral to video.”

The Lilly news release noted that “patients can also purchase ancillary supplies, like syringes and needles, and will have access to important patient-friendly instructional materials on correctly administering the medicine via needle and syringe.”
 

Protection From Compounders?

According to the Lilly spokesperson, the launch of Zepbound vials “furthers our commitment to helping patients avoid the risks associated with compounded products by providing patients another option for access to genuine Lilly medicine.”

Indeed, said Jaime Almandoz, MD, medical director of the Weight Wellness Program and associate professor of internal medicine at the University of Texas Southwestern Medical Center in Dallas, “The introduction of Zepbound/tirzepatide in single-dose vials should improve access to evidence-based obesity treatments, reducing potential risks associated with compounded additives and eliminating the need for patients to calculate correct medication doses,” which have led to accidental overdoses of compounded semaglutide.

Lilly’s spokesperson added: “We have taken multiple steps — including publishing an open letter and launching lilly.com/real-medicine — to warn the public about the risks posed by the proliferation of counterfeit, fake, unsafe, or untested knockoffs of Lilly’s genuine medicines.”

But whether these steps are strong enough to overcome the realities of cost and the need for affordable higher doses remains to be seen.

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said in a statement that the new version of Zepbound “is great news for patients. It’s a much more rational and care-focused response to the remarkable demand for their drug than the lawsuits and cease-and-desist letters Lilly has been raining down on compounding pharmacies.”

“For 20 months now,” he continued, “compounders have been a lifeline for many patients, filling prescriptions for compounded tirzepatide injection at a time when the FDA-approved drug has been in shortage. We’ll be eager to see whether Lilly’s direct-to-patient approach actually works.”

Dr. Almandoz affirmed: “Everyone wants to see improved access to evidence-based obesity care. It’s crucial to ensure patients receive the most appropriate interventions, whether it is lifestyle changes, medications, or bariatric surgery,” he said. “There are resources available, [including his recent paper], for nutrition and lifestyle modifications specifically for patients taking obesity medications, which can help clinicians guide their patients toward better health.”

Dr. Almandoz is a member of advisory boards and consults for: Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. Dr. Kushner is an adviser to Eli Lilly and Novo Nordisk. Dr. Peters and Dr. Weintraub declared no competing interests.

A version of this article appeared on Medscape.com.

Tirzepatide (Zepbound) is not in shortage for now, but the weight loss drug has remained inaccessible to people without insurance coverage who can’t afford to pay out of pocket. Now, its manufacturer, Eli Lilly, has introduced a new formulation it says will “significantly expand” the supply. But not all endocrinologists are enthusiastic.

As of August 27, LillyDirect made 2.5-mg and 5-mg single-dose vials of tirzepatide available to self-pay patients with an on-label electronic prescription. Lilly’s announcement said the single-dose vials “are priced at a 50% or greater discount compared to the list price of all other incretin (glucagon-like peptide 1 receptor agonists or GLP-1) medicines for obesity.”

For a 4-week supply of the weekly injections, the discount at LillyDirect translates to $399 for a 2.5-mg single-dose vial ($99.75 per vial) and $549 for the 5-mg dose ($137.25 per vial), which the company noted was “in line with the Zepbound savings program for noncovered individuals.” (The new direct single-dose prescriptions cannot be filled at community or retail pharmacies.)

“In a clinical study, the 5-mg maintenance dose helped patients achieve an average of 15% weight loss after 72 weeks of treatment and has been a powerful tool for millions of people with obesity looking to lose weight and keep it off,” according to the announcement.

The clinical study, which is not named or referenced in the announcement, is SURMOUNT-1, a Lilly spokesperson said in an interview. Yet, that study also found that patients achieved an average weight loss of 19.5% with 10-mg doses and 20.9% with 15-mg doses of tirzepatide. Furthermore, the percentage of participants achieving body weight reductions of ≥ 5% was 85% (5 mg), 89% (10 mg), and 91% (15 mg), showing the benefits of higher doses.

And there’s the rub.
 

‘Only Two Different Doses’

Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the University of Southern California, Los Angeles, said in an interview: “My concern is, they’re only providing two different doses, 2.5 mg and 5 mg. You get somebody on it, and then they still have to go back to the traditional pens. I’m very opposed to getting patients connected to a medication they can’t then continue to take.

“Now we have starter doses that are easy to come by,” she said. “But the problem isn’t starting. The problem for all of these patients is chronic continuation of the right dose of the drug, and out-of-pocket costs become exorbitantly higher when they have to self-purchase the pens for the higher doses.

“Yes, the 5-mg dose has benefits, but not the same as higher doses,” she continued. “I have nobody for whom 5 mg is the right dose. They have to take more, sometimes within a month or 2 of starting, in order to achieve the kind of weight loss they need.”

If their insurance doesn’t cover the drug, “what are they going to do to stay on 5 mg? Or pay a crapload of money to buy three of the 5-mg doses to reach a higher dose?”

Michael Weintraub, MD, clinical assistant professor in the Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism at New York University Grossman School of Medicine in New York City, said that, “for many, this lower monthly cost is attainable and is a significant advancement in increasing access. For others, however, an out-of-pocket monthly cost of $349-549 for a chronic medication is still unaffordable.”

And like Dr. Peters, he said, “some patients do not lose a clinically significant amount of weight with 2.5 mg or 5 mg and require higher doses. There is no way of prescribing a higher dose of Zepbound vials, so patients would have to resort to the higher-dose auto-injector pens that are still double the price.”

A Lilly spokesperson countered in a comment: “Offering Zepbound single-dose vials in higher dosage strengths could increase the potential for dose splitting, which is not contemplated by the FDA [Food and Drug Adminstration]–approved label and may pose patient safety risks.”

But Dr. Peters wondered: “Wouldn’t dose splitting of a known-to-be-pure compound be better than getting it at a compounding pharmacy that lacks purity/safety? The one message from all of this is that patients need to know what they’re getting into. They’re starting a drug that can help with weight loss, but they’re going to be on a sub-max dose. And a higher dose is going to be double the price.”

In addition, said Robert F. Kushner, MD, a professor at Northwestern University Feinberg School of Medicine in Chicago, Illinois, “for the lower-dose vials, instead of administering the drug with a self-auto-injection pen, patients will need to use a needle and syringe and draw up the dose from a vial. This will take a higher skill level and health literacy that may be challenging for some patients. Patients may need additional training on how to use this new formulation. That will take additional time and resources, such as a demonstration in the office or referral to video.”

The Lilly news release noted that “patients can also purchase ancillary supplies, like syringes and needles, and will have access to important patient-friendly instructional materials on correctly administering the medicine via needle and syringe.”
 

Protection From Compounders?

According to the Lilly spokesperson, the launch of Zepbound vials “furthers our commitment to helping patients avoid the risks associated with compounded products by providing patients another option for access to genuine Lilly medicine.”

Indeed, said Jaime Almandoz, MD, medical director of the Weight Wellness Program and associate professor of internal medicine at the University of Texas Southwestern Medical Center in Dallas, “The introduction of Zepbound/tirzepatide in single-dose vials should improve access to evidence-based obesity treatments, reducing potential risks associated with compounded additives and eliminating the need for patients to calculate correct medication doses,” which have led to accidental overdoses of compounded semaglutide.

Lilly’s spokesperson added: “We have taken multiple steps — including publishing an open letter and launching lilly.com/real-medicine — to warn the public about the risks posed by the proliferation of counterfeit, fake, unsafe, or untested knockoffs of Lilly’s genuine medicines.”

But whether these steps are strong enough to overcome the realities of cost and the need for affordable higher doses remains to be seen.

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said in a statement that the new version of Zepbound “is great news for patients. It’s a much more rational and care-focused response to the remarkable demand for their drug than the lawsuits and cease-and-desist letters Lilly has been raining down on compounding pharmacies.”

“For 20 months now,” he continued, “compounders have been a lifeline for many patients, filling prescriptions for compounded tirzepatide injection at a time when the FDA-approved drug has been in shortage. We’ll be eager to see whether Lilly’s direct-to-patient approach actually works.”

Dr. Almandoz affirmed: “Everyone wants to see improved access to evidence-based obesity care. It’s crucial to ensure patients receive the most appropriate interventions, whether it is lifestyle changes, medications, or bariatric surgery,” he said. “There are resources available, [including his recent paper], for nutrition and lifestyle modifications specifically for patients taking obesity medications, which can help clinicians guide their patients toward better health.”

Dr. Almandoz is a member of advisory boards and consults for: Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. Dr. Kushner is an adviser to Eli Lilly and Novo Nordisk. Dr. Peters and Dr. Weintraub declared no competing interests.

A version of this article appeared on Medscape.com.

In the setting of isocaloric eating, time-restricted eating (TRE) did not reduce weight or improve glucose homeostasis relative to a usual eating pattern (UEP), a small randomized controlled trial found.

The results suggested that any effects of TRE on weight observed in prior studies may be due to reductions in caloric intake and not timing, according to Nisa M. Maruthur, MD, MHS, of the Division of General Internal Medicine at the Johns Hopkins School of Medicine in Baltimore, and colleagues.

Published in Annals of Internal Medicine, the 12-week trial randomly assigned 41 adults aged 18-69 years with obesity and prediabetes or diet-controlled diabetes 1:1 as follows: To TRE, involving a 10-hour eating window with 80% of calories consumed before 1 PM, or to UEP, involving a ≤ 16-hour window, with at least 50% of calories consumed after 5 PM. The regimen in each group was based on the OmniHeart unsaturated fat diet and the SPICE study.

“The diet was similar to the DASH [Dietary Approaches to Stop Hypertension] diet for hypertension and maybe a bit higher in unsaturated fat and micronutrients,” said study co-author Scott J. Pilla, MD, MHS, an assistant professor of medicine at the Johns Hopkins Bloomberg School of Public Health, Baltimore, in an interview. For each participant, macro- and micronutrient content remained constant throughout the study period, with total calories individually determined at baseline and ranging from 1600 to 3500 kcal/d. “That differs from some TRE studies in which calories were adjusted according to whether participants lost or gained weight,” he said. “This was a purely mechanistic study to determine the impact of time of eating alone with no change in calories.”

The Cohort

The mean age was 59 years, 93% of patients were women, and 93% were Black. The mean body mass index was 36, and the mean baseline weight was 96.2 kg — 95.6 kg in the TRE group and 103.7 kg in the UEP group.

At 12 weeks, weight decreased comparably by 2.3 kg (95% CI, 1.0-3.5) in the TRE group and by 2.6 kg (95% CI, 1.5-3.7) in the UEP group. Change in glycemic measures did not differ between the two groups.

Interestingly, self-reporting questionnaires revealed a slight reduction in physical activity in the TRE group, an effect that requires further study. “We don’t know why but anecdotally, some TRE participants said they tended to go to bed earlier,” Dr. Pilla said. Earlier bedtimes may put an end sooner to the daily eating pattern.

Subanalyses of the data are ongoing and will be published later.

“In the context of several clinical trials that suggest a benefit of TRE, our findings suggest that if or when TRE interventions induce weight loss, it is likely in part due to a reduction in energy intake, and therefore, clinicians can counsel patients that TRE may help them lose weight by decreasing their caloric intake,” the authors wrote.

In an accompanying editorial, Krista A. Varady, PhD, and Vanessa M. Oddo, PhD, of the Department of Kinesiology and Nutrition at the University of Illinois–Chicago, said the study results have important clinical implications. “Many patients stop following standard-care diets (such as daily calorie restriction) because they become frustrated with having to monitor food intake vigilantly each day,” they wrote.

Gastroenterologists and Obesity

Of late, support has grown for gastroenterologists to become actively involved in obesity treatment — even to “take ownership” of this field.

In a 2023 article in Gut, Michael Camilleri, MD, AGAF, a gastroenterologist at the Mayo Clinic in Rochester, Minnesota, made the case for the natural fit between gastrointestinal (GI) specialists and obesity management. He noted that obesity is a significant risk factor for GI, pancreatic, and liver diseases. It can even affect inflammatory bowel disease.

A version of this article first appeared on Medscape.com.

In the setting of isocaloric eating, time-restricted eating (TRE) did not reduce weight or improve glucose homeostasis relative to a usual eating pattern (UEP), a small randomized controlled trial found.

The results suggested that any effects of TRE on weight observed in prior studies may be due to reductions in caloric intake and not timing, according to Nisa M. Maruthur, MD, MHS, of the Division of General Internal Medicine at the Johns Hopkins School of Medicine in Baltimore, and colleagues.

Published in Annals of Internal Medicine, the 12-week trial randomly assigned 41 adults aged 18-69 years with obesity and prediabetes or diet-controlled diabetes 1:1 as follows: To TRE, involving a 10-hour eating window with 80% of calories consumed before 1 PM, or to UEP, involving a ≤ 16-hour window, with at least 50% of calories consumed after 5 PM. The regimen in each group was based on the OmniHeart unsaturated fat diet and the SPICE study.

“The diet was similar to the DASH [Dietary Approaches to Stop Hypertension] diet for hypertension and maybe a bit higher in unsaturated fat and micronutrients,” said study co-author Scott J. Pilla, MD, MHS, an assistant professor of medicine at the Johns Hopkins Bloomberg School of Public Health, Baltimore, in an interview. For each participant, macro- and micronutrient content remained constant throughout the study period, with total calories individually determined at baseline and ranging from 1600 to 3500 kcal/d. “That differs from some TRE studies in which calories were adjusted according to whether participants lost or gained weight,” he said. “This was a purely mechanistic study to determine the impact of time of eating alone with no change in calories.”

The Cohort

The mean age was 59 years, 93% of patients were women, and 93% were Black. The mean body mass index was 36, and the mean baseline weight was 96.2 kg — 95.6 kg in the TRE group and 103.7 kg in the UEP group.

At 12 weeks, weight decreased comparably by 2.3 kg (95% CI, 1.0-3.5) in the TRE group and by 2.6 kg (95% CI, 1.5-3.7) in the UEP group. Change in glycemic measures did not differ between the two groups.

Interestingly, self-reporting questionnaires revealed a slight reduction in physical activity in the TRE group, an effect that requires further study. “We don’t know why but anecdotally, some TRE participants said they tended to go to bed earlier,” Dr. Pilla said. Earlier bedtimes may put an end sooner to the daily eating pattern.

Subanalyses of the data are ongoing and will be published later.

“In the context of several clinical trials that suggest a benefit of TRE, our findings suggest that if or when TRE interventions induce weight loss, it is likely in part due to a reduction in energy intake, and therefore, clinicians can counsel patients that TRE may help them lose weight by decreasing their caloric intake,” the authors wrote.

In an accompanying editorial, Krista A. Varady, PhD, and Vanessa M. Oddo, PhD, of the Department of Kinesiology and Nutrition at the University of Illinois–Chicago, said the study results have important clinical implications. “Many patients stop following standard-care diets (such as daily calorie restriction) because they become frustrated with having to monitor food intake vigilantly each day,” they wrote.

Gastroenterologists and Obesity

Of late, support has grown for gastroenterologists to become actively involved in obesity treatment — even to “take ownership” of this field.

In a 2023 article in Gut, Michael Camilleri, MD, AGAF, a gastroenterologist at the Mayo Clinic in Rochester, Minnesota, made the case for the natural fit between gastrointestinal (GI) specialists and obesity management. He noted that obesity is a significant risk factor for GI, pancreatic, and liver diseases. It can even affect inflammatory bowel disease.

A version of this article first appeared on Medscape.com.

In the setting of isocaloric eating, time-restricted eating (TRE) did not reduce weight or improve glucose homeostasis relative to a usual eating pattern (UEP), a small randomized controlled trial found.

The results suggested that any effects of TRE on weight observed in prior studies may be due to reductions in caloric intake and not timing, according to Nisa M. Maruthur, MD, MHS, of the Division of General Internal Medicine at the Johns Hopkins School of Medicine in Baltimore, and colleagues.

Published in Annals of Internal Medicine, the 12-week trial randomly assigned 41 adults aged 18-69 years with obesity and prediabetes or diet-controlled diabetes 1:1 as follows: To TRE, involving a 10-hour eating window with 80% of calories consumed before 1 PM, or to UEP, involving a ≤ 16-hour window, with at least 50% of calories consumed after 5 PM. The regimen in each group was based on the OmniHeart unsaturated fat diet and the SPICE study.

“The diet was similar to the DASH [Dietary Approaches to Stop Hypertension] diet for hypertension and maybe a bit higher in unsaturated fat and micronutrients,” said study co-author Scott J. Pilla, MD, MHS, an assistant professor of medicine at the Johns Hopkins Bloomberg School of Public Health, Baltimore, in an interview. For each participant, macro- and micronutrient content remained constant throughout the study period, with total calories individually determined at baseline and ranging from 1600 to 3500 kcal/d. “That differs from some TRE studies in which calories were adjusted according to whether participants lost or gained weight,” he said. “This was a purely mechanistic study to determine the impact of time of eating alone with no change in calories.”

The Cohort

The mean age was 59 years, 93% of patients were women, and 93% were Black. The mean body mass index was 36, and the mean baseline weight was 96.2 kg — 95.6 kg in the TRE group and 103.7 kg in the UEP group.

At 12 weeks, weight decreased comparably by 2.3 kg (95% CI, 1.0-3.5) in the TRE group and by 2.6 kg (95% CI, 1.5-3.7) in the UEP group. Change in glycemic measures did not differ between the two groups.

Interestingly, self-reporting questionnaires revealed a slight reduction in physical activity in the TRE group, an effect that requires further study. “We don’t know why but anecdotally, some TRE participants said they tended to go to bed earlier,” Dr. Pilla said. Earlier bedtimes may put an end sooner to the daily eating pattern.

Subanalyses of the data are ongoing and will be published later.

“In the context of several clinical trials that suggest a benefit of TRE, our findings suggest that if or when TRE interventions induce weight loss, it is likely in part due to a reduction in energy intake, and therefore, clinicians can counsel patients that TRE may help them lose weight by decreasing their caloric intake,” the authors wrote.

In an accompanying editorial, Krista A. Varady, PhD, and Vanessa M. Oddo, PhD, of the Department of Kinesiology and Nutrition at the University of Illinois–Chicago, said the study results have important clinical implications. “Many patients stop following standard-care diets (such as daily calorie restriction) because they become frustrated with having to monitor food intake vigilantly each day,” they wrote.

Gastroenterologists and Obesity

Of late, support has grown for gastroenterologists to become actively involved in obesity treatment — even to “take ownership” of this field.

In a 2023 article in Gut, Michael Camilleri, MD, AGAF, a gastroenterologist at the Mayo Clinic in Rochester, Minnesota, made the case for the natural fit between gastrointestinal (GI) specialists and obesity management. He noted that obesity is a significant risk factor for GI, pancreatic, and liver diseases. It can even affect inflammatory bowel disease.

A version of this article first appeared on Medscape.com.

TOPLINE:

Metformin significantly improved symptoms and resulted in hair regrowth in Black women with treatment-refractory central centrifugal cicatricial alopecia (CCCA), in a retrospective case series.

METHODOLOGY:

• Researchers conducted a case series involving 12 Black women in their 30s, 40s, and 50s, with biopsy-confirmed, treatment-refractory CCCA, a chronic inflammatory hair disorder characterized by permanent hair loss, from the Johns Hopkins University alopecia clinic.
• Participants received CCCA treatment for at least 6 months and had stagnant or worsening symptoms before oral extended-release metformin (500 mg daily) was added to treatment. (Treatments included topical clobetasol, compounded minoxidil, and platelet-rich plasma injections.)
• Scalp biopsies were collected from four patients before and after metformin treatment to evaluate gene expression changes.
• Changes in clinical symptoms were assessed, including pruritus, inflammation, pain, scalp resistance, and hair regrowth, following initiation of metformin treatment.

TAKEAWAY:

• Metformin led to significant clinical improvement in eight patients, which included reductions in scalp pain, scalp resistance, pruritus, and inflammation. However, two patients experienced worsening symptoms.
• Six patients showed clinical evidence of hair regrowth after at least 6 months of metformin treatment with one experiencing hair loss again 3 months after discontinuing treatment.
• Transcriptomic analysis revealed 34 upregulated genes, which included upregulated of 23 hair keratin-associated proteins, and pathways related to keratinization, epidermis development, and the hair cycle. In addition, eight genes were downregulated, with pathways that included those associated with extracellular matrix organization, collagen fibril organization, and collagen metabolism.
• Gene set variation analysis showed reduced expression of T helper 17 cell and epithelial-mesenchymal transition pathways and elevated adenosine monophosphate kinase signaling and keratin-associated proteins after treatment with metformin.

IN PRACTICE:

“Metformin’s ability to concomitantly target fibrosis and inflammation provides a plausible mechanism for its therapeutic effects in CCCA and other fibrosing alopecia disorders,” the authors concluded. But, they added, “larger prospective, placebo-controlled randomized clinical trials are needed to rigorously evaluate metformin’s efficacy and optimal dosing for treatment of cicatricial alopecias.”

SOURCE:

The study was led by Aaron Bao, Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, and was published online on September 4 in JAMA Dermatology.

LIMITATIONS:

A small sample size, retrospective design, lack of a placebo control group, and the single-center setting limited the generalizability of the study findings. In addition, the absence of a validated activity or severity scale for CCCA and the single posttreatment sampling limit the assessment and comparison of clinical symptoms and transcriptomic changes.

DISCLOSURES:

The study was supported by the American Academy of Dermatology. One author reported several ties with pharmaceutical companies, a pending patent, and authorship for the UpToDate section on CCCA.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Metformin significantly improved symptoms and resulted in hair regrowth in Black women with treatment-refractory central centrifugal cicatricial alopecia (CCCA), in a retrospective case series.

METHODOLOGY:

• Researchers conducted a case series involving 12 Black women in their 30s, 40s, and 50s, with biopsy-confirmed, treatment-refractory CCCA, a chronic inflammatory hair disorder characterized by permanent hair loss, from the Johns Hopkins University alopecia clinic.
• Participants received CCCA treatment for at least 6 months and had stagnant or worsening symptoms before oral extended-release metformin (500 mg daily) was added to treatment. (Treatments included topical clobetasol, compounded minoxidil, and platelet-rich plasma injections.)
• Scalp biopsies were collected from four patients before and after metformin treatment to evaluate gene expression changes.
• Changes in clinical symptoms were assessed, including pruritus, inflammation, pain, scalp resistance, and hair regrowth, following initiation of metformin treatment.

TAKEAWAY:

• Metformin led to significant clinical improvement in eight patients, which included reductions in scalp pain, scalp resistance, pruritus, and inflammation. However, two patients experienced worsening symptoms.
• Six patients showed clinical evidence of hair regrowth after at least 6 months of metformin treatment with one experiencing hair loss again 3 months after discontinuing treatment.
• Transcriptomic analysis revealed 34 upregulated genes, which included upregulated of 23 hair keratin-associated proteins, and pathways related to keratinization, epidermis development, and the hair cycle. In addition, eight genes were downregulated, with pathways that included those associated with extracellular matrix organization, collagen fibril organization, and collagen metabolism.
• Gene set variation analysis showed reduced expression of T helper 17 cell and epithelial-mesenchymal transition pathways and elevated adenosine monophosphate kinase signaling and keratin-associated proteins after treatment with metformin.

IN PRACTICE:

“Metformin’s ability to concomitantly target fibrosis and inflammation provides a plausible mechanism for its therapeutic effects in CCCA and other fibrosing alopecia disorders,” the authors concluded. But, they added, “larger prospective, placebo-controlled randomized clinical trials are needed to rigorously evaluate metformin’s efficacy and optimal dosing for treatment of cicatricial alopecias.”

SOURCE:

The study was led by Aaron Bao, Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, and was published online on September 4 in JAMA Dermatology.

LIMITATIONS:

A small sample size, retrospective design, lack of a placebo control group, and the single-center setting limited the generalizability of the study findings. In addition, the absence of a validated activity or severity scale for CCCA and the single posttreatment sampling limit the assessment and comparison of clinical symptoms and transcriptomic changes.

DISCLOSURES:

The study was supported by the American Academy of Dermatology. One author reported several ties with pharmaceutical companies, a pending patent, and authorship for the UpToDate section on CCCA.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Metformin significantly improved symptoms and resulted in hair regrowth in Black women with treatment-refractory central centrifugal cicatricial alopecia (CCCA), in a retrospective case series.

METHODOLOGY:

• Researchers conducted a case series involving 12 Black women in their 30s, 40s, and 50s, with biopsy-confirmed, treatment-refractory CCCA, a chronic inflammatory hair disorder characterized by permanent hair loss, from the Johns Hopkins University alopecia clinic.
• Participants received CCCA treatment for at least 6 months and had stagnant or worsening symptoms before oral extended-release metformin (500 mg daily) was added to treatment. (Treatments included topical clobetasol, compounded minoxidil, and platelet-rich plasma injections.)
• Scalp biopsies were collected from four patients before and after metformin treatment to evaluate gene expression changes.
• Changes in clinical symptoms were assessed, including pruritus, inflammation, pain, scalp resistance, and hair regrowth, following initiation of metformin treatment.

TAKEAWAY:

• Metformin led to significant clinical improvement in eight patients, which included reductions in scalp pain, scalp resistance, pruritus, and inflammation. However, two patients experienced worsening symptoms.
• Six patients showed clinical evidence of hair regrowth after at least 6 months of metformin treatment with one experiencing hair loss again 3 months after discontinuing treatment.
• Transcriptomic analysis revealed 34 upregulated genes, which included upregulated of 23 hair keratin-associated proteins, and pathways related to keratinization, epidermis development, and the hair cycle. In addition, eight genes were downregulated, with pathways that included those associated with extracellular matrix organization, collagen fibril organization, and collagen metabolism.
• Gene set variation analysis showed reduced expression of T helper 17 cell and epithelial-mesenchymal transition pathways and elevated adenosine monophosphate kinase signaling and keratin-associated proteins after treatment with metformin.

IN PRACTICE:

“Metformin’s ability to concomitantly target fibrosis and inflammation provides a plausible mechanism for its therapeutic effects in CCCA and other fibrosing alopecia disorders,” the authors concluded. But, they added, “larger prospective, placebo-controlled randomized clinical trials are needed to rigorously evaluate metformin’s efficacy and optimal dosing for treatment of cicatricial alopecias.”

SOURCE:

The study was led by Aaron Bao, Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, and was published online on September 4 in JAMA Dermatology.

LIMITATIONS:

A small sample size, retrospective design, lack of a placebo control group, and the single-center setting limited the generalizability of the study findings. In addition, the absence of a validated activity or severity scale for CCCA and the single posttreatment sampling limit the assessment and comparison of clinical symptoms and transcriptomic changes.

DISCLOSURES:

The study was supported by the American Academy of Dermatology. One author reported several ties with pharmaceutical companies, a pending patent, and authorship for the UpToDate section on CCCA.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

The metabolically unhealthy obesity phenotype, with its multiple comorbidities, may be the most practical group of people with obesity to screen for Cushing syndrome rather than all patients with obesity.

METHODOLOGY:

• Obesity is a key clinical feature of Cushing syndrome and shares many overlapping characteristics. An ongoing debate continues about the need to screen patients with obesity for the rare endocrine disease, but phenotypes known as metabolically healthy or unhealthy obesity may help better define an at-risk population.
• To assess the prevalence of Cushing syndrome by metabolic health status, researchers conducted a retrospective study of 1008 patients with obesity (mean age, 40 years; 83% women; body mass index ≥ 30) seen at an endocrinology outpatient clinic in Turkey between December 2020 and June 2022.
• They screened patients for Cushing syndrome with an overnight dexamethasone suppression test (1 mg DST), an oral dexamethasone dose given at 11 PM followed by a fasting blood sample for cortisol measurement the next morning. A serum cortisol level < 1.8 mcg/dL indicated normal suppression.
• Patients were categorized into those with metabolically healthy obesity (n = 229) or metabolically unhealthy obesity (n = 779) based on the absence or presence of comorbidities such as diabetes, prediabetes, coronary artery disease, hypertension, or dyslipidemia.

TAKEAWAY:

• The overall prevalence of Cushing syndrome in the study cohort was 0.2%, with only two patients definitively diagnosed after more tests and the remaining 10 classified as having subclinical hypercortisolism.
• Cortisol levels following the 1 mg DST were higher in the metabolically unhealthy obesity group than in the metabolically healthy obesity group (P = .001).
• Among the 12 patients with unsuppressed levels of cortisol, 11 belonged to the metabolically unhealthy obesity group, indicating a strong association between metabolic health and the levels of cortisol.
• The test demonstrated a specificity of 99% and sensitivity of 100% for screening Cushing syndrome in patients with obesity.

IN PRACTICE:

“Screening all patients with obesity for CS [Cushing syndrome] without considering any associated metabolic conditions appears impractical and unnecessary in everyday clinical practice,” the authors wrote. “However, it may be more reasonable and applicable to selectively screen the patients with obesity having comorbidities such as DM [diabetes mellitus], hypertension, dyslipidemia, or coronary artery disease, which lead to a metabolically unhealthy phenotype, rather than all individuals with obesity,” they added.

SOURCE:

The study, led by Sema Hepsen, Ankara Etlik City Hospital, Department of Endocrinology and Metabolism, Ankara, Turkey, was published online in the International Journal of Obesity.

LIMITATIONS:

The single-center design of the study and inclusion of patients from a single racial group may limit the generalizability of the findings. The retrospective design prevented the retrieval of all relevant data on clinical features and fat distribution.

DISCLOSURES:

The study was supported by an open access funding provided by the Scientific and Technological Research Council of Türkiye. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

The metabolically unhealthy obesity phenotype, with its multiple comorbidities, may be the most practical group of people with obesity to screen for Cushing syndrome rather than all patients with obesity.

METHODOLOGY:

• Obesity is a key clinical feature of Cushing syndrome and shares many overlapping characteristics. An ongoing debate continues about the need to screen patients with obesity for the rare endocrine disease, but phenotypes known as metabolically healthy or unhealthy obesity may help better define an at-risk population.
• To assess the prevalence of Cushing syndrome by metabolic health status, researchers conducted a retrospective study of 1008 patients with obesity (mean age, 40 years; 83% women; body mass index ≥ 30) seen at an endocrinology outpatient clinic in Turkey between December 2020 and June 2022.
• They screened patients for Cushing syndrome with an overnight dexamethasone suppression test (1 mg DST), an oral dexamethasone dose given at 11 PM followed by a fasting blood sample for cortisol measurement the next morning. A serum cortisol level < 1.8 mcg/dL indicated normal suppression.
• Patients were categorized into those with metabolically healthy obesity (n = 229) or metabolically unhealthy obesity (n = 779) based on the absence or presence of comorbidities such as diabetes, prediabetes, coronary artery disease, hypertension, or dyslipidemia.

TAKEAWAY:

• The overall prevalence of Cushing syndrome in the study cohort was 0.2%, with only two patients definitively diagnosed after more tests and the remaining 10 classified as having subclinical hypercortisolism.
• Cortisol levels following the 1 mg DST were higher in the metabolically unhealthy obesity group than in the metabolically healthy obesity group (P = .001).
• Among the 12 patients with unsuppressed levels of cortisol, 11 belonged to the metabolically unhealthy obesity group, indicating a strong association between metabolic health and the levels of cortisol.
• The test demonstrated a specificity of 99% and sensitivity of 100% for screening Cushing syndrome in patients with obesity.

IN PRACTICE:

“Screening all patients with obesity for CS [Cushing syndrome] without considering any associated metabolic conditions appears impractical and unnecessary in everyday clinical practice,” the authors wrote. “However, it may be more reasonable and applicable to selectively screen the patients with obesity having comorbidities such as DM [diabetes mellitus], hypertension, dyslipidemia, or coronary artery disease, which lead to a metabolically unhealthy phenotype, rather than all individuals with obesity,” they added.

SOURCE:

The study, led by Sema Hepsen, Ankara Etlik City Hospital, Department of Endocrinology and Metabolism, Ankara, Turkey, was published online in the International Journal of Obesity.

LIMITATIONS:

The single-center design of the study and inclusion of patients from a single racial group may limit the generalizability of the findings. The retrospective design prevented the retrieval of all relevant data on clinical features and fat distribution.

DISCLOSURES:

The study was supported by an open access funding provided by the Scientific and Technological Research Council of Türkiye. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

The metabolically unhealthy obesity phenotype, with its multiple comorbidities, may be the most practical group of people with obesity to screen for Cushing syndrome rather than all patients with obesity.

METHODOLOGY:

• Obesity is a key clinical feature of Cushing syndrome and shares many overlapping characteristics. An ongoing debate continues about the need to screen patients with obesity for the rare endocrine disease, but phenotypes known as metabolically healthy or unhealthy obesity may help better define an at-risk population.
• To assess the prevalence of Cushing syndrome by metabolic health status, researchers conducted a retrospective study of 1008 patients with obesity (mean age, 40 years; 83% women; body mass index ≥ 30) seen at an endocrinology outpatient clinic in Turkey between December 2020 and June 2022.
• They screened patients for Cushing syndrome with an overnight dexamethasone suppression test (1 mg DST), an oral dexamethasone dose given at 11 PM followed by a fasting blood sample for cortisol measurement the next morning. A serum cortisol level < 1.8 mcg/dL indicated normal suppression.
• Patients were categorized into those with metabolically healthy obesity (n = 229) or metabolically unhealthy obesity (n = 779) based on the absence or presence of comorbidities such as diabetes, prediabetes, coronary artery disease, hypertension, or dyslipidemia.

TAKEAWAY:

• The overall prevalence of Cushing syndrome in the study cohort was 0.2%, with only two patients definitively diagnosed after more tests and the remaining 10 classified as having subclinical hypercortisolism.
• Cortisol levels following the 1 mg DST were higher in the metabolically unhealthy obesity group than in the metabolically healthy obesity group (P = .001).
• Among the 12 patients with unsuppressed levels of cortisol, 11 belonged to the metabolically unhealthy obesity group, indicating a strong association between metabolic health and the levels of cortisol.
• The test demonstrated a specificity of 99% and sensitivity of 100% for screening Cushing syndrome in patients with obesity.

IN PRACTICE:

“Screening all patients with obesity for CS [Cushing syndrome] without considering any associated metabolic conditions appears impractical and unnecessary in everyday clinical practice,” the authors wrote. “However, it may be more reasonable and applicable to selectively screen the patients with obesity having comorbidities such as DM [diabetes mellitus], hypertension, dyslipidemia, or coronary artery disease, which lead to a metabolically unhealthy phenotype, rather than all individuals with obesity,” they added.

SOURCE:

The study, led by Sema Hepsen, Ankara Etlik City Hospital, Department of Endocrinology and Metabolism, Ankara, Turkey, was published online in the International Journal of Obesity.

LIMITATIONS:

The single-center design of the study and inclusion of patients from a single racial group may limit the generalizability of the findings. The retrospective design prevented the retrieval of all relevant data on clinical features and fat distribution.

DISCLOSURES:

The study was supported by an open access funding provided by the Scientific and Technological Research Council of Türkiye. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Using a cell phone for at least one call per week is linked to a higher risk for cardiovascular disease (CVD), especially among smokers and patients with diabetes, according to a new UK Biobank analysis.

“We found that a poor sleep pattern, psychological distress, and neuroticism significantly mediated the positive association between weekly mobile phone usage time and the risk for incident CVD, with a mediating proportion of 5.11%, 11.50%, and 2.25%, respectively,” said principal investigator Xianhui Qin, MD, professor of nephrology at Southern Medical University, Guangzhou, China.

Poor sleep patterns and poor mental health could disrupt circadian rhythms and endocrine and metabolic functions, as well as increase inflammation, he explained.

In addition, chronic exposure to radiofrequency electromagnetic fields (RF-EMF) emitted from cell phones could lead to oxidative stress and an inflammatory response. Combined with smoking and diabetes, this exposure “may have a synergistic effect in increasing CVD risk,” Dr. Qin suggested.

The study was published online in the Canadian Journal of Cardiology.
 

Risk Underestimated?

The researchers aimed to examine the association of regular cell phone use with incident CVD and explore the mediating effects of sleep and mental health using linked hospital and mortality records.

Their analysis included 444,027 participants (mean age, 56 years; 44% men) without a history of CVD from the UK Biobank. A total of 378,161 participants were regular cell phone users.

Regular cell phone use was defined as at least one call per week. Weekly use was self-reported as the average time of calls per week during the previous 3 months.

The primary outcome was incident CVD. Secondary outcomes were each component of CVD (ie, coronary heart disease, stroke, atrial fibrillation, and heart failure) and increased carotid intima media thickness (CIMT).

Compared with nonregular cell phone users, regular users were younger, had higher proportions of current smokers and urban residents, and had lower proportions of history of hypertension and diabetes. They also had higher income, Townsend deprivation index, and body mass index, and lower education levels.

During a median follow-up of 12.3 years, 56,181 participants developed incident CVD. Compared with nonregular cell phone users, regular users had a significantly higher risk for incident CVD (hazard ratio, 1.04) and increased CIMT (odds ratio, 1.11).

Among regular cell phone users, the duration of cell phone use and hands-free device/speakerphone use during calls was not significantly associated with incident CVD. Yet a significant and positive dose-response relationship was seen between weekly cell phone usage time and the risk for CVD. The positive association was stronger in current vs noncurrent smokers and people with vs without diabetes.

To different extents, sleep patterns (5.11%), psychologic distress (11.5%), and neuroticism (2.25%) mediated the relationship between weekly cell phone usage time and the risk for incident CVD.

“Our study suggests that despite the advantages of mobile phone use, we should also pay attention to the potential harm of mobile phone use to cardiovascular health,” Dr. Qin said. “Future studies to assess the risk-benefit balance will help promote mobile phone use patterns that are conducive to cardiovascular health.”

Meanwhile, he added, “We encourage measures to reduce time spent on mobile phones to promote the primary prevention of CVD. On the other hand, improving sleep and mental health status may help reduce the higher risk of CVD associated with mobile phone use.”

There are several limitations to the study in addition to its observational nature, which cannot show cause and effect. The questionnaires on cell phone use were restricted to phone calls; other use patterns of cell phones (eg, messaging, watching videos, and browsing the web) were not considered. Although the researchers adjusted for many potential confounders, unmeasured confounding bias (eg, the type of cell phone used and other sources of RF-EMF) cannot be eliminated.
 

Weak Link?

In a comment, Nicholas Grubic, MSc, a PhD student in epidemiology at the University of Toronto, Ontario, Canada, and coauthor of a related editorial, said, “I found it interesting that there was a connection observed between mobile phone use and CVD. However, it is crucial to understand that this link appeared to be much weaker compared with other well-known cardiovascular risk factors, such as smoking, diabetes, and high blood pressure. For now, mobile phone use should not be a major concern for most people.”

Nevertheless, clinicians should encourage patients to practice healthy habits around their screen time, he advised. “This could include limiting mobile phone use before bedtime and taking regular breaks to engage in activities that promote heart health, such as exercising or spending time outdoors.

“For the time being, we probably won’t see mobile phone use included in standard assessments for cardiovascular risk or as a focal point of cardiovascular health promotion initiatives,” he added. Instead, clinicians should “focus on established risk factors that have a stronger impact on patients’ cardiovascular health.”

Nieca Goldberg, MD, a clinical associate professor of medicine at NYU Grossman School of Medicine in New York City and American Heart Association volunteer expert, had a similar message. “You don’t have to go back to using a landline,” she said. “Instead, patients should be more mindful of how much phone use is taking away from their physical activity, keeping them from sleeping, and causing them stress.” Clinicians should also remember to counsel smokers on smoking cessation.

“It would be important for future studies to look at time spent on the phone and the type of activities patients are doing on their phones, such as social media, calls, texts, movies, or streaming TV shows,” she said. “It would be important to see how phone use is leading to a sedentary lifestyle” and what that means for a larger, more diverse population.

The study was supported by the National Key R&D Program, the National Natural Science Foundation of China, and the Outstanding Youth Development Scheme of Nanfang Hospital, Southern Medical University. Dr. Qin, Dr. Grubic, and Dr. Goldberg reported having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Using a cell phone for at least one call per week is linked to a higher risk for cardiovascular disease (CVD), especially among smokers and patients with diabetes, according to a new UK Biobank analysis.

“We found that a poor sleep pattern, psychological distress, and neuroticism significantly mediated the positive association between weekly mobile phone usage time and the risk for incident CVD, with a mediating proportion of 5.11%, 11.50%, and 2.25%, respectively,” said principal investigator Xianhui Qin, MD, professor of nephrology at Southern Medical University, Guangzhou, China.

Poor sleep patterns and poor mental health could disrupt circadian rhythms and endocrine and metabolic functions, as well as increase inflammation, he explained.

In addition, chronic exposure to radiofrequency electromagnetic fields (RF-EMF) emitted from cell phones could lead to oxidative stress and an inflammatory response. Combined with smoking and diabetes, this exposure “may have a synergistic effect in increasing CVD risk,” Dr. Qin suggested.

The study was published online in the Canadian Journal of Cardiology.
 

Risk Underestimated?

The researchers aimed to examine the association of regular cell phone use with incident CVD and explore the mediating effects of sleep and mental health using linked hospital and mortality records.

Their analysis included 444,027 participants (mean age, 56 years; 44% men) without a history of CVD from the UK Biobank. A total of 378,161 participants were regular cell phone users.

Regular cell phone use was defined as at least one call per week. Weekly use was self-reported as the average time of calls per week during the previous 3 months.

The primary outcome was incident CVD. Secondary outcomes were each component of CVD (ie, coronary heart disease, stroke, atrial fibrillation, and heart failure) and increased carotid intima media thickness (CIMT).

Compared with nonregular cell phone users, regular users were younger, had higher proportions of current smokers and urban residents, and had lower proportions of history of hypertension and diabetes. They also had higher income, Townsend deprivation index, and body mass index, and lower education levels.

During a median follow-up of 12.3 years, 56,181 participants developed incident CVD. Compared with nonregular cell phone users, regular users had a significantly higher risk for incident CVD (hazard ratio, 1.04) and increased CIMT (odds ratio, 1.11).

Among regular cell phone users, the duration of cell phone use and hands-free device/speakerphone use during calls was not significantly associated with incident CVD. Yet a significant and positive dose-response relationship was seen between weekly cell phone usage time and the risk for CVD. The positive association was stronger in current vs noncurrent smokers and people with vs without diabetes.

To different extents, sleep patterns (5.11%), psychologic distress (11.5%), and neuroticism (2.25%) mediated the relationship between weekly cell phone usage time and the risk for incident CVD.

“Our study suggests that despite the advantages of mobile phone use, we should also pay attention to the potential harm of mobile phone use to cardiovascular health,” Dr. Qin said. “Future studies to assess the risk-benefit balance will help promote mobile phone use patterns that are conducive to cardiovascular health.”

Meanwhile, he added, “We encourage measures to reduce time spent on mobile phones to promote the primary prevention of CVD. On the other hand, improving sleep and mental health status may help reduce the higher risk of CVD associated with mobile phone use.”

There are several limitations to the study in addition to its observational nature, which cannot show cause and effect. The questionnaires on cell phone use were restricted to phone calls; other use patterns of cell phones (eg, messaging, watching videos, and browsing the web) were not considered. Although the researchers adjusted for many potential confounders, unmeasured confounding bias (eg, the type of cell phone used and other sources of RF-EMF) cannot be eliminated.
 

Weak Link?

In a comment, Nicholas Grubic, MSc, a PhD student in epidemiology at the University of Toronto, Ontario, Canada, and coauthor of a related editorial, said, “I found it interesting that there was a connection observed between mobile phone use and CVD. However, it is crucial to understand that this link appeared to be much weaker compared with other well-known cardiovascular risk factors, such as smoking, diabetes, and high blood pressure. For now, mobile phone use should not be a major concern for most people.”

Nevertheless, clinicians should encourage patients to practice healthy habits around their screen time, he advised. “This could include limiting mobile phone use before bedtime and taking regular breaks to engage in activities that promote heart health, such as exercising or spending time outdoors.

“For the time being, we probably won’t see mobile phone use included in standard assessments for cardiovascular risk or as a focal point of cardiovascular health promotion initiatives,” he added. Instead, clinicians should “focus on established risk factors that have a stronger impact on patients’ cardiovascular health.”

Nieca Goldberg, MD, a clinical associate professor of medicine at NYU Grossman School of Medicine in New York City and American Heart Association volunteer expert, had a similar message. “You don’t have to go back to using a landline,” she said. “Instead, patients should be more mindful of how much phone use is taking away from their physical activity, keeping them from sleeping, and causing them stress.” Clinicians should also remember to counsel smokers on smoking cessation.

“It would be important for future studies to look at time spent on the phone and the type of activities patients are doing on their phones, such as social media, calls, texts, movies, or streaming TV shows,” she said. “It would be important to see how phone use is leading to a sedentary lifestyle” and what that means for a larger, more diverse population.

The study was supported by the National Key R&D Program, the National Natural Science Foundation of China, and the Outstanding Youth Development Scheme of Nanfang Hospital, Southern Medical University. Dr. Qin, Dr. Grubic, and Dr. Goldberg reported having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Using a cell phone for at least one call per week is linked to a higher risk for cardiovascular disease (CVD), especially among smokers and patients with diabetes, according to a new UK Biobank analysis.

“We found that a poor sleep pattern, psychological distress, and neuroticism significantly mediated the positive association between weekly mobile phone usage time and the risk for incident CVD, with a mediating proportion of 5.11%, 11.50%, and 2.25%, respectively,” said principal investigator Xianhui Qin, MD, professor of nephrology at Southern Medical University, Guangzhou, China.

Poor sleep patterns and poor mental health could disrupt circadian rhythms and endocrine and metabolic functions, as well as increase inflammation, he explained.

In addition, chronic exposure to radiofrequency electromagnetic fields (RF-EMF) emitted from cell phones could lead to oxidative stress and an inflammatory response. Combined with smoking and diabetes, this exposure “may have a synergistic effect in increasing CVD risk,” Dr. Qin suggested.

The study was published online in the Canadian Journal of Cardiology.
 

Risk Underestimated?

The researchers aimed to examine the association of regular cell phone use with incident CVD and explore the mediating effects of sleep and mental health using linked hospital and mortality records.

Their analysis included 444,027 participants (mean age, 56 years; 44% men) without a history of CVD from the UK Biobank. A total of 378,161 participants were regular cell phone users.

Regular cell phone use was defined as at least one call per week. Weekly use was self-reported as the average time of calls per week during the previous 3 months.

The primary outcome was incident CVD. Secondary outcomes were each component of CVD (ie, coronary heart disease, stroke, atrial fibrillation, and heart failure) and increased carotid intima media thickness (CIMT).

Compared with nonregular cell phone users, regular users were younger, had higher proportions of current smokers and urban residents, and had lower proportions of history of hypertension and diabetes. They also had higher income, Townsend deprivation index, and body mass index, and lower education levels.

During a median follow-up of 12.3 years, 56,181 participants developed incident CVD. Compared with nonregular cell phone users, regular users had a significantly higher risk for incident CVD (hazard ratio, 1.04) and increased CIMT (odds ratio, 1.11).

Among regular cell phone users, the duration of cell phone use and hands-free device/speakerphone use during calls was not significantly associated with incident CVD. Yet a significant and positive dose-response relationship was seen between weekly cell phone usage time and the risk for CVD. The positive association was stronger in current vs noncurrent smokers and people with vs without diabetes.

To different extents, sleep patterns (5.11%), psychologic distress (11.5%), and neuroticism (2.25%) mediated the relationship between weekly cell phone usage time and the risk for incident CVD.

“Our study suggests that despite the advantages of mobile phone use, we should also pay attention to the potential harm of mobile phone use to cardiovascular health,” Dr. Qin said. “Future studies to assess the risk-benefit balance will help promote mobile phone use patterns that are conducive to cardiovascular health.”

Meanwhile, he added, “We encourage measures to reduce time spent on mobile phones to promote the primary prevention of CVD. On the other hand, improving sleep and mental health status may help reduce the higher risk of CVD associated with mobile phone use.”

There are several limitations to the study in addition to its observational nature, which cannot show cause and effect. The questionnaires on cell phone use were restricted to phone calls; other use patterns of cell phones (eg, messaging, watching videos, and browsing the web) were not considered. Although the researchers adjusted for many potential confounders, unmeasured confounding bias (eg, the type of cell phone used and other sources of RF-EMF) cannot be eliminated.
 

Weak Link?

In a comment, Nicholas Grubic, MSc, a PhD student in epidemiology at the University of Toronto, Ontario, Canada, and coauthor of a related editorial, said, “I found it interesting that there was a connection observed between mobile phone use and CVD. However, it is crucial to understand that this link appeared to be much weaker compared with other well-known cardiovascular risk factors, such as smoking, diabetes, and high blood pressure. For now, mobile phone use should not be a major concern for most people.”

Nevertheless, clinicians should encourage patients to practice healthy habits around their screen time, he advised. “This could include limiting mobile phone use before bedtime and taking regular breaks to engage in activities that promote heart health, such as exercising or spending time outdoors.

“For the time being, we probably won’t see mobile phone use included in standard assessments for cardiovascular risk or as a focal point of cardiovascular health promotion initiatives,” he added. Instead, clinicians should “focus on established risk factors that have a stronger impact on patients’ cardiovascular health.”

Nieca Goldberg, MD, a clinical associate professor of medicine at NYU Grossman School of Medicine in New York City and American Heart Association volunteer expert, had a similar message. “You don’t have to go back to using a landline,” she said. “Instead, patients should be more mindful of how much phone use is taking away from their physical activity, keeping them from sleeping, and causing them stress.” Clinicians should also remember to counsel smokers on smoking cessation.

“It would be important for future studies to look at time spent on the phone and the type of activities patients are doing on their phones, such as social media, calls, texts, movies, or streaming TV shows,” she said. “It would be important to see how phone use is leading to a sedentary lifestyle” and what that means for a larger, more diverse population.

The study was supported by the National Key R&D Program, the National Natural Science Foundation of China, and the Outstanding Youth Development Scheme of Nanfang Hospital, Southern Medical University. Dr. Qin, Dr. Grubic, and Dr. Goldberg reported having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A so-called “oatzempic” diet has been bouncing around the internet posing as a cheap — and available — weight loss alternative to Ozempic.

Fans of the diet, made trendy by TikTok postings and a clever name, claim that an oat-based smoothie helps people quickly shed lots of weight. The smoothie is made by blending 1/2 cup of oats, 1 cup of water, a squeeze of lime, and maybe a dash of cinnamon or other flavoring agents, typically as the first meal of the day, often after fasting, followed by normal meals.

Despite the hype, the oatzempic drink is a far cry from Ozempic (semaglutide), the glucagon-like peptide 1 (GLP-1) medication the Food and Drug Administration has approved only for type 2 diabetes management but used off label for weight loss.

So how do pulverized oats stack up against prescription-based GLP-1s? According to two nutrition experts, they’re not as effective as some TikTok influencers claim. And in people with diabetes, the diet can be dangerous.
 

Nutritionists Answer Questions on Oatzempic

Caroline West Passerrello, EdD, RDN, LDN, an instructor and community coordinator in the School of Health and Rehabilitation Sciences at the University of Pittsburgh, Pennsylvania, and Emma Laing, PhD, RDN, LD, a clinical professor and director of dietetics in the College of Family and Consumer Sciences at the University of Georgia, Athens, talked about this fad in emails.

Can the ‘oatzempic’ diet help people lose weight?

Dr. Passerrello: Oats are particularly high in soluble fiber, and high-fiber foods can increase the natural production of GLPs. But studies are mixed on whether this happens when eating oats.

The high content of soluble beta-glucan fiber in oats and the appetite-suppressing citric acid in lime can potentially promote decreased appetite and increased satiety. But a bowl of oatmeal, though not as trendy, will probably produce the same results.

Is the oatzempic diet safe for people with type 2 diabetes?

Dr. Laing: This diet has the potential to cause harm. The diet and the drug are not similar in mechanism of action or strength of scientific evidence to support their role in diabetes and weight management. There is no evidence that this concoction provides the same outcomes as GLP-1 agonists. Rapid weight loss is unsustainable and can be harmful, and frequent spikes in blood sugar can harm adults and children with diabetes. So the oatzempic diet’s safety depends on the rate of weight loss and the effect on blood sugar. While it provides beta-glucan from oats and citric acid from lime juice, it is missing protein, healthy fats, and other vitamins and minerals that enhance the nutrient content and stabilize blood sugar.

Maintaining relatively consistent, normal-range blood glucose concentrations is key for managing diabetes and lowering the risks for other health complications. Carbohydrate sources consumed on their own can produce greater blood sugar fluctuations than when combined with proteins and fats, which slow carbohydrate digestion speed. So pairing oats with fruits, vegetables, healthy fats, and protein sources enhances the flavor, texture, and nutrient composition of the dish and can help slow the postprandial rise in blood glucose.

In the long term, any restrictive fad diet likely cannot be sustained and increases the risk for malnutrition, metabolic rate slowing to conserve energy, depression, social isolation, or eating disorder.

Additional considerations apply to children, with or without diabetes. Restrictive, extreme diets that promise quick results typically “work” by promoting body water and muscle mass losses. Such diets are not only contraindicated in children, who are undergoing rapid growth and development, but also unsustainable and can lead to physical and psychological problems that carry into adulthood.

What strategies and tactics can physicians use to effectively communicate with their patients about safe and effective diets?

Dr. Laing: Encourage patients to be skeptical of social media trends that seem too good to be true. Many [social media] creators lack the education or professional credentials to offer sound nutrition advice, and their posts could do harm. Explain that individual nutrition needs differ considerably based on age, activity patterns, health conditions, and medications, and one person’s way of eating or success is often not realistic for someone else.

Encourage open dialogue and provide nonjudgmental advice. If the taste of oatzempic intrigues patients, there is likely no harm in experimenting. Work on ensuring their meals are adequate in calories and contain sources of protein and healthy fats to prevent spikes in blood glucose. It’s crucial to communicate that weight loss doesn’t always equate with improved health.

Sharing information from the Academy of Nutrition and Dietetics and the American Diabetes Association can equip patients with tools they can implement under their clinician’s guidance. A provider’s greatest ally in diabetes care is a registered dietitian nutritionist (RDN) who is a Certified Diabetes Care and Education Specialist. RDNs will determine specific energy and nutrient needs and provide medical nutrition therapy such as carbohydrate counting, simplified meal plans, healthy food choices, exchange lists, and behavior strategies to help patients manage their diabetes. Many insurance plans cover these services.

What additional comments would you like to share with clinicians whose patients may ask them about the oatzempic diet?

Dr. Passerrello: What we do consistently matters. If your patient likes the taste of oatzempic in one meal a day, it’s a way to get more oats into their diet, if they focus their other meals on vegetables, fruits, whole grains, lean protein, and unsaturated fats.

Diets are out, and sustainable dietary patterns are in. Diets are one-size-fits-all, whereas a sustainable dietary pattern is individualized based on a person’s goals, medical history, taste preferences, budget, and lifestyle. Visit MyPlate.gov or work with an RDN [visit https://www.eatright.org/find-a-nutrition-expert to find nutritionists near your patients] to determine what a sustainable dietary pattern looks like.

What do clinicians need to know about claims on social media that a related drink — ‘ricezempic’ — aids weight loss?

Dr. Laing: Ricezempic promoters claim that drinking the beverage — typically made by soaking 1/2 cup of uncooked white rice in 1 cup of water and the juice from half a lime, then discarding the rice and drinking the liquid before breakfast — will lead to weight loss because the strained water provides a small dose of resistant starch, which is a source of prebiotics. Studies have shown that ingesting prebiotics may help lower blood cholesterol, improve blood glucose and insulin sensitivity, and benefit digestive function; however, more research is needed to determine specifics and if prebiotics are proven for weight loss.

Does ricezempic work?

Dr. Laing: There is no evidence that this concoction provides the same outcomes as GLP-1 agonists. The diet and the drug are not similar in mechanism of action or strength of scientific evidence to support their role in diabetes and weight management. Even if ricezempic provides a small amount of resistant starch and hydration from the rice water and citric acid from the lime juice, it is missing fiber, protein, healthy fats, and other vitamins and minerals that enhance the nutrient content of a meal or snack and stabilize blood sugar.

What advice do you have for clinicians whose patients with diabetes ask them about ricezempic?

Dr. Laing: I would not suggest that patients rely on ricezempic to support their health. There is no scientific evidence to show that people will lose weight in the short or long term by drinking ricezempic before a meal (or as a meal replacement).

If your patients are aiming to increase their intake of prebiotics, they are naturally found in various vegetables, fruits, whole grains, and seeds and in yogurt and high-fiber breads and cereals. A nutritious eating pattern that includes these foods is most beneficial for health.

A version of this article first appeared on Medscape.com.

A so-called “oatzempic” diet has been bouncing around the internet posing as a cheap — and available — weight loss alternative to Ozempic.

Fans of the diet, made trendy by TikTok postings and a clever name, claim that an oat-based smoothie helps people quickly shed lots of weight. The smoothie is made by blending 1/2 cup of oats, 1 cup of water, a squeeze of lime, and maybe a dash of cinnamon or other flavoring agents, typically as the first meal of the day, often after fasting, followed by normal meals.

Despite the hype, the oatzempic drink is a far cry from Ozempic (semaglutide), the glucagon-like peptide 1 (GLP-1) medication the Food and Drug Administration has approved only for type 2 diabetes management but used off label for weight loss.

So how do pulverized oats stack up against prescription-based GLP-1s? According to two nutrition experts, they’re not as effective as some TikTok influencers claim. And in people with diabetes, the diet can be dangerous.
 

Nutritionists Answer Questions on Oatzempic

Caroline West Passerrello, EdD, RDN, LDN, an instructor and community coordinator in the School of Health and Rehabilitation Sciences at the University of Pittsburgh, Pennsylvania, and Emma Laing, PhD, RDN, LD, a clinical professor and director of dietetics in the College of Family and Consumer Sciences at the University of Georgia, Athens, talked about this fad in emails.

Can the ‘oatzempic’ diet help people lose weight?

Dr. Passerrello: Oats are particularly high in soluble fiber, and high-fiber foods can increase the natural production of GLPs. But studies are mixed on whether this happens when eating oats.

The high content of soluble beta-glucan fiber in oats and the appetite-suppressing citric acid in lime can potentially promote decreased appetite and increased satiety. But a bowl of oatmeal, though not as trendy, will probably produce the same results.

Is the oatzempic diet safe for people with type 2 diabetes?

Dr. Laing: This diet has the potential to cause harm. The diet and the drug are not similar in mechanism of action or strength of scientific evidence to support their role in diabetes and weight management. There is no evidence that this concoction provides the same outcomes as GLP-1 agonists. Rapid weight loss is unsustainable and can be harmful, and frequent spikes in blood sugar can harm adults and children with diabetes. So the oatzempic diet’s safety depends on the rate of weight loss and the effect on blood sugar. While it provides beta-glucan from oats and citric acid from lime juice, it is missing protein, healthy fats, and other vitamins and minerals that enhance the nutrient content and stabilize blood sugar.

Maintaining relatively consistent, normal-range blood glucose concentrations is key for managing diabetes and lowering the risks for other health complications. Carbohydrate sources consumed on their own can produce greater blood sugar fluctuations than when combined with proteins and fats, which slow carbohydrate digestion speed. So pairing oats with fruits, vegetables, healthy fats, and protein sources enhances the flavor, texture, and nutrient composition of the dish and can help slow the postprandial rise in blood glucose.

In the long term, any restrictive fad diet likely cannot be sustained and increases the risk for malnutrition, metabolic rate slowing to conserve energy, depression, social isolation, or eating disorder.

Additional considerations apply to children, with or without diabetes. Restrictive, extreme diets that promise quick results typically “work” by promoting body water and muscle mass losses. Such diets are not only contraindicated in children, who are undergoing rapid growth and development, but also unsustainable and can lead to physical and psychological problems that carry into adulthood.

What strategies and tactics can physicians use to effectively communicate with their patients about safe and effective diets?

Dr. Laing: Encourage patients to be skeptical of social media trends that seem too good to be true. Many [social media] creators lack the education or professional credentials to offer sound nutrition advice, and their posts could do harm. Explain that individual nutrition needs differ considerably based on age, activity patterns, health conditions, and medications, and one person’s way of eating or success is often not realistic for someone else.

Encourage open dialogue and provide nonjudgmental advice. If the taste of oatzempic intrigues patients, there is likely no harm in experimenting. Work on ensuring their meals are adequate in calories and contain sources of protein and healthy fats to prevent spikes in blood glucose. It’s crucial to communicate that weight loss doesn’t always equate with improved health.

Sharing information from the Academy of Nutrition and Dietetics and the American Diabetes Association can equip patients with tools they can implement under their clinician’s guidance. A provider’s greatest ally in diabetes care is a registered dietitian nutritionist (RDN) who is a Certified Diabetes Care and Education Specialist. RDNs will determine specific energy and nutrient needs and provide medical nutrition therapy such as carbohydrate counting, simplified meal plans, healthy food choices, exchange lists, and behavior strategies to help patients manage their diabetes. Many insurance plans cover these services.

What additional comments would you like to share with clinicians whose patients may ask them about the oatzempic diet?

Dr. Passerrello: What we do consistently matters. If your patient likes the taste of oatzempic in one meal a day, it’s a way to get more oats into their diet, if they focus their other meals on vegetables, fruits, whole grains, lean protein, and unsaturated fats.

Diets are out, and sustainable dietary patterns are in. Diets are one-size-fits-all, whereas a sustainable dietary pattern is individualized based on a person’s goals, medical history, taste preferences, budget, and lifestyle. Visit MyPlate.gov or work with an RDN [visit https://www.eatright.org/find-a-nutrition-expert to find nutritionists near your patients] to determine what a sustainable dietary pattern looks like.

What do clinicians need to know about claims on social media that a related drink — ‘ricezempic’ — aids weight loss?

Dr. Laing: Ricezempic promoters claim that drinking the beverage — typically made by soaking 1/2 cup of uncooked white rice in 1 cup of water and the juice from half a lime, then discarding the rice and drinking the liquid before breakfast — will lead to weight loss because the strained water provides a small dose of resistant starch, which is a source of prebiotics. Studies have shown that ingesting prebiotics may help lower blood cholesterol, improve blood glucose and insulin sensitivity, and benefit digestive function; however, more research is needed to determine specifics and if prebiotics are proven for weight loss.

Does ricezempic work?

Dr. Laing: There is no evidence that this concoction provides the same outcomes as GLP-1 agonists. The diet and the drug are not similar in mechanism of action or strength of scientific evidence to support their role in diabetes and weight management. Even if ricezempic provides a small amount of resistant starch and hydration from the rice water and citric acid from the lime juice, it is missing fiber, protein, healthy fats, and other vitamins and minerals that enhance the nutrient content of a meal or snack and stabilize blood sugar.

What advice do you have for clinicians whose patients with diabetes ask them about ricezempic?

Dr. Laing: I would not suggest that patients rely on ricezempic to support their health. There is no scientific evidence to show that people will lose weight in the short or long term by drinking ricezempic before a meal (or as a meal replacement).

If your patients are aiming to increase their intake of prebiotics, they are naturally found in various vegetables, fruits, whole grains, and seeds and in yogurt and high-fiber breads and cereals. A nutritious eating pattern that includes these foods is most beneficial for health.

A version of this article first appeared on Medscape.com.

A so-called “oatzempic” diet has been bouncing around the internet posing as a cheap — and available — weight loss alternative to Ozempic.

Fans of the diet, made trendy by TikTok postings and a clever name, claim that an oat-based smoothie helps people quickly shed lots of weight. The smoothie is made by blending 1/2 cup of oats, 1 cup of water, a squeeze of lime, and maybe a dash of cinnamon or other flavoring agents, typically as the first meal of the day, often after fasting, followed by normal meals.

Despite the hype, the oatzempic drink is a far cry from Ozempic (semaglutide), the glucagon-like peptide 1 (GLP-1) medication the Food and Drug Administration has approved only for type 2 diabetes management but used off label for weight loss.

So how do pulverized oats stack up against prescription-based GLP-1s? According to two nutrition experts, they’re not as effective as some TikTok influencers claim. And in people with diabetes, the diet can be dangerous.
 

Nutritionists Answer Questions on Oatzempic

Caroline West Passerrello, EdD, RDN, LDN, an instructor and community coordinator in the School of Health and Rehabilitation Sciences at the University of Pittsburgh, Pennsylvania, and Emma Laing, PhD, RDN, LD, a clinical professor and director of dietetics in the College of Family and Consumer Sciences at the University of Georgia, Athens, talked about this fad in emails.

Can the ‘oatzempic’ diet help people lose weight?

Dr. Passerrello: Oats are particularly high in soluble fiber, and high-fiber foods can increase the natural production of GLPs. But studies are mixed on whether this happens when eating oats.

The high content of soluble beta-glucan fiber in oats and the appetite-suppressing citric acid in lime can potentially promote decreased appetite and increased satiety. But a bowl of oatmeal, though not as trendy, will probably produce the same results.

Is the oatzempic diet safe for people with type 2 diabetes?

Dr. Laing: This diet has the potential to cause harm. The diet and the drug are not similar in mechanism of action or strength of scientific evidence to support their role in diabetes and weight management. There is no evidence that this concoction provides the same outcomes as GLP-1 agonists. Rapid weight loss is unsustainable and can be harmful, and frequent spikes in blood sugar can harm adults and children with diabetes. So the oatzempic diet’s safety depends on the rate of weight loss and the effect on blood sugar. While it provides beta-glucan from oats and citric acid from lime juice, it is missing protein, healthy fats, and other vitamins and minerals that enhance the nutrient content and stabilize blood sugar.

Maintaining relatively consistent, normal-range blood glucose concentrations is key for managing diabetes and lowering the risks for other health complications. Carbohydrate sources consumed on their own can produce greater blood sugar fluctuations than when combined with proteins and fats, which slow carbohydrate digestion speed. So pairing oats with fruits, vegetables, healthy fats, and protein sources enhances the flavor, texture, and nutrient composition of the dish and can help slow the postprandial rise in blood glucose.

In the long term, any restrictive fad diet likely cannot be sustained and increases the risk for malnutrition, metabolic rate slowing to conserve energy, depression, social isolation, or eating disorder.

Additional considerations apply to children, with or without diabetes. Restrictive, extreme diets that promise quick results typically “work” by promoting body water and muscle mass losses. Such diets are not only contraindicated in children, who are undergoing rapid growth and development, but also unsustainable and can lead to physical and psychological problems that carry into adulthood.

What strategies and tactics can physicians use to effectively communicate with their patients about safe and effective diets?

Dr. Laing: Encourage patients to be skeptical of social media trends that seem too good to be true. Many [social media] creators lack the education or professional credentials to offer sound nutrition advice, and their posts could do harm. Explain that individual nutrition needs differ considerably based on age, activity patterns, health conditions, and medications, and one person’s way of eating or success is often not realistic for someone else.

Encourage open dialogue and provide nonjudgmental advice. If the taste of oatzempic intrigues patients, there is likely no harm in experimenting. Work on ensuring their meals are adequate in calories and contain sources of protein and healthy fats to prevent spikes in blood glucose. It’s crucial to communicate that weight loss doesn’t always equate with improved health.

Sharing information from the Academy of Nutrition and Dietetics and the American Diabetes Association can equip patients with tools they can implement under their clinician’s guidance. A provider’s greatest ally in diabetes care is a registered dietitian nutritionist (RDN) who is a Certified Diabetes Care and Education Specialist. RDNs will determine specific energy and nutrient needs and provide medical nutrition therapy such as carbohydrate counting, simplified meal plans, healthy food choices, exchange lists, and behavior strategies to help patients manage their diabetes. Many insurance plans cover these services.

What additional comments would you like to share with clinicians whose patients may ask them about the oatzempic diet?

Dr. Passerrello: What we do consistently matters. If your patient likes the taste of oatzempic in one meal a day, it’s a way to get more oats into their diet, if they focus their other meals on vegetables, fruits, whole grains, lean protein, and unsaturated fats.

Diets are out, and sustainable dietary patterns are in. Diets are one-size-fits-all, whereas a sustainable dietary pattern is individualized based on a person’s goals, medical history, taste preferences, budget, and lifestyle. Visit MyPlate.gov or work with an RDN [visit https://www.eatright.org/find-a-nutrition-expert to find nutritionists near your patients] to determine what a sustainable dietary pattern looks like.

What do clinicians need to know about claims on social media that a related drink — ‘ricezempic’ — aids weight loss?

Dr. Laing: Ricezempic promoters claim that drinking the beverage — typically made by soaking 1/2 cup of uncooked white rice in 1 cup of water and the juice from half a lime, then discarding the rice and drinking the liquid before breakfast — will lead to weight loss because the strained water provides a small dose of resistant starch, which is a source of prebiotics. Studies have shown that ingesting prebiotics may help lower blood cholesterol, improve blood glucose and insulin sensitivity, and benefit digestive function; however, more research is needed to determine specifics and if prebiotics are proven for weight loss.

Does ricezempic work?

Dr. Laing: There is no evidence that this concoction provides the same outcomes as GLP-1 agonists. The diet and the drug are not similar in mechanism of action or strength of scientific evidence to support their role in diabetes and weight management. Even if ricezempic provides a small amount of resistant starch and hydration from the rice water and citric acid from the lime juice, it is missing fiber, protein, healthy fats, and other vitamins and minerals that enhance the nutrient content of a meal or snack and stabilize blood sugar.

What advice do you have for clinicians whose patients with diabetes ask them about ricezempic?

Dr. Laing: I would not suggest that patients rely on ricezempic to support their health. There is no scientific evidence to show that people will lose weight in the short or long term by drinking ricezempic before a meal (or as a meal replacement).

If your patients are aiming to increase their intake of prebiotics, they are naturally found in various vegetables, fruits, whole grains, and seeds and in yogurt and high-fiber breads and cereals. A nutritious eating pattern that includes these foods is most beneficial for health.

A version of this article first appeared on Medscape.com.

LONDON — Updated guidelines for the management of atrial fibrillation released by the European Society of Cardiology are revamping the approach to care for this complex, multifactorial disease.

The identification and treatment of comorbidities and risk factors are the initial and central components of patient management, and are crucial for all other aspects of care for patients with atrial fibrillation (AF), Isabelle Van Gelder, MD, PhD, professor of cardiology at the University Medical Center in Groningen, the Netherlands, explained at the European Society of Cardiology (ESC) Congress.

It is not just appropriate to place the same emphasis on the control of comorbidities as on the rhythm disturbance, it is critical, said Dr. Van Gelder, who served as chair of the ESC-AF guidelines task force.

Comorbidities are the drivers of both the onset and recurrence of atrial fibrillation, and a dynamic approach to comorbidities is “central for the success of AF management.”
 

Class I Recommendation

In fact, on the basis of overwhelming evidence, a class I recommendation has been issued for a large number of goals in the comorbidity and risk factor management step of atrial fibrillation management, including those for hypertension, components of heart failure, obesity, diabetes, alcohol consumption, and exercise.

Sodium-glucose cotransporter-2 (SGLT2) inhibitors “should be offered to all patients with AF,” according to Dr. Van Gelder, who identified this as a new class I recommendation.

Patients who are not managed aggressively for the listed comorbidities ultimately face “treatment failure, poor patient outcomes, and a waste of healthcare resources,” she said.

Control of sleep apnea is also noted as a key target, although Van Gelder acknowledged that the supporting evidence only allows for a class IIb recommendation.

Control of comorbidities is not a new idea. In the 2023 joint guideline, led by a consortium of professional groups, including the American Heart Association (AHA) and the American College of Cardiology (ACC), the control of comorbidities, including most of those identified in the new ESC guidelines, was second in a list of 10 key take-home messages.

However, the new ESC guidelines have prioritized comorbidity management by listing it first in each of the specific patient-care pathways developed to define optimized care. 

These pathways, defined in algorithms for newly diagnosed AF, paroxysmal AF, and persistent AF, always start with the assessment of comorbidities, followed by step A — avoiding stroke — largely with anticoagulation.

Direct oral anticoagulants should be used, “except in those with a mechanical valve or mitral stenosis,” Dr. Van Gelder said. This includes, essentially, all patients with a CHA2DS2-VASc score of 2 or greater, and it should be “considered” in those with a score of 1. 

The ESC framework has been identified with the acronym AF-CARE, in which the C stands for comorbidities.

In the A step of the framework, identifying and treating all modifiable bleeding risk factors in AF patients is a class I recommendation. On the basis of a class III recommendation, she cautioned against withholding anticoagulants because of CHA2DS2-VASc risk factors alone. Rather, Dr. Van Gelder called the decision to administer or withhold anticoagulation — like all decisions — one that should be individualized in consultation with the patient.

For reducing AF symptoms and rhythm control, the specific pathways diverge for newly diagnosed AF, paroxysmal AF, and persistent AF. Like all of the guidelines, the specific options for symptom management and AF ablation are color coded, with green signifying level 1 evidence.

The evaluation and dynamic reassessment step refers to the need to periodically assess patients for new modifiable risk factors related to comorbidities, risk for stroke, risk for bleeding, and risk for AF. 

The management of risk factors for AF has long been emphasized in guidelines, but a previous focus on AF with attention to comorbidities has been replaced by a focus on comorbidities with an expectation of more durable AF control. The success of this pivot is based on multidisciplinary care, chosen in collaboration with the patient, to reduce or eliminate the triggers of AF and the risks of its complications.
 

Pathways Are Appropriate for All Patients

A very important recommendation — and this is new — is “to treat all our patients with atrial fibrillation, whether they are young or old, men or women, Black or White, or at high or low risk, according to our patient-centered integrated AF-CARE approach,” Dr. Van Gelder said.

The changes reflect a shared appreciation for the tight relation between the control of comorbidities and the control of AF, according to José A. Joglar, MD, professor of cardiac electrophysiologic research at the University of Texas Southwestern Medical Center in Dallas. Dr. Joglar was chair of the writing committee for the joint 2023 AF guidelines released by the AHA, ACC, the American College of Clinical Pharmacy, and the Heart Rhythm Society.

“It is increasingly clear that AF in many cases is the consequence of underlying risk factors and comorbidities, which cannot be separated from AF alone,” Dr. Joglar explained in an interview.

This was placed first “to emphasize the importance of viewing AFib as a complex disease that requires a holistic, multidisciplinary approach to care, as opposed to being viewed just as a rhythm abnormality,” he said.
 

A version of this article first appeared on Medscape.com.

LONDON — Updated guidelines for the management of atrial fibrillation released by the European Society of Cardiology are revamping the approach to care for this complex, multifactorial disease.

The identification and treatment of comorbidities and risk factors are the initial and central components of patient management, and are crucial for all other aspects of care for patients with atrial fibrillation (AF), Isabelle Van Gelder, MD, PhD, professor of cardiology at the University Medical Center in Groningen, the Netherlands, explained at the European Society of Cardiology (ESC) Congress.

It is not just appropriate to place the same emphasis on the control of comorbidities as on the rhythm disturbance, it is critical, said Dr. Van Gelder, who served as chair of the ESC-AF guidelines task force.

Comorbidities are the drivers of both the onset and recurrence of atrial fibrillation, and a dynamic approach to comorbidities is “central for the success of AF management.”
 

Class I Recommendation

In fact, on the basis of overwhelming evidence, a class I recommendation has been issued for a large number of goals in the comorbidity and risk factor management step of atrial fibrillation management, including those for hypertension, components of heart failure, obesity, diabetes, alcohol consumption, and exercise.

Sodium-glucose cotransporter-2 (SGLT2) inhibitors “should be offered to all patients with AF,” according to Dr. Van Gelder, who identified this as a new class I recommendation.

Patients who are not managed aggressively for the listed comorbidities ultimately face “treatment failure, poor patient outcomes, and a waste of healthcare resources,” she said.

Control of sleep apnea is also noted as a key target, although Van Gelder acknowledged that the supporting evidence only allows for a class IIb recommendation.

Control of comorbidities is not a new idea. In the 2023 joint guideline, led by a consortium of professional groups, including the American Heart Association (AHA) and the American College of Cardiology (ACC), the control of comorbidities, including most of those identified in the new ESC guidelines, was second in a list of 10 key take-home messages.

However, the new ESC guidelines have prioritized comorbidity management by listing it first in each of the specific patient-care pathways developed to define optimized care. 

These pathways, defined in algorithms for newly diagnosed AF, paroxysmal AF, and persistent AF, always start with the assessment of comorbidities, followed by step A — avoiding stroke — largely with anticoagulation.

Direct oral anticoagulants should be used, “except in those with a mechanical valve or mitral stenosis,” Dr. Van Gelder said. This includes, essentially, all patients with a CHA2DS2-VASc score of 2 or greater, and it should be “considered” in those with a score of 1. 

The ESC framework has been identified with the acronym AF-CARE, in which the C stands for comorbidities.

In the A step of the framework, identifying and treating all modifiable bleeding risk factors in AF patients is a class I recommendation. On the basis of a class III recommendation, she cautioned against withholding anticoagulants because of CHA2DS2-VASc risk factors alone. Rather, Dr. Van Gelder called the decision to administer or withhold anticoagulation — like all decisions — one that should be individualized in consultation with the patient.

For reducing AF symptoms and rhythm control, the specific pathways diverge for newly diagnosed AF, paroxysmal AF, and persistent AF. Like all of the guidelines, the specific options for symptom management and AF ablation are color coded, with green signifying level 1 evidence.

The evaluation and dynamic reassessment step refers to the need to periodically assess patients for new modifiable risk factors related to comorbidities, risk for stroke, risk for bleeding, and risk for AF. 

The management of risk factors for AF has long been emphasized in guidelines, but a previous focus on AF with attention to comorbidities has been replaced by a focus on comorbidities with an expectation of more durable AF control. The success of this pivot is based on multidisciplinary care, chosen in collaboration with the patient, to reduce or eliminate the triggers of AF and the risks of its complications.
 

Pathways Are Appropriate for All Patients

A very important recommendation — and this is new — is “to treat all our patients with atrial fibrillation, whether they are young or old, men or women, Black or White, or at high or low risk, according to our patient-centered integrated AF-CARE approach,” Dr. Van Gelder said.

The changes reflect a shared appreciation for the tight relation between the control of comorbidities and the control of AF, according to José A. Joglar, MD, professor of cardiac electrophysiologic research at the University of Texas Southwestern Medical Center in Dallas. Dr. Joglar was chair of the writing committee for the joint 2023 AF guidelines released by the AHA, ACC, the American College of Clinical Pharmacy, and the Heart Rhythm Society.

“It is increasingly clear that AF in many cases is the consequence of underlying risk factors and comorbidities, which cannot be separated from AF alone,” Dr. Joglar explained in an interview.

This was placed first “to emphasize the importance of viewing AFib as a complex disease that requires a holistic, multidisciplinary approach to care, as opposed to being viewed just as a rhythm abnormality,” he said.
 

A version of this article first appeared on Medscape.com.

LONDON — Updated guidelines for the management of atrial fibrillation released by the European Society of Cardiology are revamping the approach to care for this complex, multifactorial disease.

The identification and treatment of comorbidities and risk factors are the initial and central components of patient management, and are crucial for all other aspects of care for patients with atrial fibrillation (AF), Isabelle Van Gelder, MD, PhD, professor of cardiology at the University Medical Center in Groningen, the Netherlands, explained at the European Society of Cardiology (ESC) Congress.

It is not just appropriate to place the same emphasis on the control of comorbidities as on the rhythm disturbance, it is critical, said Dr. Van Gelder, who served as chair of the ESC-AF guidelines task force.

Comorbidities are the drivers of both the onset and recurrence of atrial fibrillation, and a dynamic approach to comorbidities is “central for the success of AF management.”
 

Class I Recommendation

In fact, on the basis of overwhelming evidence, a class I recommendation has been issued for a large number of goals in the comorbidity and risk factor management step of atrial fibrillation management, including those for hypertension, components of heart failure, obesity, diabetes, alcohol consumption, and exercise.

Sodium-glucose cotransporter-2 (SGLT2) inhibitors “should be offered to all patients with AF,” according to Dr. Van Gelder, who identified this as a new class I recommendation.

Patients who are not managed aggressively for the listed comorbidities ultimately face “treatment failure, poor patient outcomes, and a waste of healthcare resources,” she said.

Control of sleep apnea is also noted as a key target, although Van Gelder acknowledged that the supporting evidence only allows for a class IIb recommendation.

Control of comorbidities is not a new idea. In the 2023 joint guideline, led by a consortium of professional groups, including the American Heart Association (AHA) and the American College of Cardiology (ACC), the control of comorbidities, including most of those identified in the new ESC guidelines, was second in a list of 10 key take-home messages.

However, the new ESC guidelines have prioritized comorbidity management by listing it first in each of the specific patient-care pathways developed to define optimized care. 

These pathways, defined in algorithms for newly diagnosed AF, paroxysmal AF, and persistent AF, always start with the assessment of comorbidities, followed by step A — avoiding stroke — largely with anticoagulation.

Direct oral anticoagulants should be used, “except in those with a mechanical valve or mitral stenosis,” Dr. Van Gelder said. This includes, essentially, all patients with a CHA2DS2-VASc score of 2 or greater, and it should be “considered” in those with a score of 1. 

The ESC framework has been identified with the acronym AF-CARE, in which the C stands for comorbidities.

In the A step of the framework, identifying and treating all modifiable bleeding risk factors in AF patients is a class I recommendation. On the basis of a class III recommendation, she cautioned against withholding anticoagulants because of CHA2DS2-VASc risk factors alone. Rather, Dr. Van Gelder called the decision to administer or withhold anticoagulation — like all decisions — one that should be individualized in consultation with the patient.

For reducing AF symptoms and rhythm control, the specific pathways diverge for newly diagnosed AF, paroxysmal AF, and persistent AF. Like all of the guidelines, the specific options for symptom management and AF ablation are color coded, with green signifying level 1 evidence.

The evaluation and dynamic reassessment step refers to the need to periodically assess patients for new modifiable risk factors related to comorbidities, risk for stroke, risk for bleeding, and risk for AF. 

The management of risk factors for AF has long been emphasized in guidelines, but a previous focus on AF with attention to comorbidities has been replaced by a focus on comorbidities with an expectation of more durable AF control. The success of this pivot is based on multidisciplinary care, chosen in collaboration with the patient, to reduce or eliminate the triggers of AF and the risks of its complications.
 

Pathways Are Appropriate for All Patients

A very important recommendation — and this is new — is “to treat all our patients with atrial fibrillation, whether they are young or old, men or women, Black or White, or at high or low risk, according to our patient-centered integrated AF-CARE approach,” Dr. Van Gelder said.

The changes reflect a shared appreciation for the tight relation between the control of comorbidities and the control of AF, according to José A. Joglar, MD, professor of cardiac electrophysiologic research at the University of Texas Southwestern Medical Center in Dallas. Dr. Joglar was chair of the writing committee for the joint 2023 AF guidelines released by the AHA, ACC, the American College of Clinical Pharmacy, and the Heart Rhythm Society.

“It is increasingly clear that AF in many cases is the consequence of underlying risk factors and comorbidities, which cannot be separated from AF alone,” Dr. Joglar explained in an interview.

This was placed first “to emphasize the importance of viewing AFib as a complex disease that requires a holistic, multidisciplinary approach to care, as opposed to being viewed just as a rhythm abnormality,” he said.
 

A version of this article first appeared on Medscape.com.

TOPLINE:

A higher intake of lignans (found in plant-based foods such as seeds, whole grains, some fruits and vegetables, and coffee, tea, and cocoa) is linked to a reduced risk for type 2 diabetes (T2D), especially in individuals with obesity or premenopausal women.

METHODOLOGY:

• Lignans, polyphenolic compounds abundant in plant-based foods, are the primary dietary source of phytoestrogens in Western diets and are associated with a reduced risk for cardiometabolic conditions, but the relative associations of individual lignans with T2D are unknown.
• Researchers assessed the associations between the risk for T2D and the intake of total and four primary lignans using the data of 201,111 participants (mean age, 44.7 years; 80.2% women; 96.7% White individuals) from three large prospective US cohorts with over 30 years of follow-up, as well as the association between lignan intake and hemoglobin A1c in 496 participants from the Men’s Lifestyle Validation Study (MLVS).
• For the three large cohorts, lignan intake (total, secoisolariciresinol, matairesinol, pinoresinol, and lariciresinol) was assessed using a validated food frequency questionnaire updated every 2-4 years and categorized into quintiles. For MLVS, diet was assessed by two sets of 7-day diet records and presented as percentage changes in A1c for linear increases in lignan intake.
• Incident T2D was confirmed using diagnostic tests, symptoms, hypoglycemic medication, elevated glucose by several measures.

TAKEAWAY:

• Across the three cohorts, 20,291 cases of T2D were recorded in the full follow-up.
• Higher intakes of total and individual ligands, except for lariciresinol, were associated with about 8%-27% lower T2D incidents (approximate hazard ratio [HR], 0.72-0.93)
• Of the individual lignans, secoisolariciresinol (but not others) showed a significant inverse association with the risk for T2D among those with a body mass index ≥ 30 (HR, 0.75; 95% CI, 0.71-0.79) and premenopausal women (HR, 0.67; 95% CI, 0.65-0.69).
• The dietary intake of lignans assessed using the 7-day diet records in MLVS was associated with lower levels of A1c (percentage changes ranging from −0.92% to −1.50%.

IN PRACTICE:

“Our findings underscore the importance of a healthy plant-based diet rich in lignan-containing foods, including flaxseed products, whole grains, and coffee for the primary prevention of T2D,” the authors wrote.

SOURCE:

The study, led by Siyue Wang, PhD, Department of Nutrition, Harvard TH Chan School of Public Health, Boston, Massachusetts, and the School of Public Health, Peking University, Beijing, China, was published online in JAMA Network Open.

LIMITATIONS:

The study’s limitations include the potential for measurement errors in dietary assessments. Flax seed, the most concentrated source of lignans, was not assessed until midway through the three large cohort follow-ups, and this may have resulted in misclassification of the intake levels of secoisolariciresinol. The lack of diversity in the socioeconomic status and race within the population may restrict the generalizability of the findings. Despite making multivariable adjustments, residual confounding cannot be fully ruled out.

DISCLOSURES:

The three cohort studies were supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

A higher intake of lignans (found in plant-based foods such as seeds, whole grains, some fruits and vegetables, and coffee, tea, and cocoa) is linked to a reduced risk for type 2 diabetes (T2D), especially in individuals with obesity or premenopausal women.

METHODOLOGY:

• Lignans, polyphenolic compounds abundant in plant-based foods, are the primary dietary source of phytoestrogens in Western diets and are associated with a reduced risk for cardiometabolic conditions, but the relative associations of individual lignans with T2D are unknown.
• Researchers assessed the associations between the risk for T2D and the intake of total and four primary lignans using the data of 201,111 participants (mean age, 44.7 years; 80.2% women; 96.7% White individuals) from three large prospective US cohorts with over 30 years of follow-up, as well as the association between lignan intake and hemoglobin A1c in 496 participants from the Men’s Lifestyle Validation Study (MLVS).
• For the three large cohorts, lignan intake (total, secoisolariciresinol, matairesinol, pinoresinol, and lariciresinol) was assessed using a validated food frequency questionnaire updated every 2-4 years and categorized into quintiles. For MLVS, diet was assessed by two sets of 7-day diet records and presented as percentage changes in A1c for linear increases in lignan intake.
• Incident T2D was confirmed using diagnostic tests, symptoms, hypoglycemic medication, elevated glucose by several measures.

TAKEAWAY:

• Across the three cohorts, 20,291 cases of T2D were recorded in the full follow-up.
• Higher intakes of total and individual ligands, except for lariciresinol, were associated with about 8%-27% lower T2D incidents (approximate hazard ratio [HR], 0.72-0.93)
• Of the individual lignans, secoisolariciresinol (but not others) showed a significant inverse association with the risk for T2D among those with a body mass index ≥ 30 (HR, 0.75; 95% CI, 0.71-0.79) and premenopausal women (HR, 0.67; 95% CI, 0.65-0.69).
• The dietary intake of lignans assessed using the 7-day diet records in MLVS was associated with lower levels of A1c (percentage changes ranging from −0.92% to −1.50%.

IN PRACTICE:

“Our findings underscore the importance of a healthy plant-based diet rich in lignan-containing foods, including flaxseed products, whole grains, and coffee for the primary prevention of T2D,” the authors wrote.

SOURCE:

The study, led by Siyue Wang, PhD, Department of Nutrition, Harvard TH Chan School of Public Health, Boston, Massachusetts, and the School of Public Health, Peking University, Beijing, China, was published online in JAMA Network Open.

LIMITATIONS:

The study’s limitations include the potential for measurement errors in dietary assessments. Flax seed, the most concentrated source of lignans, was not assessed until midway through the three large cohort follow-ups, and this may have resulted in misclassification of the intake levels of secoisolariciresinol. The lack of diversity in the socioeconomic status and race within the population may restrict the generalizability of the findings. Despite making multivariable adjustments, residual confounding cannot be fully ruled out.

DISCLOSURES:

The three cohort studies were supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

A higher intake of lignans (found in plant-based foods such as seeds, whole grains, some fruits and vegetables, and coffee, tea, and cocoa) is linked to a reduced risk for type 2 diabetes (T2D), especially in individuals with obesity or premenopausal women.

METHODOLOGY:

• Lignans, polyphenolic compounds abundant in plant-based foods, are the primary dietary source of phytoestrogens in Western diets and are associated with a reduced risk for cardiometabolic conditions, but the relative associations of individual lignans with T2D are unknown.
• Researchers assessed the associations between the risk for T2D and the intake of total and four primary lignans using the data of 201,111 participants (mean age, 44.7 years; 80.2% women; 96.7% White individuals) from three large prospective US cohorts with over 30 years of follow-up, as well as the association between lignan intake and hemoglobin A1c in 496 participants from the Men’s Lifestyle Validation Study (MLVS).
• For the three large cohorts, lignan intake (total, secoisolariciresinol, matairesinol, pinoresinol, and lariciresinol) was assessed using a validated food frequency questionnaire updated every 2-4 years and categorized into quintiles. For MLVS, diet was assessed by two sets of 7-day diet records and presented as percentage changes in A1c for linear increases in lignan intake.
• Incident T2D was confirmed using diagnostic tests, symptoms, hypoglycemic medication, elevated glucose by several measures.

TAKEAWAY:

• Across the three cohorts, 20,291 cases of T2D were recorded in the full follow-up.
• Higher intakes of total and individual ligands, except for lariciresinol, were associated with about 8%-27% lower T2D incidents (approximate hazard ratio [HR], 0.72-0.93)
• Of the individual lignans, secoisolariciresinol (but not others) showed a significant inverse association with the risk for T2D among those with a body mass index ≥ 30 (HR, 0.75; 95% CI, 0.71-0.79) and premenopausal women (HR, 0.67; 95% CI, 0.65-0.69).
• The dietary intake of lignans assessed using the 7-day diet records in MLVS was associated with lower levels of A1c (percentage changes ranging from −0.92% to −1.50%.

IN PRACTICE:

“Our findings underscore the importance of a healthy plant-based diet rich in lignan-containing foods, including flaxseed products, whole grains, and coffee for the primary prevention of T2D,” the authors wrote.

SOURCE:

The study, led by Siyue Wang, PhD, Department of Nutrition, Harvard TH Chan School of Public Health, Boston, Massachusetts, and the School of Public Health, Peking University, Beijing, China, was published online in JAMA Network Open.

LIMITATIONS:

The study’s limitations include the potential for measurement errors in dietary assessments. Flax seed, the most concentrated source of lignans, was not assessed until midway through the three large cohort follow-ups, and this may have resulted in misclassification of the intake levels of secoisolariciresinol. The lack of diversity in the socioeconomic status and race within the population may restrict the generalizability of the findings. Despite making multivariable adjustments, residual confounding cannot be fully ruled out.

DISCLOSURES:

The three cohort studies were supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity. 

Akshay B. Jain, MD: I’m Dr. Akshay Jain, an endocrinologist from Vancouver, and I’m joined by Dr. James Kim, a primary care physician from Calgary, Canada. 

Both Dr. Kim and I attended ADA 2024. We went over all our learnings and decided that there was a whole heap of clinical pearls that we learned from the conference. We thought it would be awesome if we could share our learnings with all of you, both from a primary care lens and from an endocrinology perspective.

One study Dr. Kim and I learned about, and we think has some definite nuances in management of people living with diabetes, regards inhaled insulin. When we have patients in our clinic who have perhaps failed multiple oral agents or have very high blood sugars, we obviously want to consider starting them on insulin for type 2 diabetes.

Sometimes there is a significant barrier, which is related to the needles. There’s an actual term for this: trypanophobia — a fear of needles. For the longest time, people have not wanted to take insulin or injectables because there’s only one way of administering it, which is subcutaneous.

Enter now inhaled insulin. We saw studies at the ADA 2024 conference that looked at a new inhaled insulin called Afrezza. Afrezza essentially is a short-acting insulin, so it’s kind of like a prandial insulin derivative, where it can be inhaled by an individual and it will work for mealtime control of blood sugars.

Dr. Kim, in your practice, how often do you see people not wanting to take shots, and has this been a big barrier for you in starting insulin? 

James W. Kim, MBBCh, PgDip, MScCH: Thank you for having me. To answer your question, absolutely I encounter this on a weekly basis — and I’m not even an endocrinologist. I just have an interest in diabetes. There are a number of patients that I think will benefit massively with insulin but they’re needle-phobic. You taught me that word, but I can never pronounce it, so my apologies for not remembering that phobia. I’m just going to call it needle phobia because I’m a simple-minded person.

The needle phobia is massive. I think there’s a definite fear of the needle, but there’s also a fear of failure. As soon as an injection is mentioned, many patients feel they failed miserably. There’s an emotional roller coaster that happens.

I’m sure, Dr. Jain, you have seen many patients, especially from Asia, who would say: “Oh, my auntie got on insulin and 3 months later, she got a kidney transplant.” “My uncle started on insulin and he unfortunately passed away a couple of months later.” Unfortunately, they’re blaming many of those things on insulin.

I also have a number of patients who said they were on insulin before many years ago, and they experienced some severe hypoglycemic events, and they don’t want to get on the insulin ever again. This is unfortunate because you know that if those patients, those aunties and uncles, were on insulin long before, maybe we could have saved their legs and kidneys, and potentially death.

Now we have advanced so much with insulin that hypoglycemia does occur, but much less than before. We still have many barriers when it comes to insulin initiations. Therefore, having this idea of inhaled insulin is fantastic, and I think we can get many more patients on insulin — the medication they actually need.

Dr. Jain: Absolutely. From the studies on inhaled insulin at ADA 2024, the key thing I found very interesting, regarding the pharmacokinetics of the insulin, was that it’s working very quickly. It starts working within minutes of administering it.

Additionally, it lasts in the body only for a shorter duration of time, compared with other injectable short-acting insulins, so it lasts in the body. The active insulin time is roughly about 2 hours or so, based on the studies, which in my mind opens up a whole world of possibilities because it means that people can take another correctional insulin if the blood sugars are still high after taking their first inhaled dose. You can take another dose subsequently without worrying about stacking of insulin. 

Many of us are familiar with this term, which is if you take two shots of short-acting insulin too close to each other, the insulin doses might add up and there can be a big drop in the blood sugars; it’s called stacking of insulin. This can be potentially avoided. 

Similarly, if you take your dinnertime inhaled insulin and the sugars are still high around bedtime, you could take a smaller dose of the inhaled insulin and not worry about middle-of-the-night hypoglycemia because the effect of the insulin would be only for a little while.

That’s one key learning that I found very helpful. The other important thing that I found was that this is not for everyone, so there are some restrictions. Essentially, the contraindication is that people who have asthma or COPD cannot be prescribed an inhaled insulin.

What are your thoughts, Dr. Kim, based on this for your practice in primary care? 

Dr. Kim: It is very fascinating, for sure. I cannot wait to get hold of this insulin. I can already think of some patients who may benefit. You’ve mentioned the asthma and COPD patients, and that makes more sense because there is an actual airway problem.

I also wonder what will happen to patients who have restrictive airway disease, where asthma and COPD fall under obstructive airway disease. What if they have obesity, where it’s really pressing into the diaphragm, and where they may not be able to take the deep breath in? How will they react?

What about someone who’s got a cold, someone who has postnasal drip, or someone who tends to cough frequently? What about egg allergies? There are many question marks around this insulin before initiating these medications. There is excitement, but there are also many questions at the same time.

Dr. Jain: I think these are very important, practical considerations that we’ll uncover as we start using more of this in clinical practice. The other important thing to note is that the presenters told us it’s important to monitor pulmonary function tests. It’s important to get a baseline pulmonary function test, and then we have to do another one in 6 months, followed by annually thereafter.

If, at any point of time, the FEV1 drops by 20% or more, then that would be an indication for discontinuation of the inhaled insulin. The pulmonary function test does not need to be one of those fancier ones. The study group would just do office spirometries. I’m wondering, Dr. Kim, in primary care, do you think this could potentially be a rate-limiting factor?

Dr. Kim: In Alberta, where I reside, no. Spirometry is very easily accessible in the province. For example, in Calgary alone, we have a population of about 1.3 million people. We have over 13 or 15 companies that can do this spirometry. We can get these things done literally within a week or 2.

However, I am aware that, in other provinces in Canada, it can definitely be a huge rate-limiting factor. Not everyone has the office-based spirometry, and definitely not within the primary care office. It has to be referred out to these private companies, most likely, and some of the rural areas will have to rely on the provincial hospitals, where the access can be even more challenging. 

On the day of the actual spirometry, if the person has a cough or is not feeling well, it’s going to be a problem because you don’t want the spirometry to be infected with a whole bunch of viruses. You’ll have to cancel that and it can be a bit of an issue.

Dr. Jain: Many of our viewers are from the United States and other parts of the world, and spirometry is quite easily accessible in most places. As an endocrinologist, I must confess that it’s been a long time since I’ve even ordered a spirometry or any clinical form of pulmonary function test. Once I start using the inhaled insulin, I’ll need to start brushing up on my pulmonary function test knowledge. 

I think these are exciting times. At least we’ve got something to offer to people who would have otherwise not taken any insulin at all. There’s certainly that hope that now there’s a different way to administer this, and hopefully it can only get better from here on.
 

Dr. Jain is a clinical instructor, Department of Endocrinology, University of British Columbia, Vancouver. Dr. Kim is a clinical assistant professor, Department of Family Medicine, University of Calgary in Alberta. Both disclosed conflicts of interest with numerous pharmaceutical companies.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity. 

Akshay B. Jain, MD: I’m Dr. Akshay Jain, an endocrinologist from Vancouver, and I’m joined by Dr. James Kim, a primary care physician from Calgary, Canada. 

Both Dr. Kim and I attended ADA 2024. We went over all our learnings and decided that there was a whole heap of clinical pearls that we learned from the conference. We thought it would be awesome if we could share our learnings with all of you, both from a primary care lens and from an endocrinology perspective.

One study Dr. Kim and I learned about, and we think has some definite nuances in management of people living with diabetes, regards inhaled insulin. When we have patients in our clinic who have perhaps failed multiple oral agents or have very high blood sugars, we obviously want to consider starting them on insulin for type 2 diabetes.

Sometimes there is a significant barrier, which is related to the needles. There’s an actual term for this: trypanophobia — a fear of needles. For the longest time, people have not wanted to take insulin or injectables because there’s only one way of administering it, which is subcutaneous.

Enter now inhaled insulin. We saw studies at the ADA 2024 conference that looked at a new inhaled insulin called Afrezza. Afrezza essentially is a short-acting insulin, so it’s kind of like a prandial insulin derivative, where it can be inhaled by an individual and it will work for mealtime control of blood sugars.

Dr. Kim, in your practice, how often do you see people not wanting to take shots, and has this been a big barrier for you in starting insulin? 

James W. Kim, MBBCh, PgDip, MScCH: Thank you for having me. To answer your question, absolutely I encounter this on a weekly basis — and I’m not even an endocrinologist. I just have an interest in diabetes. There are a number of patients that I think will benefit massively with insulin but they’re needle-phobic. You taught me that word, but I can never pronounce it, so my apologies for not remembering that phobia. I’m just going to call it needle phobia because I’m a simple-minded person.

The needle phobia is massive. I think there’s a definite fear of the needle, but there’s also a fear of failure. As soon as an injection is mentioned, many patients feel they failed miserably. There’s an emotional roller coaster that happens.

I’m sure, Dr. Jain, you have seen many patients, especially from Asia, who would say: “Oh, my auntie got on insulin and 3 months later, she got a kidney transplant.” “My uncle started on insulin and he unfortunately passed away a couple of months later.” Unfortunately, they’re blaming many of those things on insulin.

I also have a number of patients who said they were on insulin before many years ago, and they experienced some severe hypoglycemic events, and they don’t want to get on the insulin ever again. This is unfortunate because you know that if those patients, those aunties and uncles, were on insulin long before, maybe we could have saved their legs and kidneys, and potentially death.

Now we have advanced so much with insulin that hypoglycemia does occur, but much less than before. We still have many barriers when it comes to insulin initiations. Therefore, having this idea of inhaled insulin is fantastic, and I think we can get many more patients on insulin — the medication they actually need.

Dr. Jain: Absolutely. From the studies on inhaled insulin at ADA 2024, the key thing I found very interesting, regarding the pharmacokinetics of the insulin, was that it’s working very quickly. It starts working within minutes of administering it.

Additionally, it lasts in the body only for a shorter duration of time, compared with other injectable short-acting insulins, so it lasts in the body. The active insulin time is roughly about 2 hours or so, based on the studies, which in my mind opens up a whole world of possibilities because it means that people can take another correctional insulin if the blood sugars are still high after taking their first inhaled dose. You can take another dose subsequently without worrying about stacking of insulin. 

Many of us are familiar with this term, which is if you take two shots of short-acting insulin too close to each other, the insulin doses might add up and there can be a big drop in the blood sugars; it’s called stacking of insulin. This can be potentially avoided. 

Similarly, if you take your dinnertime inhaled insulin and the sugars are still high around bedtime, you could take a smaller dose of the inhaled insulin and not worry about middle-of-the-night hypoglycemia because the effect of the insulin would be only for a little while.

That’s one key learning that I found very helpful. The other important thing that I found was that this is not for everyone, so there are some restrictions. Essentially, the contraindication is that people who have asthma or COPD cannot be prescribed an inhaled insulin.

What are your thoughts, Dr. Kim, based on this for your practice in primary care? 

Dr. Kim: It is very fascinating, for sure. I cannot wait to get hold of this insulin. I can already think of some patients who may benefit. You’ve mentioned the asthma and COPD patients, and that makes more sense because there is an actual airway problem.

I also wonder what will happen to patients who have restrictive airway disease, where asthma and COPD fall under obstructive airway disease. What if they have obesity, where it’s really pressing into the diaphragm, and where they may not be able to take the deep breath in? How will they react?

What about someone who’s got a cold, someone who has postnasal drip, or someone who tends to cough frequently? What about egg allergies? There are many question marks around this insulin before initiating these medications. There is excitement, but there are also many questions at the same time.

Dr. Jain: I think these are very important, practical considerations that we’ll uncover as we start using more of this in clinical practice. The other important thing to note is that the presenters told us it’s important to monitor pulmonary function tests. It’s important to get a baseline pulmonary function test, and then we have to do another one in 6 months, followed by annually thereafter.

If, at any point of time, the FEV1 drops by 20% or more, then that would be an indication for discontinuation of the inhaled insulin. The pulmonary function test does not need to be one of those fancier ones. The study group would just do office spirometries. I’m wondering, Dr. Kim, in primary care, do you think this could potentially be a rate-limiting factor?

Dr. Kim: In Alberta, where I reside, no. Spirometry is very easily accessible in the province. For example, in Calgary alone, we have a population of about 1.3 million people. We have over 13 or 15 companies that can do this spirometry. We can get these things done literally within a week or 2.

However, I am aware that, in other provinces in Canada, it can definitely be a huge rate-limiting factor. Not everyone has the office-based spirometry, and definitely not within the primary care office. It has to be referred out to these private companies, most likely, and some of the rural areas will have to rely on the provincial hospitals, where the access can be even more challenging. 

On the day of the actual spirometry, if the person has a cough or is not feeling well, it’s going to be a problem because you don’t want the spirometry to be infected with a whole bunch of viruses. You’ll have to cancel that and it can be a bit of an issue.

Dr. Jain: Many of our viewers are from the United States and other parts of the world, and spirometry is quite easily accessible in most places. As an endocrinologist, I must confess that it’s been a long time since I’ve even ordered a spirometry or any clinical form of pulmonary function test. Once I start using the inhaled insulin, I’ll need to start brushing up on my pulmonary function test knowledge. 

I think these are exciting times. At least we’ve got something to offer to people who would have otherwise not taken any insulin at all. There’s certainly that hope that now there’s a different way to administer this, and hopefully it can only get better from here on.
 

Dr. Jain is a clinical instructor, Department of Endocrinology, University of British Columbia, Vancouver. Dr. Kim is a clinical assistant professor, Department of Family Medicine, University of Calgary in Alberta. Both disclosed conflicts of interest with numerous pharmaceutical companies.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity. 

Akshay B. Jain, MD: I’m Dr. Akshay Jain, an endocrinologist from Vancouver, and I’m joined by Dr. James Kim, a primary care physician from Calgary, Canada. 

Both Dr. Kim and I attended ADA 2024. We went over all our learnings and decided that there was a whole heap of clinical pearls that we learned from the conference. We thought it would be awesome if we could share our learnings with all of you, both from a primary care lens and from an endocrinology perspective.

One study Dr. Kim and I learned about, and we think has some definite nuances in management of people living with diabetes, regards inhaled insulin. When we have patients in our clinic who have perhaps failed multiple oral agents or have very high blood sugars, we obviously want to consider starting them on insulin for type 2 diabetes.

Sometimes there is a significant barrier, which is related to the needles. There’s an actual term for this: trypanophobia — a fear of needles. For the longest time, people have not wanted to take insulin or injectables because there’s only one way of administering it, which is subcutaneous.

Enter now inhaled insulin. We saw studies at the ADA 2024 conference that looked at a new inhaled insulin called Afrezza. Afrezza essentially is a short-acting insulin, so it’s kind of like a prandial insulin derivative, where it can be inhaled by an individual and it will work for mealtime control of blood sugars.

Dr. Kim, in your practice, how often do you see people not wanting to take shots, and has this been a big barrier for you in starting insulin? 

James W. Kim, MBBCh, PgDip, MScCH: Thank you for having me. To answer your question, absolutely I encounter this on a weekly basis — and I’m not even an endocrinologist. I just have an interest in diabetes. There are a number of patients that I think will benefit massively with insulin but they’re needle-phobic. You taught me that word, but I can never pronounce it, so my apologies for not remembering that phobia. I’m just going to call it needle phobia because I’m a simple-minded person.

The needle phobia is massive. I think there’s a definite fear of the needle, but there’s also a fear of failure. As soon as an injection is mentioned, many patients feel they failed miserably. There’s an emotional roller coaster that happens.

I’m sure, Dr. Jain, you have seen many patients, especially from Asia, who would say: “Oh, my auntie got on insulin and 3 months later, she got a kidney transplant.” “My uncle started on insulin and he unfortunately passed away a couple of months later.” Unfortunately, they’re blaming many of those things on insulin.

I also have a number of patients who said they were on insulin before many years ago, and they experienced some severe hypoglycemic events, and they don’t want to get on the insulin ever again. This is unfortunate because you know that if those patients, those aunties and uncles, were on insulin long before, maybe we could have saved their legs and kidneys, and potentially death.

Now we have advanced so much with insulin that hypoglycemia does occur, but much less than before. We still have many barriers when it comes to insulin initiations. Therefore, having this idea of inhaled insulin is fantastic, and I think we can get many more patients on insulin — the medication they actually need.

Dr. Jain: Absolutely. From the studies on inhaled insulin at ADA 2024, the key thing I found very interesting, regarding the pharmacokinetics of the insulin, was that it’s working very quickly. It starts working within minutes of administering it.

Additionally, it lasts in the body only for a shorter duration of time, compared with other injectable short-acting insulins, so it lasts in the body. The active insulin time is roughly about 2 hours or so, based on the studies, which in my mind opens up a whole world of possibilities because it means that people can take another correctional insulin if the blood sugars are still high after taking their first inhaled dose. You can take another dose subsequently without worrying about stacking of insulin. 

Many of us are familiar with this term, which is if you take two shots of short-acting insulin too close to each other, the insulin doses might add up and there can be a big drop in the blood sugars; it’s called stacking of insulin. This can be potentially avoided. 

Similarly, if you take your dinnertime inhaled insulin and the sugars are still high around bedtime, you could take a smaller dose of the inhaled insulin and not worry about middle-of-the-night hypoglycemia because the effect of the insulin would be only for a little while.

That’s one key learning that I found very helpful. The other important thing that I found was that this is not for everyone, so there are some restrictions. Essentially, the contraindication is that people who have asthma or COPD cannot be prescribed an inhaled insulin.

What are your thoughts, Dr. Kim, based on this for your practice in primary care? 

Dr. Kim: It is very fascinating, for sure. I cannot wait to get hold of this insulin. I can already think of some patients who may benefit. You’ve mentioned the asthma and COPD patients, and that makes more sense because there is an actual airway problem.

I also wonder what will happen to patients who have restrictive airway disease, where asthma and COPD fall under obstructive airway disease. What if they have obesity, where it’s really pressing into the diaphragm, and where they may not be able to take the deep breath in? How will they react?

What about someone who’s got a cold, someone who has postnasal drip, or someone who tends to cough frequently? What about egg allergies? There are many question marks around this insulin before initiating these medications. There is excitement, but there are also many questions at the same time.

Dr. Jain: I think these are very important, practical considerations that we’ll uncover as we start using more of this in clinical practice. The other important thing to note is that the presenters told us it’s important to monitor pulmonary function tests. It’s important to get a baseline pulmonary function test, and then we have to do another one in 6 months, followed by annually thereafter.

If, at any point of time, the FEV1 drops by 20% or more, then that would be an indication for discontinuation of the inhaled insulin. The pulmonary function test does not need to be one of those fancier ones. The study group would just do office spirometries. I’m wondering, Dr. Kim, in primary care, do you think this could potentially be a rate-limiting factor?

Dr. Kim: In Alberta, where I reside, no. Spirometry is very easily accessible in the province. For example, in Calgary alone, we have a population of about 1.3 million people. We have over 13 or 15 companies that can do this spirometry. We can get these things done literally within a week or 2.

However, I am aware that, in other provinces in Canada, it can definitely be a huge rate-limiting factor. Not everyone has the office-based spirometry, and definitely not within the primary care office. It has to be referred out to these private companies, most likely, and some of the rural areas will have to rely on the provincial hospitals, where the access can be even more challenging. 

On the day of the actual spirometry, if the person has a cough or is not feeling well, it’s going to be a problem because you don’t want the spirometry to be infected with a whole bunch of viruses. You’ll have to cancel that and it can be a bit of an issue.

Dr. Jain: Many of our viewers are from the United States and other parts of the world, and spirometry is quite easily accessible in most places. As an endocrinologist, I must confess that it’s been a long time since I’ve even ordered a spirometry or any clinical form of pulmonary function test. Once I start using the inhaled insulin, I’ll need to start brushing up on my pulmonary function test knowledge. 

I think these are exciting times. At least we’ve got something to offer to people who would have otherwise not taken any insulin at all. There’s certainly that hope that now there’s a different way to administer this, and hopefully it can only get better from here on.
 

Dr. Jain is a clinical instructor, Department of Endocrinology, University of British Columbia, Vancouver. Dr. Kim is a clinical assistant professor, Department of Family Medicine, University of Calgary in Alberta. Both disclosed conflicts of interest with numerous pharmaceutical companies.

A version of this article first appeared on Medscape.com.

TOPLINE:

When starting a regular exercise program, the skeletal muscle of sedentary men and women with overweight and obesity differs in burning sugar and fatty acids, but regular training can lessen these differences and promote similar positive metabolic changes in both biological sexes.

METHODOLOGY:

• By stimulating skeletal muscle, exercise can help prevent muscle loss associated with weight loss and improve insulin sensitivity and glucose control in type 2 diabetes, but biological sex-based differences have been reported for many measures.
• This study of sedentary men and women evaluated the molecular differences in skeletal muscle in response to a training program.
• Researchers collected muscle biopsies from 16 women and nine men with overweight or obesity (average age, 30 years) at three time points — baseline, after the first exercise session, and after the last session at the end of training.
• Training involved 1 hour of moderate to intense endurance exercise under supervision (30 minutes cycling on an ergometer and 30 minutes walking on a treadmill) thrice a week for 8 weeks.
• The biopsies were profiled for patterns of three sets of omics data — DNA methylation for insight into genes switched on and off (epigenomics), RNA molecules transcribed from genes (transcriptomics), and proteins (proteomics).

TAKEAWAY:

• At baseline, sex-specific differences were observed most tellingly in 120 proteins and also in DNA methylation sites of 16,012 genes and in 1366 RNA transcripts.
• Men displayed a higher abundance of glycolysis-related proteins and other fast-twitch fiber–type proteins, which are involved in the processing of glucose, while women showed more proteins responsible for regulating fatty acid metabolism.
• The response to the first exercise session differed between men and women, with the cellular stress response upregulated predominantly in men.
• The 8-week exercise training mitigated these sex-specific differences in the skeletal muscle, leading to an upregulation of mitochondrial proteins responsible for substrate oxidation and ATP generation in both men and women.

IN PRACTICE:

“This is important because the increased capacity after exercise to use glucose and lipids for energy production is generally regarded as key to prevent type 2 diabetes,” study leader Professor Cora Weigert from the University of Tübingen, Germany, said in a news release from the meeting organizers. “While initial response of skeletal muscles to exercise differs between females and males, repeated exercise appears to cancel out these differences and trigger beneficial metabolic changes in both sexes,” she added.

SOURCE:

The study was led by Simon I. Dreher, PhD, Institute for Clinical Chemistry and Pathobiochemistry, Department for Diagnostic Laboratory Medicine, Tübingen, Germany. It was published on August 15, 2024, as an early release from the annual meeting of the European Association for the Study of Diabetes 2024, Madrid, September 9-13.

LIMITATIONS:

This abstract did not discuss any limitations.

DISCLOSURES:

The authors did not disclose any funding information. The authors declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

When starting a regular exercise program, the skeletal muscle of sedentary men and women with overweight and obesity differs in burning sugar and fatty acids, but regular training can lessen these differences and promote similar positive metabolic changes in both biological sexes.

METHODOLOGY:

• By stimulating skeletal muscle, exercise can help prevent muscle loss associated with weight loss and improve insulin sensitivity and glucose control in type 2 diabetes, but biological sex-based differences have been reported for many measures.
• This study of sedentary men and women evaluated the molecular differences in skeletal muscle in response to a training program.
• Researchers collected muscle biopsies from 16 women and nine men with overweight or obesity (average age, 30 years) at three time points — baseline, after the first exercise session, and after the last session at the end of training.
• Training involved 1 hour of moderate to intense endurance exercise under supervision (30 minutes cycling on an ergometer and 30 minutes walking on a treadmill) thrice a week for 8 weeks.
• The biopsies were profiled for patterns of three sets of omics data — DNA methylation for insight into genes switched on and off (epigenomics), RNA molecules transcribed from genes (transcriptomics), and proteins (proteomics).

TAKEAWAY:

• At baseline, sex-specific differences were observed most tellingly in 120 proteins and also in DNA methylation sites of 16,012 genes and in 1366 RNA transcripts.
• Men displayed a higher abundance of glycolysis-related proteins and other fast-twitch fiber–type proteins, which are involved in the processing of glucose, while women showed more proteins responsible for regulating fatty acid metabolism.
• The response to the first exercise session differed between men and women, with the cellular stress response upregulated predominantly in men.
• The 8-week exercise training mitigated these sex-specific differences in the skeletal muscle, leading to an upregulation of mitochondrial proteins responsible for substrate oxidation and ATP generation in both men and women.

IN PRACTICE:

“This is important because the increased capacity after exercise to use glucose and lipids for energy production is generally regarded as key to prevent type 2 diabetes,” study leader Professor Cora Weigert from the University of Tübingen, Germany, said in a news release from the meeting organizers. “While initial response of skeletal muscles to exercise differs between females and males, repeated exercise appears to cancel out these differences and trigger beneficial metabolic changes in both sexes,” she added.

SOURCE:

The study was led by Simon I. Dreher, PhD, Institute for Clinical Chemistry and Pathobiochemistry, Department for Diagnostic Laboratory Medicine, Tübingen, Germany. It was published on August 15, 2024, as an early release from the annual meeting of the European Association for the Study of Diabetes 2024, Madrid, September 9-13.

LIMITATIONS:

This abstract did not discuss any limitations.

DISCLOSURES:

The authors did not disclose any funding information. The authors declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

When starting a regular exercise program, the skeletal muscle of sedentary men and women with overweight and obesity differs in burning sugar and fatty acids, but regular training can lessen these differences and promote similar positive metabolic changes in both biological sexes.

METHODOLOGY:

• By stimulating skeletal muscle, exercise can help prevent muscle loss associated with weight loss and improve insulin sensitivity and glucose control in type 2 diabetes, but biological sex-based differences have been reported for many measures.
• This study of sedentary men and women evaluated the molecular differences in skeletal muscle in response to a training program.
• Researchers collected muscle biopsies from 16 women and nine men with overweight or obesity (average age, 30 years) at three time points — baseline, after the first exercise session, and after the last session at the end of training.
• Training involved 1 hour of moderate to intense endurance exercise under supervision (30 minutes cycling on an ergometer and 30 minutes walking on a treadmill) thrice a week for 8 weeks.
• The biopsies were profiled for patterns of three sets of omics data — DNA methylation for insight into genes switched on and off (epigenomics), RNA molecules transcribed from genes (transcriptomics), and proteins (proteomics).

TAKEAWAY:

• At baseline, sex-specific differences were observed most tellingly in 120 proteins and also in DNA methylation sites of 16,012 genes and in 1366 RNA transcripts.
• Men displayed a higher abundance of glycolysis-related proteins and other fast-twitch fiber–type proteins, which are involved in the processing of glucose, while women showed more proteins responsible for regulating fatty acid metabolism.
• The response to the first exercise session differed between men and women, with the cellular stress response upregulated predominantly in men.
• The 8-week exercise training mitigated these sex-specific differences in the skeletal muscle, leading to an upregulation of mitochondrial proteins responsible for substrate oxidation and ATP generation in both men and women.

IN PRACTICE:

“This is important because the increased capacity after exercise to use glucose and lipids for energy production is generally regarded as key to prevent type 2 diabetes,” study leader Professor Cora Weigert from the University of Tübingen, Germany, said in a news release from the meeting organizers. “While initial response of skeletal muscles to exercise differs between females and males, repeated exercise appears to cancel out these differences and trigger beneficial metabolic changes in both sexes,” she added.

SOURCE:

The study was led by Simon I. Dreher, PhD, Institute for Clinical Chemistry and Pathobiochemistry, Department for Diagnostic Laboratory Medicine, Tübingen, Germany. It was published on August 15, 2024, as an early release from the annual meeting of the European Association for the Study of Diabetes 2024, Madrid, September 9-13.

LIMITATIONS:

This abstract did not discuss any limitations.

DISCLOSURES:

The authors did not disclose any funding information. The authors declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.