Reproductive Endocrinology

TOPLINE:

Higher body mass index (BMI) in both partners is linked to lower fecundability and increased subfertility. Overweight and obesity in women are associated with higher odds of miscarriage.

METHODOLOGY:

• Researchers conducted a population-based prospective cohort study in Rotterdam, the Netherlands, from August 9, 2017, to July 1, 2021.
• A total of 3604 women and their partners were included, with follow-up until birth.
• BMI was measured in preconception or early pregnancy, and outcomes included fecundability, subfertility, and miscarriage.
• Fecundability was defined as the probability of conceiving within 1 month and subfertility as time to pregnancy or duration of actively pursuing pregnancy of more than 12 months or use of assisted reproductive technology.
• Miscarriage was defined as pregnancy loss before 22 weeks of gestation.

TAKEAWAY:

• Higher BMI in women and men was associated with lower fecundability: For every unit increase in BMI, fecundability decreased (women, 0.98; 95% CI, 0.97-0.99; men, 0.99; 95% CI, 0.98-1.00).
• Women with overweight (0.88; 95% CI, 0.80-0.98) and obesity (0.72; 95% CI, 0.63-0.82) had lower fecundability than women with normal weight.
• Overweight (1.35; 95% CI, 1.11-1.63) and obesity (1.67; 95% CI, 1.30-2.13) in women were associated with increased odds of subfertility.
• Obesity in men was associated with increased odds of subfertility (1.69; 95% CI, 1.24-2.31).

IN PRACTICE:

“We observed in this cohort study that BMI outside of the normal category in women and men was associated with lower fecundability, subfertility, and increased odds of miscarriage. Optimizing BMI from the preconception period onward in women and men might be an important strategy to improve fertility and pregnancy outcomes,” wrote the authors of the study.

SOURCE:

The study was led by Aline J. Boxem, MD, and Vincent W. V. Jaddoe, MD, PhD, The Generation R Study Group, Erasmus University Medical Centre in Rotterdam, the Netherlands. It was published online in JAMA Network Open.

LIMITATIONS:

The study’s generalizability may be affected by differences between included and excluded participants, who were younger and had a higher BMI. The accuracy of time-to-pregnancy duration may have been impacted by retrospectively answered questionnaires. Residual confounding might still be an issue due to the observational nature of the study.

DISCLOSURES:

Dr. Boxem and Dr. Jaddoe disclosed receiving grants from the Erasmus University Medical Centre, the Erasmus University Rotterdam, and the Netherlands Organisation for Health Research and Development. Additional disclosures are noted in the original article.

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:

Higher body mass index (BMI) in both partners is linked to lower fecundability and increased subfertility. Overweight and obesity in women are associated with higher odds of miscarriage.

METHODOLOGY:

• Researchers conducted a population-based prospective cohort study in Rotterdam, the Netherlands, from August 9, 2017, to July 1, 2021.
• A total of 3604 women and their partners were included, with follow-up until birth.
• BMI was measured in preconception or early pregnancy, and outcomes included fecundability, subfertility, and miscarriage.
• Fecundability was defined as the probability of conceiving within 1 month and subfertility as time to pregnancy or duration of actively pursuing pregnancy of more than 12 months or use of assisted reproductive technology.
• Miscarriage was defined as pregnancy loss before 22 weeks of gestation.

TAKEAWAY:

• Higher BMI in women and men was associated with lower fecundability: For every unit increase in BMI, fecundability decreased (women, 0.98; 95% CI, 0.97-0.99; men, 0.99; 95% CI, 0.98-1.00).
• Women with overweight (0.88; 95% CI, 0.80-0.98) and obesity (0.72; 95% CI, 0.63-0.82) had lower fecundability than women with normal weight.
• Overweight (1.35; 95% CI, 1.11-1.63) and obesity (1.67; 95% CI, 1.30-2.13) in women were associated with increased odds of subfertility.
• Obesity in men was associated with increased odds of subfertility (1.69; 95% CI, 1.24-2.31).

IN PRACTICE:

“We observed in this cohort study that BMI outside of the normal category in women and men was associated with lower fecundability, subfertility, and increased odds of miscarriage. Optimizing BMI from the preconception period onward in women and men might be an important strategy to improve fertility and pregnancy outcomes,” wrote the authors of the study.

SOURCE:

The study was led by Aline J. Boxem, MD, and Vincent W. V. Jaddoe, MD, PhD, The Generation R Study Group, Erasmus University Medical Centre in Rotterdam, the Netherlands. It was published online in JAMA Network Open.

LIMITATIONS:

The study’s generalizability may be affected by differences between included and excluded participants, who were younger and had a higher BMI. The accuracy of time-to-pregnancy duration may have been impacted by retrospectively answered questionnaires. Residual confounding might still be an issue due to the observational nature of the study.

DISCLOSURES:

Dr. Boxem and Dr. Jaddoe disclosed receiving grants from the Erasmus University Medical Centre, the Erasmus University Rotterdam, and the Netherlands Organisation for Health Research and Development. Additional disclosures are noted in the original article.

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:

Higher body mass index (BMI) in both partners is linked to lower fecundability and increased subfertility. Overweight and obesity in women are associated with higher odds of miscarriage.

METHODOLOGY:

• Researchers conducted a population-based prospective cohort study in Rotterdam, the Netherlands, from August 9, 2017, to July 1, 2021.
• A total of 3604 women and their partners were included, with follow-up until birth.
• BMI was measured in preconception or early pregnancy, and outcomes included fecundability, subfertility, and miscarriage.
• Fecundability was defined as the probability of conceiving within 1 month and subfertility as time to pregnancy or duration of actively pursuing pregnancy of more than 12 months or use of assisted reproductive technology.
• Miscarriage was defined as pregnancy loss before 22 weeks of gestation.

TAKEAWAY:

• Higher BMI in women and men was associated with lower fecundability: For every unit increase in BMI, fecundability decreased (women, 0.98; 95% CI, 0.97-0.99; men, 0.99; 95% CI, 0.98-1.00).
• Women with overweight (0.88; 95% CI, 0.80-0.98) and obesity (0.72; 95% CI, 0.63-0.82) had lower fecundability than women with normal weight.
• Overweight (1.35; 95% CI, 1.11-1.63) and obesity (1.67; 95% CI, 1.30-2.13) in women were associated with increased odds of subfertility.
• Obesity in men was associated with increased odds of subfertility (1.69; 95% CI, 1.24-2.31).

IN PRACTICE:

“We observed in this cohort study that BMI outside of the normal category in women and men was associated with lower fecundability, subfertility, and increased odds of miscarriage. Optimizing BMI from the preconception period onward in women and men might be an important strategy to improve fertility and pregnancy outcomes,” wrote the authors of the study.

SOURCE:

The study was led by Aline J. Boxem, MD, and Vincent W. V. Jaddoe, MD, PhD, The Generation R Study Group, Erasmus University Medical Centre in Rotterdam, the Netherlands. It was published online in JAMA Network Open.

LIMITATIONS:

The study’s generalizability may be affected by differences between included and excluded participants, who were younger and had a higher BMI. The accuracy of time-to-pregnancy duration may have been impacted by retrospectively answered questionnaires. Residual confounding might still be an issue due to the observational nature of the study.

DISCLOSURES:

Dr. Boxem and Dr. Jaddoe disclosed receiving grants from the Erasmus University Medical Centre, the Erasmus University Rotterdam, and the Netherlands Organisation for Health Research and Development. Additional disclosures are noted in the original article.

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:

Long-term exposure to particulate matter < 2.5 μm in diameter (PM_2.5) is linked to a higher risk for infertility in men. Exposure to road traffic noise is associated with a higher risk for infertility in women aged > 35 years and possibly in men aged > 37 years.

METHODOLOGY:

• This nationwide prospective cohort study evaluated the association between long-term exposure to road traffic noise and PM_2.5 and infertility in 526,056 men (mean age, 33.6 years) and 377,850 women (mean age, 32.7 years) who were cohabiting or married, had fewer than two children, and lived in Denmark between 2000 and 2017.
• Residential exposure to road traffic noise (most exposed facade of the home) and PM_2.5 was estimated using validated models and linked to data from national registers.
• Diagnoses of infertility were identified in men and women from the Danish National Patient Register over a mean follow-up of 4.3 years and 4.2 years, respectively.

TAKEAWAY:

• Each 2.9 µg/m³ increase in the 5-year average exposure to PM_2.5 was associated with a 24% increase in the risk for infertility in men aged 30-45 years (adjusted hazard ratio [aHR], 1.24).
• No significant association was found between exposure to PM_2.5 and infertility in women.
• Each 10.2 dB increase in the 5-year average exposure to road traffic noise was associated with a 14% increase in infertility (aHR, 1.14; 95% CI, 1.10-1.18) in women aged 35-45 years.
• Exposure to noise was associated with a reduced risk for infertility in men aged 30.0-36.9 years (aHR, 0.93; 95% CI, 0.91-0.96) and an increased risk in those aged 37-45 years (aHR, 1.06; 95% CI, 1.02-1.11).

IN PRACTICE:

“As many Western countries are facing declining birth rates and increasing maternal age at the birth of a first child, knowledge on environmental pollutants affecting fertility is crucial,” the authors of the study wrote. “It suggests that political implementation of air pollution and noise mitigations may be important tools for improving birth rates in the Western world,” they added.

SOURCE:

The study, led by Mette Sorensen, of the Danish Cancer Institute in Copenhagen, Denmark, was published online in The BMJ.

LIMITATIONS:

The study’s reliance on register data meant information on lifestyle factors such as alcohol use, body mass index, and smoking was unavailable. The lack of data on exposure to noise and PM_2.5 at work and during leisure activities may affect the size and statistical precision of risk estimates.

DISCLOSURES:

The study did not receive any external funding. The authors declared no relevant conflicts of interest.

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

TOPLINE:

Long-term exposure to particulate matter < 2.5 μm in diameter (PM_2.5) is linked to a higher risk for infertility in men. Exposure to road traffic noise is associated with a higher risk for infertility in women aged > 35 years and possibly in men aged > 37 years.

METHODOLOGY:

• This nationwide prospective cohort study evaluated the association between long-term exposure to road traffic noise and PM_2.5 and infertility in 526,056 men (mean age, 33.6 years) and 377,850 women (mean age, 32.7 years) who were cohabiting or married, had fewer than two children, and lived in Denmark between 2000 and 2017.
• Residential exposure to road traffic noise (most exposed facade of the home) and PM_2.5 was estimated using validated models and linked to data from national registers.
• Diagnoses of infertility were identified in men and women from the Danish National Patient Register over a mean follow-up of 4.3 years and 4.2 years, respectively.

TAKEAWAY:

• Each 2.9 µg/m³ increase in the 5-year average exposure to PM_2.5 was associated with a 24% increase in the risk for infertility in men aged 30-45 years (adjusted hazard ratio [aHR], 1.24).
• No significant association was found between exposure to PM_2.5 and infertility in women.
• Each 10.2 dB increase in the 5-year average exposure to road traffic noise was associated with a 14% increase in infertility (aHR, 1.14; 95% CI, 1.10-1.18) in women aged 35-45 years.
• Exposure to noise was associated with a reduced risk for infertility in men aged 30.0-36.9 years (aHR, 0.93; 95% CI, 0.91-0.96) and an increased risk in those aged 37-45 years (aHR, 1.06; 95% CI, 1.02-1.11).

IN PRACTICE:

“As many Western countries are facing declining birth rates and increasing maternal age at the birth of a first child, knowledge on environmental pollutants affecting fertility is crucial,” the authors of the study wrote. “It suggests that political implementation of air pollution and noise mitigations may be important tools for improving birth rates in the Western world,” they added.

SOURCE:

The study, led by Mette Sorensen, of the Danish Cancer Institute in Copenhagen, Denmark, was published online in The BMJ.

LIMITATIONS:

The study’s reliance on register data meant information on lifestyle factors such as alcohol use, body mass index, and smoking was unavailable. The lack of data on exposure to noise and PM_2.5 at work and during leisure activities may affect the size and statistical precision of risk estimates.

DISCLOSURES:

The study did not receive any external funding. The authors declared no relevant conflicts of interest.

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

TOPLINE:

Long-term exposure to particulate matter < 2.5 μm in diameter (PM_2.5) is linked to a higher risk for infertility in men. Exposure to road traffic noise is associated with a higher risk for infertility in women aged > 35 years and possibly in men aged > 37 years.

METHODOLOGY:

• This nationwide prospective cohort study evaluated the association between long-term exposure to road traffic noise and PM_2.5 and infertility in 526,056 men (mean age, 33.6 years) and 377,850 women (mean age, 32.7 years) who were cohabiting or married, had fewer than two children, and lived in Denmark between 2000 and 2017.
• Residential exposure to road traffic noise (most exposed facade of the home) and PM_2.5 was estimated using validated models and linked to data from national registers.
• Diagnoses of infertility were identified in men and women from the Danish National Patient Register over a mean follow-up of 4.3 years and 4.2 years, respectively.

TAKEAWAY:

• Each 2.9 µg/m³ increase in the 5-year average exposure to PM_2.5 was associated with a 24% increase in the risk for infertility in men aged 30-45 years (adjusted hazard ratio [aHR], 1.24).
• No significant association was found between exposure to PM_2.5 and infertility in women.
• Each 10.2 dB increase in the 5-year average exposure to road traffic noise was associated with a 14% increase in infertility (aHR, 1.14; 95% CI, 1.10-1.18) in women aged 35-45 years.
• Exposure to noise was associated with a reduced risk for infertility in men aged 30.0-36.9 years (aHR, 0.93; 95% CI, 0.91-0.96) and an increased risk in those aged 37-45 years (aHR, 1.06; 95% CI, 1.02-1.11).

IN PRACTICE:

“As many Western countries are facing declining birth rates and increasing maternal age at the birth of a first child, knowledge on environmental pollutants affecting fertility is crucial,” the authors of the study wrote. “It suggests that political implementation of air pollution and noise mitigations may be important tools for improving birth rates in the Western world,” they added.

SOURCE:

The study, led by Mette Sorensen, of the Danish Cancer Institute in Copenhagen, Denmark, was published online in The BMJ.

LIMITATIONS:

The study’s reliance on register data meant information on lifestyle factors such as alcohol use, body mass index, and smoking was unavailable. The lack of data on exposure to noise and PM_2.5 at work and during leisure activities may affect the size and statistical precision of risk estimates.

DISCLOSURES:

The study did not receive any external funding. The authors declared no relevant conflicts of interest.

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

Childhood cancers represent a diverse group of neoplasms, and thanks to advances in treatment, survival rates have improved significantly. Today, more than 80%-85% of children diagnosed with cancer in developed countries survive into adulthood.

This increase in survival has brought new challenges, however. Compared with the general population, childhood cancer survivors (CCS) are at a notably higher risk for early mortality, developing secondary cancers, and experiencing various long-term clinical and psychosocial issues stemming from their disease or its treatment.

Long-term follow-up care for CCS is a complex and evolving field. Despite ongoing efforts to establish global and national guidelines, current evidence indicates that the care and management of these patients remain suboptimal.

Sexual dysfunction is a common and significant late effect among CCS. The disruptions caused by cancer and its treatment can interfere with normal physiological and psychological development, leading to issues with sexual function. This aspect of health is critical as it influences not just physical well-being but also psychosocial, developmental, and emotional health.
 

Characteristics and Mechanisms

Sexual functioning encompasses the physiological and psychological aspects of sexual behavior, including desire, arousal, orgasm, sexual pleasure, and overall satisfaction.

As CCS reach adolescence or adulthood, they often face sexual and reproductive issues, particularly as they enter romantic relationships.

Sexual functioning is a complex process that relies on the interaction of various factors, including physiological health, psychosexual development, romantic relationships, body image, and desire.

Despite its importance, the impact of childhood cancer on sexual function is often overlooked, even though cancer and its treatments can have lifelong effects. 
 

Sexual Function in CCS

A recent review aimed to summarize the existing research on sexual function among CCS, highlighting assessment tools, key stages of psychosexual development, common sexual problems, and the prevalence of sexual dysfunction.

The review study included 22 studies published between 2000 and 2022, comprising two qualitative, six cohort, and 14 cross-sectional studies.

Most CCS reached all key stages of psychosexual development at an average age of 29.8 years. Although some milestones were achieved later than is typical, many survivors felt they reached these stages at the appropriate time. Sexual initiation was less common among those who had undergone intensive neurotoxic treatments, such as those diagnosed with brain tumors or leukemia in childhood.

In a cross-sectional study of CCS aged 17-39 years, about one third had never engaged in sexual intercourse, 41.4% reported never experiencing sexual attraction, 44.8% were dissatisfied with their sex lives, and many rarely felt sexually attractive to others. Another study found that common issues among CCS included a lack of interest in sex (30%), difficulty enjoying sex (24%), and difficulty becoming aroused (23%). However, comparing and analyzing these problems was challenging due to the lack of standardized assessment criteria.

The prevalence of sexual dysfunction among CCS ranged from 12.3% to 46.5%. For males, the prevalence ranged from 12.3% to 54.0%, while for females, it ranged from 19.9% to 57.0%.
 

Factors Influencing Sexual Function

The review identified the following four categories of factors influencing sexual function in CCS: Demographic, treatment-related, psychological, and physiological.

Demographic factors: Gender, age, education level, relationship status, income level, and race all play roles in sexual function.

Female survivors reported more severe sexual dysfunction and poorer sexual health than did male survivors. Age at cancer diagnosis, age at evaluation, and the time since diagnosis were closely linked to sexual experiences. Patients diagnosed with cancer during childhood tended to report better sexual function than those diagnosed during adolescence.

Treatment-related factors: The type of cancer and intensity of treatment, along with surgical history, were significant factors. Surgeries involving the spinal cord or sympathetic nerves, as well as a history of prostate or pelvic surgery, were strongly associated with erectile dysfunction in men. In women, pelvic surgeries and treatments to the pelvic area were commonly linked to sexual dysfunction.

The association between treatment intensity and sexual function was noted across several studies, although the results were not always consistent. For example, testicular radiation above 10 Gy was positively correlated with sexual dysfunction. Women who underwent more intensive treatments were more likely to report issues in multiple areas of sexual function, while men in this group were less likely to have children.

Among female CCS, certain types of cancer, such as germ cell tumors, renal tumors, and leukemia, present a higher risk for sexual dysfunction. Women who had CNS tumors in childhood frequently reported problems like difficulty in sexual arousal, low sexual satisfaction, infrequent sexual activity, and fewer sexual partners, compared with survivors of other cancers. Survivors of acute lymphoblastic leukemia and those who underwent hematopoietic stem cell transplantation (HSCT) also showed varying degrees of impaired sexual function, compared with the general population. The HSCT group showed significant testicular damage, including reduced testicular volumes, low testosterone levels, and low sperm counts.

Psychological factors: These factors, such as emotional distress, play a significant role in sexual dysfunction among CCS. Symptoms like anxiety, nervousness during sexual activity, and depression are commonly reported by those with sexual dysfunction. The connection between body image and sexual function is complex. Many CCS with sexual dysfunction express concern about how others, particularly their partners, perceived their altered body image due to cancer and its treatment.

Physiological factors: In male CCS, low serum testosterone levels and low lean muscle mass are linked to an increased risk for sexual dysfunction. Treatments involving alkylating agents or testicular radiation, and surgery or radiotherapy targeting the genitourinary organs or the hypothalamic-pituitary region, can lead to various physiological and endocrine disorders, contributing to sexual dysfunction. Despite these risks, there is a lack of research evaluating sexual function through the lens of the hypothalamic-pituitary-gonadal axis and neuroendocrine pathways.
 

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

Childhood cancers represent a diverse group of neoplasms, and thanks to advances in treatment, survival rates have improved significantly. Today, more than 80%-85% of children diagnosed with cancer in developed countries survive into adulthood.

This increase in survival has brought new challenges, however. Compared with the general population, childhood cancer survivors (CCS) are at a notably higher risk for early mortality, developing secondary cancers, and experiencing various long-term clinical and psychosocial issues stemming from their disease or its treatment.

Long-term follow-up care for CCS is a complex and evolving field. Despite ongoing efforts to establish global and national guidelines, current evidence indicates that the care and management of these patients remain suboptimal.

Sexual dysfunction is a common and significant late effect among CCS. The disruptions caused by cancer and its treatment can interfere with normal physiological and psychological development, leading to issues with sexual function. This aspect of health is critical as it influences not just physical well-being but also psychosocial, developmental, and emotional health.
 

Characteristics and Mechanisms

Sexual functioning encompasses the physiological and psychological aspects of sexual behavior, including desire, arousal, orgasm, sexual pleasure, and overall satisfaction.

As CCS reach adolescence or adulthood, they often face sexual and reproductive issues, particularly as they enter romantic relationships.

Sexual functioning is a complex process that relies on the interaction of various factors, including physiological health, psychosexual development, romantic relationships, body image, and desire.

Despite its importance, the impact of childhood cancer on sexual function is often overlooked, even though cancer and its treatments can have lifelong effects. 
 

Sexual Function in CCS

A recent review aimed to summarize the existing research on sexual function among CCS, highlighting assessment tools, key stages of psychosexual development, common sexual problems, and the prevalence of sexual dysfunction.

The review study included 22 studies published between 2000 and 2022, comprising two qualitative, six cohort, and 14 cross-sectional studies.

Most CCS reached all key stages of psychosexual development at an average age of 29.8 years. Although some milestones were achieved later than is typical, many survivors felt they reached these stages at the appropriate time. Sexual initiation was less common among those who had undergone intensive neurotoxic treatments, such as those diagnosed with brain tumors or leukemia in childhood.

In a cross-sectional study of CCS aged 17-39 years, about one third had never engaged in sexual intercourse, 41.4% reported never experiencing sexual attraction, 44.8% were dissatisfied with their sex lives, and many rarely felt sexually attractive to others. Another study found that common issues among CCS included a lack of interest in sex (30%), difficulty enjoying sex (24%), and difficulty becoming aroused (23%). However, comparing and analyzing these problems was challenging due to the lack of standardized assessment criteria.

The prevalence of sexual dysfunction among CCS ranged from 12.3% to 46.5%. For males, the prevalence ranged from 12.3% to 54.0%, while for females, it ranged from 19.9% to 57.0%.
 

Factors Influencing Sexual Function

The review identified the following four categories of factors influencing sexual function in CCS: Demographic, treatment-related, psychological, and physiological.

Demographic factors: Gender, age, education level, relationship status, income level, and race all play roles in sexual function.

Female survivors reported more severe sexual dysfunction and poorer sexual health than did male survivors. Age at cancer diagnosis, age at evaluation, and the time since diagnosis were closely linked to sexual experiences. Patients diagnosed with cancer during childhood tended to report better sexual function than those diagnosed during adolescence.

Treatment-related factors: The type of cancer and intensity of treatment, along with surgical history, were significant factors. Surgeries involving the spinal cord or sympathetic nerves, as well as a history of prostate or pelvic surgery, were strongly associated with erectile dysfunction in men. In women, pelvic surgeries and treatments to the pelvic area were commonly linked to sexual dysfunction.

The association between treatment intensity and sexual function was noted across several studies, although the results were not always consistent. For example, testicular radiation above 10 Gy was positively correlated with sexual dysfunction. Women who underwent more intensive treatments were more likely to report issues in multiple areas of sexual function, while men in this group were less likely to have children.

Among female CCS, certain types of cancer, such as germ cell tumors, renal tumors, and leukemia, present a higher risk for sexual dysfunction. Women who had CNS tumors in childhood frequently reported problems like difficulty in sexual arousal, low sexual satisfaction, infrequent sexual activity, and fewer sexual partners, compared with survivors of other cancers. Survivors of acute lymphoblastic leukemia and those who underwent hematopoietic stem cell transplantation (HSCT) also showed varying degrees of impaired sexual function, compared with the general population. The HSCT group showed significant testicular damage, including reduced testicular volumes, low testosterone levels, and low sperm counts.

Psychological factors: These factors, such as emotional distress, play a significant role in sexual dysfunction among CCS. Symptoms like anxiety, nervousness during sexual activity, and depression are commonly reported by those with sexual dysfunction. The connection between body image and sexual function is complex. Many CCS with sexual dysfunction express concern about how others, particularly their partners, perceived their altered body image due to cancer and its treatment.

Physiological factors: In male CCS, low serum testosterone levels and low lean muscle mass are linked to an increased risk for sexual dysfunction. Treatments involving alkylating agents or testicular radiation, and surgery or radiotherapy targeting the genitourinary organs or the hypothalamic-pituitary region, can lead to various physiological and endocrine disorders, contributing to sexual dysfunction. Despite these risks, there is a lack of research evaluating sexual function through the lens of the hypothalamic-pituitary-gonadal axis and neuroendocrine pathways.
 

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

Childhood cancers represent a diverse group of neoplasms, and thanks to advances in treatment, survival rates have improved significantly. Today, more than 80%-85% of children diagnosed with cancer in developed countries survive into adulthood.

This increase in survival has brought new challenges, however. Compared with the general population, childhood cancer survivors (CCS) are at a notably higher risk for early mortality, developing secondary cancers, and experiencing various long-term clinical and psychosocial issues stemming from their disease or its treatment.

Long-term follow-up care for CCS is a complex and evolving field. Despite ongoing efforts to establish global and national guidelines, current evidence indicates that the care and management of these patients remain suboptimal.

Sexual dysfunction is a common and significant late effect among CCS. The disruptions caused by cancer and its treatment can interfere with normal physiological and psychological development, leading to issues with sexual function. This aspect of health is critical as it influences not just physical well-being but also psychosocial, developmental, and emotional health.
 

Characteristics and Mechanisms

Sexual functioning encompasses the physiological and psychological aspects of sexual behavior, including desire, arousal, orgasm, sexual pleasure, and overall satisfaction.

As CCS reach adolescence or adulthood, they often face sexual and reproductive issues, particularly as they enter romantic relationships.

Sexual functioning is a complex process that relies on the interaction of various factors, including physiological health, psychosexual development, romantic relationships, body image, and desire.

Despite its importance, the impact of childhood cancer on sexual function is often overlooked, even though cancer and its treatments can have lifelong effects. 
 

Sexual Function in CCS

A recent review aimed to summarize the existing research on sexual function among CCS, highlighting assessment tools, key stages of psychosexual development, common sexual problems, and the prevalence of sexual dysfunction.

The review study included 22 studies published between 2000 and 2022, comprising two qualitative, six cohort, and 14 cross-sectional studies.

Most CCS reached all key stages of psychosexual development at an average age of 29.8 years. Although some milestones were achieved later than is typical, many survivors felt they reached these stages at the appropriate time. Sexual initiation was less common among those who had undergone intensive neurotoxic treatments, such as those diagnosed with brain tumors or leukemia in childhood.

In a cross-sectional study of CCS aged 17-39 years, about one third had never engaged in sexual intercourse, 41.4% reported never experiencing sexual attraction, 44.8% were dissatisfied with their sex lives, and many rarely felt sexually attractive to others. Another study found that common issues among CCS included a lack of interest in sex (30%), difficulty enjoying sex (24%), and difficulty becoming aroused (23%). However, comparing and analyzing these problems was challenging due to the lack of standardized assessment criteria.

The prevalence of sexual dysfunction among CCS ranged from 12.3% to 46.5%. For males, the prevalence ranged from 12.3% to 54.0%, while for females, it ranged from 19.9% to 57.0%.
 

Factors Influencing Sexual Function

The review identified the following four categories of factors influencing sexual function in CCS: Demographic, treatment-related, psychological, and physiological.

Demographic factors: Gender, age, education level, relationship status, income level, and race all play roles in sexual function.

Female survivors reported more severe sexual dysfunction and poorer sexual health than did male survivors. Age at cancer diagnosis, age at evaluation, and the time since diagnosis were closely linked to sexual experiences. Patients diagnosed with cancer during childhood tended to report better sexual function than those diagnosed during adolescence.

Treatment-related factors: The type of cancer and intensity of treatment, along with surgical history, were significant factors. Surgeries involving the spinal cord or sympathetic nerves, as well as a history of prostate or pelvic surgery, were strongly associated with erectile dysfunction in men. In women, pelvic surgeries and treatments to the pelvic area were commonly linked to sexual dysfunction.

The association between treatment intensity and sexual function was noted across several studies, although the results were not always consistent. For example, testicular radiation above 10 Gy was positively correlated with sexual dysfunction. Women who underwent more intensive treatments were more likely to report issues in multiple areas of sexual function, while men in this group were less likely to have children.

Among female CCS, certain types of cancer, such as germ cell tumors, renal tumors, and leukemia, present a higher risk for sexual dysfunction. Women who had CNS tumors in childhood frequently reported problems like difficulty in sexual arousal, low sexual satisfaction, infrequent sexual activity, and fewer sexual partners, compared with survivors of other cancers. Survivors of acute lymphoblastic leukemia and those who underwent hematopoietic stem cell transplantation (HSCT) also showed varying degrees of impaired sexual function, compared with the general population. The HSCT group showed significant testicular damage, including reduced testicular volumes, low testosterone levels, and low sperm counts.

Psychological factors: These factors, such as emotional distress, play a significant role in sexual dysfunction among CCS. Symptoms like anxiety, nervousness during sexual activity, and depression are commonly reported by those with sexual dysfunction. The connection between body image and sexual function is complex. Many CCS with sexual dysfunction express concern about how others, particularly their partners, perceived their altered body image due to cancer and its treatment.

Physiological factors: In male CCS, low serum testosterone levels and low lean muscle mass are linked to an increased risk for sexual dysfunction. Treatments involving alkylating agents or testicular radiation, and surgery or radiotherapy targeting the genitourinary organs or the hypothalamic-pituitary region, can lead to various physiological and endocrine disorders, contributing to sexual dysfunction. Despite these risks, there is a lack of research evaluating sexual function through the lens of the hypothalamic-pituitary-gonadal axis and neuroendocrine pathways.
 

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

The allegations against Algerian boxer Imane Khelif at the Paris Olympics raised the questions of intersexuality and its implications in competitive sports. This news organization has decided to delve into the topic to assist doctors who suspect a similar condition in their patients. No certain clinical data about Ms. Khelif have been made public, so this article does not concern the boxer but rather takes inspiration from the media controversy.

What Is Intersexuality?

Intersexuality encompasses a spectrum of variations in sexual development that lead to the simultaneous presence of typical male and female characteristics. As reiterated by the United Nations Office of the High Commissioner for Human Rights, the medical definition does not affect the patient’s self-identification of gender or sexual orientation.

“The percentage of people who fall within the intersexuality spectrum is less than 0.5 per thousand of the general population, but there are no precise statistics, given the difficulty of definition,” said Roberto Lala, MD, pediatric endocrinologist and president of the Federation of Rare Childhood Diseases.

Indeed, there is not only a strict definition of intersexuality that involves a significant presence of these mixed physical characteristics in a way that conditions the self-image of the subject but also a broad definition, said Dr. Lala. “For example, clitoral hypertrophy in a female otherwise conforming to the female gender, which does not raise doubts about identity,” he said.
 

Chromosomes, Genes, and Hormones

A patient’s sexual characteristics are determined by the complex interaction of chromosomal, genetic, and hormonal factors. “The human body is, so to speak, programmed to take on female appearances in development and shifts toward male ones only if exposed to testosterone and other factors. For this to happen, testosterone must be produced during embryonic development, and it must function properly,” said Paolo Moghetti, full professor of endocrinology at the University of Verona, Italy.

The protein encoded by SRY, which is located on the Y chromosome, determines the development of the testicles from undifferentiated tissue of the embryonic gonads. The testicles of the embryo then produce testosterone. The absence of the Y chromosome is a common characteristic of most female individuals. However, there are individuals with a female phenotype who have X and Y chromosomes but lack SRY or have a variant of it that is not entirely functional.

Numerous other chromosomal or genetic variations can lead to alterations in sexual differentiation. “In phenotypically male adult subjects (with a chromosomal makeup of 46XY) with complete androgen insensitivity (so-called Morris syndrome), testosterone levels in the blood are elevated, above normal even for a male, but the hormone is totally ineffective, and the phenotype is totally female at birth, with completely female development of secondary sexual characteristics at puberty,” said Dr. Moghetti.

This means that affected individuals have well-developed breasts and a complete lack or extremely reduced presence of hair, including underarm and pubic hair. Menstruation is also completely absent because there is no uterus, and there are testes, not visible because they are considered in the abdomen.

“There are syndromes that are currently considered congenital but not genetic, of which a genetic origin will probably be identified in the future,” said Dr. Lala.

Some variations in sexual development can be diagnosed prenatally, such as an alteration of the number of sex chromosomes or a discordance between the morphologic characteristics highlighted by ultrasound and the genotype detected by amniocentesis. Some variations are evident at birth because of atypical anatomical characteristics. Others are diagnosed during puberty or later in adulthood, in the presence of infertility. The Italian National Institute of Health details these variations on its website, describing the characteristics that determine diagnosis and treatment.
 

Pathologies or Variations?

Some anomalies in sexual development negatively affect the patient’s physical health. One example is congenital adrenal hyperplasia. “It results from an inherited defect of the adrenal glands, which reduces cortisol production while increasing testosterone production,” said Dr. Lala. “In addition to the appearance of male characteristics in females, in more severe forms, it carries the risk of collapse and shock and requires pharmacological treatment.” It is undoubtedly a pathology.

Other variations in sexual characteristics do not affect the patient’s physical health negatively. They may, however, have a psychologic effect, sometimes a significant one, because of the lack of social acceptance of a person who cannot be classified within the binary classification of sexes.

“Conditions in which mixed male and female aspects are clearly evident have been and are still pathologized by the family, the treating physician, and society,” said Dr. Lala. “In the late 1970s, when a child was born with intersexual anatomical characteristics, it was common practice to surgically intervene, making them female, because it was technically easier.”

Over the years, patients who, as they grew up, were dissatisfied with the solution adopted at birth began to make their voices heard, Dr. Lala added. Scientific societies and international organizations have spoken out against subjecting intersexual newborns to surgical interventions that are not medically necessary. “Nowadays, decisions are made on a case-by-case basis, taking into account the families’ wishes. Interventions are justified with medical reasons, which are often very nuanced,” Dr. Lala concluded.
 

Implications for Sports

Traditionally, athletes participating in competitions in certain sports have been divided into male and female categories to ensure a certain equity and uniformity in performance. Over the years, the emergence of new information about sexual development has made it necessary to update the criteria used in this division.

The main factor responsible for the performance diversity between males and females is the action of testosterone on the male and female organism. “Testosterone has important effects on muscle mass and enhances training results,” said Dr. Moghetti. “As a demonstration of this fact, before puberty, the best performances in athletics or swimming by males and females are similar, then males gain a significant advantage of around 10%-20%.”

A few years ago, the World Athletics Federation conducted widespread screening of athletes participating in its world championships. “It identified a small group of individuals with potentially abnormal testosterone levels for the female sex,” said Dr. Moghetti. “Some were found to be doping, others had genetic defects, and for some, an interpretation was not even possible.”

Some of the individuals had a male genotype but a defect in 5-alpha-reductase, an enzyme essential for the formation of male genitals and hair growth. An athlete with these characteristics, assigned female sex at birth, has a male level of testosterone that stimulates the accumulation of muscle mass, Dr. Moghetti explained. Therefore, the individual has a considerable advantage in performances influenced by this hormone.

“In the end, the Federation decided to set limits on the testosterone levels of athletes participating in certain types of races, especially those in middle distance, that appeared to be more sensitive to differences in hormone levels,” said Dr. Moghetti. “The limitation does not apply to athletes with Morris syndrome, ie, with a male genotype and complete resistance to testosterone, for whom the high level of this hormone does not provide any advantage.” Given the complexity of the problem, he hopes for a case-by-case policy that considers the needs of patients with genetic alterations and those of athletes who have to compete with them.
 

Not the First Time

A recent incident underscored the difficulty of regulating such complex issues. The World Athletics Federation excluded South African middle-distance runner Caster Semenya from competitions years ago because of excessively high testosterone levels.

“The Federation’s regulations recommend that athletes in these cases reduce hormone levels to values below the threshold of 5 nmol/L of blood for a period of at least 6 months before the race by using hormonal contraceptives. The use of such drugs does not pose a health risk, as they are substances normally taken by women for contraception purposes,” said Amelia Filippelli, a pharmacologist at the University of Salerno in Italy. The South African middle-distance runner refused the drug and appealed to the Court of Arbitration for Sport and later to the Swiss Federal Court. Both rejected her appeal. Finally, Ms. Semenya appealed to the European Court of Human Rights, which in 2023 recognized a violation of her rights but does not have the authority to order a change in the Federation’s regulations.

Beyond the ideologic positions of nonexperts, therefore, the issue is still the subject of debate in the scientific community, which is evaluating not only its medical aspects but also its ethical implications.
 

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

The allegations against Algerian boxer Imane Khelif at the Paris Olympics raised the questions of intersexuality and its implications in competitive sports. This news organization has decided to delve into the topic to assist doctors who suspect a similar condition in their patients. No certain clinical data about Ms. Khelif have been made public, so this article does not concern the boxer but rather takes inspiration from the media controversy.

What Is Intersexuality?

Intersexuality encompasses a spectrum of variations in sexual development that lead to the simultaneous presence of typical male and female characteristics. As reiterated by the United Nations Office of the High Commissioner for Human Rights, the medical definition does not affect the patient’s self-identification of gender or sexual orientation.

“The percentage of people who fall within the intersexuality spectrum is less than 0.5 per thousand of the general population, but there are no precise statistics, given the difficulty of definition,” said Roberto Lala, MD, pediatric endocrinologist and president of the Federation of Rare Childhood Diseases.

Indeed, there is not only a strict definition of intersexuality that involves a significant presence of these mixed physical characteristics in a way that conditions the self-image of the subject but also a broad definition, said Dr. Lala. “For example, clitoral hypertrophy in a female otherwise conforming to the female gender, which does not raise doubts about identity,” he said.
 

Chromosomes, Genes, and Hormones

A patient’s sexual characteristics are determined by the complex interaction of chromosomal, genetic, and hormonal factors. “The human body is, so to speak, programmed to take on female appearances in development and shifts toward male ones only if exposed to testosterone and other factors. For this to happen, testosterone must be produced during embryonic development, and it must function properly,” said Paolo Moghetti, full professor of endocrinology at the University of Verona, Italy.

The protein encoded by SRY, which is located on the Y chromosome, determines the development of the testicles from undifferentiated tissue of the embryonic gonads. The testicles of the embryo then produce testosterone. The absence of the Y chromosome is a common characteristic of most female individuals. However, there are individuals with a female phenotype who have X and Y chromosomes but lack SRY or have a variant of it that is not entirely functional.

Numerous other chromosomal or genetic variations can lead to alterations in sexual differentiation. “In phenotypically male adult subjects (with a chromosomal makeup of 46XY) with complete androgen insensitivity (so-called Morris syndrome), testosterone levels in the blood are elevated, above normal even for a male, but the hormone is totally ineffective, and the phenotype is totally female at birth, with completely female development of secondary sexual characteristics at puberty,” said Dr. Moghetti.

This means that affected individuals have well-developed breasts and a complete lack or extremely reduced presence of hair, including underarm and pubic hair. Menstruation is also completely absent because there is no uterus, and there are testes, not visible because they are considered in the abdomen.

“There are syndromes that are currently considered congenital but not genetic, of which a genetic origin will probably be identified in the future,” said Dr. Lala.

Some variations in sexual development can be diagnosed prenatally, such as an alteration of the number of sex chromosomes or a discordance between the morphologic characteristics highlighted by ultrasound and the genotype detected by amniocentesis. Some variations are evident at birth because of atypical anatomical characteristics. Others are diagnosed during puberty or later in adulthood, in the presence of infertility. The Italian National Institute of Health details these variations on its website, describing the characteristics that determine diagnosis and treatment.
 

Pathologies or Variations?

Some anomalies in sexual development negatively affect the patient’s physical health. One example is congenital adrenal hyperplasia. “It results from an inherited defect of the adrenal glands, which reduces cortisol production while increasing testosterone production,” said Dr. Lala. “In addition to the appearance of male characteristics in females, in more severe forms, it carries the risk of collapse and shock and requires pharmacological treatment.” It is undoubtedly a pathology.

Other variations in sexual characteristics do not affect the patient’s physical health negatively. They may, however, have a psychologic effect, sometimes a significant one, because of the lack of social acceptance of a person who cannot be classified within the binary classification of sexes.

“Conditions in which mixed male and female aspects are clearly evident have been and are still pathologized by the family, the treating physician, and society,” said Dr. Lala. “In the late 1970s, when a child was born with intersexual anatomical characteristics, it was common practice to surgically intervene, making them female, because it was technically easier.”

Over the years, patients who, as they grew up, were dissatisfied with the solution adopted at birth began to make their voices heard, Dr. Lala added. Scientific societies and international organizations have spoken out against subjecting intersexual newborns to surgical interventions that are not medically necessary. “Nowadays, decisions are made on a case-by-case basis, taking into account the families’ wishes. Interventions are justified with medical reasons, which are often very nuanced,” Dr. Lala concluded.
 

Implications for Sports

Traditionally, athletes participating in competitions in certain sports have been divided into male and female categories to ensure a certain equity and uniformity in performance. Over the years, the emergence of new information about sexual development has made it necessary to update the criteria used in this division.

The main factor responsible for the performance diversity between males and females is the action of testosterone on the male and female organism. “Testosterone has important effects on muscle mass and enhances training results,” said Dr. Moghetti. “As a demonstration of this fact, before puberty, the best performances in athletics or swimming by males and females are similar, then males gain a significant advantage of around 10%-20%.”

A few years ago, the World Athletics Federation conducted widespread screening of athletes participating in its world championships. “It identified a small group of individuals with potentially abnormal testosterone levels for the female sex,” said Dr. Moghetti. “Some were found to be doping, others had genetic defects, and for some, an interpretation was not even possible.”

Some of the individuals had a male genotype but a defect in 5-alpha-reductase, an enzyme essential for the formation of male genitals and hair growth. An athlete with these characteristics, assigned female sex at birth, has a male level of testosterone that stimulates the accumulation of muscle mass, Dr. Moghetti explained. Therefore, the individual has a considerable advantage in performances influenced by this hormone.

“In the end, the Federation decided to set limits on the testosterone levels of athletes participating in certain types of races, especially those in middle distance, that appeared to be more sensitive to differences in hormone levels,” said Dr. Moghetti. “The limitation does not apply to athletes with Morris syndrome, ie, with a male genotype and complete resistance to testosterone, for whom the high level of this hormone does not provide any advantage.” Given the complexity of the problem, he hopes for a case-by-case policy that considers the needs of patients with genetic alterations and those of athletes who have to compete with them.
 

Not the First Time

A recent incident underscored the difficulty of regulating such complex issues. The World Athletics Federation excluded South African middle-distance runner Caster Semenya from competitions years ago because of excessively high testosterone levels.

“The Federation’s regulations recommend that athletes in these cases reduce hormone levels to values below the threshold of 5 nmol/L of blood for a period of at least 6 months before the race by using hormonal contraceptives. The use of such drugs does not pose a health risk, as they are substances normally taken by women for contraception purposes,” said Amelia Filippelli, a pharmacologist at the University of Salerno in Italy. The South African middle-distance runner refused the drug and appealed to the Court of Arbitration for Sport and later to the Swiss Federal Court. Both rejected her appeal. Finally, Ms. Semenya appealed to the European Court of Human Rights, which in 2023 recognized a violation of her rights but does not have the authority to order a change in the Federation’s regulations.

Beyond the ideologic positions of nonexperts, therefore, the issue is still the subject of debate in the scientific community, which is evaluating not only its medical aspects but also its ethical implications.
 

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

The allegations against Algerian boxer Imane Khelif at the Paris Olympics raised the questions of intersexuality and its implications in competitive sports. This news organization has decided to delve into the topic to assist doctors who suspect a similar condition in their patients. No certain clinical data about Ms. Khelif have been made public, so this article does not concern the boxer but rather takes inspiration from the media controversy.

What Is Intersexuality?

Intersexuality encompasses a spectrum of variations in sexual development that lead to the simultaneous presence of typical male and female characteristics. As reiterated by the United Nations Office of the High Commissioner for Human Rights, the medical definition does not affect the patient’s self-identification of gender or sexual orientation.

“The percentage of people who fall within the intersexuality spectrum is less than 0.5 per thousand of the general population, but there are no precise statistics, given the difficulty of definition,” said Roberto Lala, MD, pediatric endocrinologist and president of the Federation of Rare Childhood Diseases.

Indeed, there is not only a strict definition of intersexuality that involves a significant presence of these mixed physical characteristics in a way that conditions the self-image of the subject but also a broad definition, said Dr. Lala. “For example, clitoral hypertrophy in a female otherwise conforming to the female gender, which does not raise doubts about identity,” he said.
 

Chromosomes, Genes, and Hormones

A patient’s sexual characteristics are determined by the complex interaction of chromosomal, genetic, and hormonal factors. “The human body is, so to speak, programmed to take on female appearances in development and shifts toward male ones only if exposed to testosterone and other factors. For this to happen, testosterone must be produced during embryonic development, and it must function properly,” said Paolo Moghetti, full professor of endocrinology at the University of Verona, Italy.

The protein encoded by SRY, which is located on the Y chromosome, determines the development of the testicles from undifferentiated tissue of the embryonic gonads. The testicles of the embryo then produce testosterone. The absence of the Y chromosome is a common characteristic of most female individuals. However, there are individuals with a female phenotype who have X and Y chromosomes but lack SRY or have a variant of it that is not entirely functional.

Numerous other chromosomal or genetic variations can lead to alterations in sexual differentiation. “In phenotypically male adult subjects (with a chromosomal makeup of 46XY) with complete androgen insensitivity (so-called Morris syndrome), testosterone levels in the blood are elevated, above normal even for a male, but the hormone is totally ineffective, and the phenotype is totally female at birth, with completely female development of secondary sexual characteristics at puberty,” said Dr. Moghetti.

This means that affected individuals have well-developed breasts and a complete lack or extremely reduced presence of hair, including underarm and pubic hair. Menstruation is also completely absent because there is no uterus, and there are testes, not visible because they are considered in the abdomen.

“There are syndromes that are currently considered congenital but not genetic, of which a genetic origin will probably be identified in the future,” said Dr. Lala.

Some variations in sexual development can be diagnosed prenatally, such as an alteration of the number of sex chromosomes or a discordance between the morphologic characteristics highlighted by ultrasound and the genotype detected by amniocentesis. Some variations are evident at birth because of atypical anatomical characteristics. Others are diagnosed during puberty or later in adulthood, in the presence of infertility. The Italian National Institute of Health details these variations on its website, describing the characteristics that determine diagnosis and treatment.
 

Pathologies or Variations?

Some anomalies in sexual development negatively affect the patient’s physical health. One example is congenital adrenal hyperplasia. “It results from an inherited defect of the adrenal glands, which reduces cortisol production while increasing testosterone production,” said Dr. Lala. “In addition to the appearance of male characteristics in females, in more severe forms, it carries the risk of collapse and shock and requires pharmacological treatment.” It is undoubtedly a pathology.

Other variations in sexual characteristics do not affect the patient’s physical health negatively. They may, however, have a psychologic effect, sometimes a significant one, because of the lack of social acceptance of a person who cannot be classified within the binary classification of sexes.

“Conditions in which mixed male and female aspects are clearly evident have been and are still pathologized by the family, the treating physician, and society,” said Dr. Lala. “In the late 1970s, when a child was born with intersexual anatomical characteristics, it was common practice to surgically intervene, making them female, because it was technically easier.”

Over the years, patients who, as they grew up, were dissatisfied with the solution adopted at birth began to make their voices heard, Dr. Lala added. Scientific societies and international organizations have spoken out against subjecting intersexual newborns to surgical interventions that are not medically necessary. “Nowadays, decisions are made on a case-by-case basis, taking into account the families’ wishes. Interventions are justified with medical reasons, which are often very nuanced,” Dr. Lala concluded.
 

Implications for Sports

Traditionally, athletes participating in competitions in certain sports have been divided into male and female categories to ensure a certain equity and uniformity in performance. Over the years, the emergence of new information about sexual development has made it necessary to update the criteria used in this division.

The main factor responsible for the performance diversity between males and females is the action of testosterone on the male and female organism. “Testosterone has important effects on muscle mass and enhances training results,” said Dr. Moghetti. “As a demonstration of this fact, before puberty, the best performances in athletics or swimming by males and females are similar, then males gain a significant advantage of around 10%-20%.”

A few years ago, the World Athletics Federation conducted widespread screening of athletes participating in its world championships. “It identified a small group of individuals with potentially abnormal testosterone levels for the female sex,” said Dr. Moghetti. “Some were found to be doping, others had genetic defects, and for some, an interpretation was not even possible.”

Some of the individuals had a male genotype but a defect in 5-alpha-reductase, an enzyme essential for the formation of male genitals and hair growth. An athlete with these characteristics, assigned female sex at birth, has a male level of testosterone that stimulates the accumulation of muscle mass, Dr. Moghetti explained. Therefore, the individual has a considerable advantage in performances influenced by this hormone.

“In the end, the Federation decided to set limits on the testosterone levels of athletes participating in certain types of races, especially those in middle distance, that appeared to be more sensitive to differences in hormone levels,” said Dr. Moghetti. “The limitation does not apply to athletes with Morris syndrome, ie, with a male genotype and complete resistance to testosterone, for whom the high level of this hormone does not provide any advantage.” Given the complexity of the problem, he hopes for a case-by-case policy that considers the needs of patients with genetic alterations and those of athletes who have to compete with them.
 

Not the First Time

A recent incident underscored the difficulty of regulating such complex issues. The World Athletics Federation excluded South African middle-distance runner Caster Semenya from competitions years ago because of excessively high testosterone levels.

“The Federation’s regulations recommend that athletes in these cases reduce hormone levels to values below the threshold of 5 nmol/L of blood for a period of at least 6 months before the race by using hormonal contraceptives. The use of such drugs does not pose a health risk, as they are substances normally taken by women for contraception purposes,” said Amelia Filippelli, a pharmacologist at the University of Salerno in Italy. The South African middle-distance runner refused the drug and appealed to the Court of Arbitration for Sport and later to the Swiss Federal Court. Both rejected her appeal. Finally, Ms. Semenya appealed to the European Court of Human Rights, which in 2023 recognized a violation of her rights but does not have the authority to order a change in the Federation’s regulations.

Beyond the ideologic positions of nonexperts, therefore, the issue is still the subject of debate in the scientific community, which is evaluating not only its medical aspects but also its ethical implications.
 

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Women with polycystic ovary syndrome (PCOS) have higher odds of some eating disorders, including bulimia nervosa, binge eating disorder, and disordered eating, regardless of weight.

METHODOLOGY:

• A small systematic review and meta-analysis showed increased odds of any eating disorders and disordered eating scores in adult women with PCOS compared with women without PCOS.
• As part of the 2023 update of the International Evidence-based Guideline for the Assessment of and Management of PCOS, the same researchers updated and expanded their analysis to include adolescents and specific eating disorders and to evaluate the effect of body mass index (BMI) on these risks.
• They included 20 cross-sectional studies involving 28,922 women with PCOS and 258,619 women without PCOS; PCOS was diagnosed by either National Institutes of Health or Rotterdam criteria, as well as by patient self-report or hospital records.
• Eating disorders were screened using a validated disordered eating screening tool or diagnostic criteria from the Diagnostic and Statistical Manual of Mental Disorders.
• The outcomes of interest included the prevalence of any eating disorder, individual eating disorders, disordered eating, and mean disordered eating scores.

TAKEAWAY:

• Women with PCOS had 53% higher odds (odds ratio [OR], 1.53; 95% CI, 1.29-1.82; eight studies) of any eating disorder than control individuals without PCOS.
• The likelihood of bulimia nervosa (OR, 1.34; 95% CI, 1.17-1.54; five studies) and binge eating disorder (OR, 2.09; 95% CI, 1.18-3.72; four studies) was higher in women with PCOS, but no significant association was found for anorexia nervosa.
• The mean disordered eating scores and odds of disordered eating were higher in women with PCOS (standardized mean difference [SMD], 0.52; 95% CI, 0.28-0.77; 13 studies; and OR, 2.84; 95% CI, 1.0-8.04; eight studies; respectively).
• Disordered eating scores were higher in both the normal and higher weight categories (BMI < 25; SMD, 0.36; 95% CI, 0.15-0.58; five studies; and BMI ≥ 25; SMD, 0.68; 95% CI, 0.22-1.13; four studies; respectively).

IN PRACTICE:

“Our findings emphasize the importance of screening women with PCOS for eating disorders before clinicians share any lifestyle advice,” the lead author said in a press release. “The lifestyle modifications we often recommend for women with PCOS — including physical activity, healthy diet, and behavior modifications — could hinder the recovery process for eating disorders.”

SOURCE:

The study was led by Laura G. Cooney, MD, MSCE, University of Wisconsin, Madison, and published online in the Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The included studies were observational in nature, limiting the ability to adjust for potential confounders. The cross-sectional design of the included studies precluded determining whether the diagnosis of PCOS or the symptoms of disordered eating occurred first. Studies from 10 countries were included, but limited data from developing or Asian countries restrict the generalizability of the results.

DISCLOSURES:

This study was conducted to inform recommendations of the 2023 International Evidence-based Guideline in PCOS, which was funded by the Australian National Health and Medical Research Council, Centre for Research Excellence in Polycystic Ovary Syndrome, and other sources. The authors declared no conflicts of interests.

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:

Women with polycystic ovary syndrome (PCOS) have higher odds of some eating disorders, including bulimia nervosa, binge eating disorder, and disordered eating, regardless of weight.

METHODOLOGY:

• A small systematic review and meta-analysis showed increased odds of any eating disorders and disordered eating scores in adult women with PCOS compared with women without PCOS.
• As part of the 2023 update of the International Evidence-based Guideline for the Assessment of and Management of PCOS, the same researchers updated and expanded their analysis to include adolescents and specific eating disorders and to evaluate the effect of body mass index (BMI) on these risks.
• They included 20 cross-sectional studies involving 28,922 women with PCOS and 258,619 women without PCOS; PCOS was diagnosed by either National Institutes of Health or Rotterdam criteria, as well as by patient self-report or hospital records.
• Eating disorders were screened using a validated disordered eating screening tool or diagnostic criteria from the Diagnostic and Statistical Manual of Mental Disorders.
• The outcomes of interest included the prevalence of any eating disorder, individual eating disorders, disordered eating, and mean disordered eating scores.

TAKEAWAY:

• Women with PCOS had 53% higher odds (odds ratio [OR], 1.53; 95% CI, 1.29-1.82; eight studies) of any eating disorder than control individuals without PCOS.
• The likelihood of bulimia nervosa (OR, 1.34; 95% CI, 1.17-1.54; five studies) and binge eating disorder (OR, 2.09; 95% CI, 1.18-3.72; four studies) was higher in women with PCOS, but no significant association was found for anorexia nervosa.
• The mean disordered eating scores and odds of disordered eating were higher in women with PCOS (standardized mean difference [SMD], 0.52; 95% CI, 0.28-0.77; 13 studies; and OR, 2.84; 95% CI, 1.0-8.04; eight studies; respectively).
• Disordered eating scores were higher in both the normal and higher weight categories (BMI < 25; SMD, 0.36; 95% CI, 0.15-0.58; five studies; and BMI ≥ 25; SMD, 0.68; 95% CI, 0.22-1.13; four studies; respectively).

IN PRACTICE:

“Our findings emphasize the importance of screening women with PCOS for eating disorders before clinicians share any lifestyle advice,” the lead author said in a press release. “The lifestyle modifications we often recommend for women with PCOS — including physical activity, healthy diet, and behavior modifications — could hinder the recovery process for eating disorders.”

SOURCE:

The study was led by Laura G. Cooney, MD, MSCE, University of Wisconsin, Madison, and published online in the Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The included studies were observational in nature, limiting the ability to adjust for potential confounders. The cross-sectional design of the included studies precluded determining whether the diagnosis of PCOS or the symptoms of disordered eating occurred first. Studies from 10 countries were included, but limited data from developing or Asian countries restrict the generalizability of the results.

DISCLOSURES:

This study was conducted to inform recommendations of the 2023 International Evidence-based Guideline in PCOS, which was funded by the Australian National Health and Medical Research Council, Centre for Research Excellence in Polycystic Ovary Syndrome, and other sources. The authors declared no conflicts of interests.

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:

Women with polycystic ovary syndrome (PCOS) have higher odds of some eating disorders, including bulimia nervosa, binge eating disorder, and disordered eating, regardless of weight.

METHODOLOGY:

• A small systematic review and meta-analysis showed increased odds of any eating disorders and disordered eating scores in adult women with PCOS compared with women without PCOS.
• As part of the 2023 update of the International Evidence-based Guideline for the Assessment of and Management of PCOS, the same researchers updated and expanded their analysis to include adolescents and specific eating disorders and to evaluate the effect of body mass index (BMI) on these risks.
• They included 20 cross-sectional studies involving 28,922 women with PCOS and 258,619 women without PCOS; PCOS was diagnosed by either National Institutes of Health or Rotterdam criteria, as well as by patient self-report or hospital records.
• Eating disorders were screened using a validated disordered eating screening tool or diagnostic criteria from the Diagnostic and Statistical Manual of Mental Disorders.
• The outcomes of interest included the prevalence of any eating disorder, individual eating disorders, disordered eating, and mean disordered eating scores.

TAKEAWAY:

• Women with PCOS had 53% higher odds (odds ratio [OR], 1.53; 95% CI, 1.29-1.82; eight studies) of any eating disorder than control individuals without PCOS.
• The likelihood of bulimia nervosa (OR, 1.34; 95% CI, 1.17-1.54; five studies) and binge eating disorder (OR, 2.09; 95% CI, 1.18-3.72; four studies) was higher in women with PCOS, but no significant association was found for anorexia nervosa.
• The mean disordered eating scores and odds of disordered eating were higher in women with PCOS (standardized mean difference [SMD], 0.52; 95% CI, 0.28-0.77; 13 studies; and OR, 2.84; 95% CI, 1.0-8.04; eight studies; respectively).
• Disordered eating scores were higher in both the normal and higher weight categories (BMI < 25; SMD, 0.36; 95% CI, 0.15-0.58; five studies; and BMI ≥ 25; SMD, 0.68; 95% CI, 0.22-1.13; four studies; respectively).

IN PRACTICE:

“Our findings emphasize the importance of screening women with PCOS for eating disorders before clinicians share any lifestyle advice,” the lead author said in a press release. “The lifestyle modifications we often recommend for women with PCOS — including physical activity, healthy diet, and behavior modifications — could hinder the recovery process for eating disorders.”

SOURCE:

The study was led by Laura G. Cooney, MD, MSCE, University of Wisconsin, Madison, and published online in the Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The included studies were observational in nature, limiting the ability to adjust for potential confounders. The cross-sectional design of the included studies precluded determining whether the diagnosis of PCOS or the symptoms of disordered eating occurred first. Studies from 10 countries were included, but limited data from developing or Asian countries restrict the generalizability of the results.

DISCLOSURES:

This study was conducted to inform recommendations of the 2023 International Evidence-based Guideline in PCOS, which was funded by the Australian National Health and Medical Research Council, Centre for Research Excellence in Polycystic Ovary Syndrome, and other sources. The authors declared no conflicts of interests.

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:

Young and adult children of mothers with type 1 diabetes are almost half as likely be diagnosed with this condition compared with those with affected fathers, even with a similar genetic risk score. 

METHODOLOGY:

• Individuals with a family history of type 1 diabetes face 8-15 times higher risk for this condition than the general population, with the risk of inheritance from mothers with type 1 diabetes being about half that of fathers with type 1 diabetes; however, it is unclear if the effect continues past childhood and what is responsible for the difference in risk.
• Researchers performed a meta-analysis across five cohort studies involving 11,475 individuals diagnosed with type 1 diabetes aged 0-88 years to evaluate if maternal type 1 diabetes conferred relative protection only to young children.
• They compared the proportion of individuals with type 1 diabetes with affected fathers versus mothers and explored if this comparison was altered by the age at diagnosis and the timing of parental diagnosis relative to the birth of the offspring.
• Lastly, the inherited genetic risk for type 1 diabetes was compared between those with affected mothers versus fathers using a risk score composed of more than 60 different gene variants associated with type 1 diabetes.

TAKEAWAY:

• Individuals with type 1 diabetes were almost twice as likely to have a father with the condition than a mother (odds ratio, 1.79; P < .0001).
• The protective effect of maternal diabetes was seen regardless of whether the individuals were diagnosed with type 1 diabetes before or after age 18 years (P < .0001).
• Maternal diabetes was linked to a lower risk for type 1 diabetes in children only if the mother had type 1 diabetes during pregnancy.
• The genetic risk score for type 1 diabetes was not significantly different between those with affected fathers versus mothers (P = .31).

IN PRACTICE:

“Understanding why having a mother compared with a father with type 1 diabetes offers a relative protection against type 1 diabetes could help us develop new ways to prevent type 1 diabetes, such as treatments that mimic some of the protective elements from mothers,” study author Lowri Allen, MBChB, said in a news release.

SOURCE:

The study was led by Dr. Allen from the Diabetes Research Group, Cardiff University, Cardiff, Wales, and was published as an early release from the annual meeting of the European Association for the Study of Diabetes. 

LIMITATIONS:

This abstract did not discuss any limitations. The number of individuals and parents with type 1 diabetes in the meta-analysis was not disclosed. The baseline risk for type 1 diabetes among individuals with a mother, father, or both or no parent with type 1 diabetes was not disclosed. The number of people with type 1 diabetes under and over age 18 was not disclosed, nor were the numbers of mothers and fathers with type 1 diabetes. The relative risk in individuals having no parent with type 1 diabetes was not disclosed. Moreover, the race and ethnicity of the study populations were not disclosed. 

DISCLOSURES:

The Wellcome Trust supported this study. 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:

Young and adult children of mothers with type 1 diabetes are almost half as likely be diagnosed with this condition compared with those with affected fathers, even with a similar genetic risk score. 

METHODOLOGY:

• Individuals with a family history of type 1 diabetes face 8-15 times higher risk for this condition than the general population, with the risk of inheritance from mothers with type 1 diabetes being about half that of fathers with type 1 diabetes; however, it is unclear if the effect continues past childhood and what is responsible for the difference in risk.
• Researchers performed a meta-analysis across five cohort studies involving 11,475 individuals diagnosed with type 1 diabetes aged 0-88 years to evaluate if maternal type 1 diabetes conferred relative protection only to young children.
• They compared the proportion of individuals with type 1 diabetes with affected fathers versus mothers and explored if this comparison was altered by the age at diagnosis and the timing of parental diagnosis relative to the birth of the offspring.
• Lastly, the inherited genetic risk for type 1 diabetes was compared between those with affected mothers versus fathers using a risk score composed of more than 60 different gene variants associated with type 1 diabetes.

TAKEAWAY:

• Individuals with type 1 diabetes were almost twice as likely to have a father with the condition than a mother (odds ratio, 1.79; P < .0001).
• The protective effect of maternal diabetes was seen regardless of whether the individuals were diagnosed with type 1 diabetes before or after age 18 years (P < .0001).
• Maternal diabetes was linked to a lower risk for type 1 diabetes in children only if the mother had type 1 diabetes during pregnancy.
• The genetic risk score for type 1 diabetes was not significantly different between those with affected fathers versus mothers (P = .31).

IN PRACTICE:

“Understanding why having a mother compared with a father with type 1 diabetes offers a relative protection against type 1 diabetes could help us develop new ways to prevent type 1 diabetes, such as treatments that mimic some of the protective elements from mothers,” study author Lowri Allen, MBChB, said in a news release.

SOURCE:

The study was led by Dr. Allen from the Diabetes Research Group, Cardiff University, Cardiff, Wales, and was published as an early release from the annual meeting of the European Association for the Study of Diabetes. 

LIMITATIONS:

This abstract did not discuss any limitations. The number of individuals and parents with type 1 diabetes in the meta-analysis was not disclosed. The baseline risk for type 1 diabetes among individuals with a mother, father, or both or no parent with type 1 diabetes was not disclosed. The number of people with type 1 diabetes under and over age 18 was not disclosed, nor were the numbers of mothers and fathers with type 1 diabetes. The relative risk in individuals having no parent with type 1 diabetes was not disclosed. Moreover, the race and ethnicity of the study populations were not disclosed. 

DISCLOSURES:

The Wellcome Trust supported this study. 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:

Young and adult children of mothers with type 1 diabetes are almost half as likely be diagnosed with this condition compared with those with affected fathers, even with a similar genetic risk score. 

METHODOLOGY:

• Individuals with a family history of type 1 diabetes face 8-15 times higher risk for this condition than the general population, with the risk of inheritance from mothers with type 1 diabetes being about half that of fathers with type 1 diabetes; however, it is unclear if the effect continues past childhood and what is responsible for the difference in risk.
• Researchers performed a meta-analysis across five cohort studies involving 11,475 individuals diagnosed with type 1 diabetes aged 0-88 years to evaluate if maternal type 1 diabetes conferred relative protection only to young children.
• They compared the proportion of individuals with type 1 diabetes with affected fathers versus mothers and explored if this comparison was altered by the age at diagnosis and the timing of parental diagnosis relative to the birth of the offspring.
• Lastly, the inherited genetic risk for type 1 diabetes was compared between those with affected mothers versus fathers using a risk score composed of more than 60 different gene variants associated with type 1 diabetes.

TAKEAWAY:

• Individuals with type 1 diabetes were almost twice as likely to have a father with the condition than a mother (odds ratio, 1.79; P < .0001).
• The protective effect of maternal diabetes was seen regardless of whether the individuals were diagnosed with type 1 diabetes before or after age 18 years (P < .0001).
• Maternal diabetes was linked to a lower risk for type 1 diabetes in children only if the mother had type 1 diabetes during pregnancy.
• The genetic risk score for type 1 diabetes was not significantly different between those with affected fathers versus mothers (P = .31).

IN PRACTICE:

“Understanding why having a mother compared with a father with type 1 diabetes offers a relative protection against type 1 diabetes could help us develop new ways to prevent type 1 diabetes, such as treatments that mimic some of the protective elements from mothers,” study author Lowri Allen, MBChB, said in a news release.

SOURCE:

The study was led by Dr. Allen from the Diabetes Research Group, Cardiff University, Cardiff, Wales, and was published as an early release from the annual meeting of the European Association for the Study of Diabetes. 

LIMITATIONS:

This abstract did not discuss any limitations. The number of individuals and parents with type 1 diabetes in the meta-analysis was not disclosed. The baseline risk for type 1 diabetes among individuals with a mother, father, or both or no parent with type 1 diabetes was not disclosed. The number of people with type 1 diabetes under and over age 18 was not disclosed, nor were the numbers of mothers and fathers with type 1 diabetes. The relative risk in individuals having no parent with type 1 diabetes was not disclosed. Moreover, the race and ethnicity of the study populations were not disclosed. 

DISCLOSURES:

The Wellcome Trust supported this study. 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.

For 3 years, Ajala Efem’s type 2 diabetes was so poorly controlled that her blood sugar often soared northward of 500 mg/dL despite insulin shots three to five times a day. She would experience dizziness, vomiting, severe headaches, and the neuropathy in her feet made walking painful. She was also — literally — frothing at the mouth. The 47-year-old single mother of two adult children with mental disabilities feared that she would die.

Ms. Efem lives in the South Bronx, which is among the poorest areas of New York City, where the combined rate of prediabetes and diabetes is close to 30%, the highest rate of any borough in the city.

She had to wait 8 months for an appointment with an endocrinologist, but that visit proved to be life-changing. She lost 28 pounds and got off 15 medications in a single month. She did not join a gym or count calories; she simply changed the food she ate and adopted a low-carb diet.

“I went from being sick to feeling so great,” she told her endocrinologist recently: “My feet aren’t hurting; I’m not in pain; I’m eating as much as I want, and I really enjoy my food so much.” 

Ms. Efem’s life-changing visit was with Mariela Glandt, MD, at the offices of Essen Health Care. One month earlier, Dr. Glandt’s company, OwnaHealth, was contracted by Essen to conduct a 100-person pilot program for endocrinology patients. Essen is the largest Medicaid provider in New York City, and “they were desperate for an endocrinologist,” said Dr. Glandt, who trained at Columbia University in New York. So she came — all the way from Madrid, Spain. She commutes monthly, staying for a week each visit.

Dr. Glandt keeps up this punishing schedule because, as she explains, “it’s such a high for me to see these incredible transformations.” Her mostly Black and Hispanic patients are poor and lack resources, yet they lose significant amounts of weight, and their health issues resolve.

“Food is medicine” is an idea very much in vogue. The concept was central to the landmark White House Conference on Hunger, Nutrition, and Health in 2022 and is now the focus of a number of a wide range of government programs. Recently, the Senate held a hearing aimed at further expanding food as medicine programs.

Still, only a single randomized controlled clinical trial has been conducted on this nutritional approach, with unexpectedly disappointing results. In the mid-Atlantic region, 456 food-insecure adults with type 2 diabetes were randomly assigned to usual care or the provision of weekly groceries for their entire families for about 1 year. Provisions for a Mediterranean-style diet included whole grains, fruits and vegetables, lean protein, low-fat dairy products, cereal, brown rice, and bread. In addition, participants received dietary consultations. Yet, those who got free food and coaching did not see improvements in their average blood sugar (the study’s primary outcome), and their low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol levels appeared to have worsened. 

“To be honest, I was surprised,” the study’s lead author, Joseph Doyle, PhD, professor at the Sloan School of Management at MIT in Cambridge, Massachusetts, told me. “I was hoping we would show improved outcomes, but the way to make progress is to do well-randomized trials to find out what works.”

I was not surprised by these results because a recent rigorous systematic review and meta-analysis in The BMJ did not show a Mediterranean-style diet to be the most effective for glycemic control. And Ms. Efem was not in fact following a Mediterranean-style diet.

Ms. Efem’s low-carb success story is anecdotal, but Dr. Glandt has an established track record from her 9 years’ experience as the medical director of the eponymous diabetes center she founded in Tel Aviv. A recent audit of 344 patients from the center found that after 6 months of following a very low–carbohydrate diet, 96.3% of those with diabetes saw their A1c fall from a median 7.6% to 6.3%. Weight loss was significant, with a median drop of 6.5 kg (14 pounds) for patients with diabetes and 5.7 kg for those with prediabetes. The diet comprises 5%-10% of calories from carbs, but Dr. Glandt does not use numeric targets with her patients.

Blood pressure, triglycerides, and liver enzymes also improved. And though LDL cholesterol went up by 8%, this result may have been offset by an accompanying 13% rise in HDL cholesterol. Of the 78 patients initially on insulin, 62 were able to stop this medication entirely.

Although these results aren’t from a clinical trial, they’re still highly meaningful because the current dietary standard of care for type 2 diabetes can only slow the progression of the disease, not cause remission. Indeed, the idea that type 2 diabetes could be put into remission was not seriously considered by the American Diabetes Association (ADA) until 2009. By 2019, an ADA report concluded that “[r]educing overall carbohydrate intake for individuals with diabetes has demonstrated the most evidence for improving glycemia.” In other words, the best way to improve the key factor in diabetes is to reduce total carbohydrates. Yet, the ADA still advocates filling one quarter of one’s plate with carbohydrate-based foods, an amount that will prevent remission. Given that the ADA’s vision statement is “a life free of diabetes,” it seems negligent not to tell people with a deadly condition that they can reverse this diagnosis. 

A 2023 meta-analysis of 42 controlled clinical trials on 4809 patients showed that a very low–carbohydrate ketogenic diet (keto) was “superior” to alternatives for glycemic control. A more recent review of 11 clinical trials found that this diet was equal but not superior to other nutritional approaches in terms of blood sugar control, but this review also concluded that keto led to greater increases in HDL cholesterol and lower triglycerides. 

Dr. Glandt’s patients in the Bronx might not seem like obvious low-carb candidates. The diet is considered expensive and difficult to sustain. My interviews with a half dozen patients revealed some of these difficulties, but even for a woman living in a homeless shelter, the obstacles are not insurmountable.

Jerrilyn, who preferred that I use only her first name, lives in a shelter in Queens. While we strolled through a nearby park, she told me about her desire to lose weight and recover from polycystic ovary syndrome, which terrified her because it had caused dramatic hair loss. When she landed in Dr. Glandt’s office at age 28, she weighed 180 pounds. 

Less than 5 months later, Jerrilyn had lost 25 pounds, and her period had returned with some regularity. She said she used “food stamps,” known as the Supplemental Nutrition Assistance Program (SNAP), to buy most of her food at local delis because the meals served at the shelter were too heavy in starches. She starts her day with eggs, turkey bacon, and avocado. 

“It was hard to give up carbohydrates because in my culture [Latina], we have nothing but carbs: rice, potatoes, yuca,” Jerrilyn shared. She noticed that carbs make her hungrier, but after 3 days of going low-carb, her cravings diminished. “It was like getting over an addiction,” she said.

Jerrilyn told me she’d seen many doctors but none as involved as Dr. Glandt. “It feels awesome to know that I have a lot of really useful information coming from her all the time.” The OwnaHealth app tracks weight, blood pressure, blood sugar, ketones, meals, mood, and cravings. Patients wear continuous glucose monitors and enter other information manually. Ketone bodies are used to measure dietary adherence and are obtained through finger pricks and test strips provided by OwnaHealth. Dr. Glandt gives patients her own food plan, along with free visual guides to low-carbohydrate foods by dietdoctor.com. 

Dr. Glandt also sends her patients for regular blood work. She says she does not frequently see a rise in LDL cholesterol, which can sometimes occur on a low-carbohydrate diet. This effect is most common among people who are lean and fit. She says she doesn’t discontinue statins unless cholesterol levels improve significantly.

Samuel Gonzalez, age 56, weighed 275 pounds when he walked into Dr. Glandt’s office this past November. His A1c was 9.2%, but none of his previous doctors had diagnosed him with diabetes. “I was like a walking bag of sugar!” he joked. 

A low-carbohydrate diet seemed absurd to a Puerto Rican like himself: “Having coffee without sugar? That’s like sacrilegious in my culture!” exclaimed Mr. Gonzalez. Still, he managed, with SNAP, to cook eggs and bacon for breakfast and some kind of protein for dinner. He keeps lunch light, “like tuna fish,” and finds checking in with the OwnaHealth app to be very helpful. “Every day, I’m on it,” he said. In the past 7 months, he’s lost 50 pounds, normalized his cholesterol and blood pressure levels, and lowered his A1c to 5.5%.

Mr. Gonzalez gets disability payments due to a back injury, and Ms. Efem receives government payments because her husband died serving in the military. Ms. Efem says her new diet challenges her budget, but Mr. Gonzalez says he manages easily.

Mélissa Cruz, a 28-year-old studying to be a nail technician while also doing back office work at a physical therapy practice, says she’s stretched thin. “I end up sad because I can’t put energy into looking up recipes and cooking for me and my boyfriend,” she told me. She’ll often cook rice and plantains for him and meat for herself, but “it’s frustrating when I’m low on funds and can’t figure out what to eat.” 

Low-carbohydrate diets have a reputation for being expensive because people often start eating pricier foods, like meat and cheese, to replace cheaper starchy foods such as pasta and rice. Eggs and ground beef are less expensive low-carb meal options, and meat, unlike fruits and vegetables, is easy to freeze and doesn’t spoil quickly. These advantages can add up.

A 2019 cost analysis published in Nutrition & Dietetics compared a low-carbohydrate dietary pattern with the New Zealand government’s recommended guidelines (which are almost identical to those in the United States) and found that it cost only an extra $1.27 in US dollars per person per day. One explanation is that protein and fat are more satiating than carbohydrates, so people who mostly consume these macronutrients often cut back on snacks like packaged chips, crackers, and even fruits. Also, those on a ketogenic diet usually cut down on medications, so the additional $1.27 daily is likely offset by reduced spending at the pharmacy.

It’s not just Bronx residents with low socioeconomic status (SES) who adapt well to low-carbohydrate diets. Among Alabama state employees with diabetes enrolled in a low-carbohydrate dietary program provided by a company called Virta, the low SES population had the best outcomes. Virta also published survey data in 2023 showing that participants in a program with the Veteran’s Administration did not find additional costs to be an obstacle to dietary adherence. In fact, some participants saw cost reductions due to decreased spending on processed snacks and fast foods.

Ms. Cruz told me she struggles financially, yet she’s still lost nearly 30 pounds in 5 months, and her A1c went from 7.1% down to 5.9%, putting her diabetes into remission. Equally motivating for her are the improvements she’s seen in other hormonal issues. Since childhood, she’s had acanthosis, a condition that causes the skin to darken in velvety patches, and more recently, she developed severe hirsutism to the point of growing sideburns. “I had tried going vegan and fasting, but these just weren’t sustainable for me, and I was so overwhelmed with counting calories all the time.” Now, on a low-carbohydrate diet, which doesn’t require calorie counting, she’s finally seeing both these conditions improve significantly.

When I last checked in with Ms. Cruz, she said she had “kind of ghosted” Dr. Glandt due to her work and school constraints, but she hadn’t abandoned the diet. She appreciated, too, that Dr. Glandt had not given up on her and kept calling and messaging. “She’s not at all like a typical doctor who would just tell me to lose weight and shake their head at me,” Ms. Cruz said. 

Because Dr. Glandt’s approach is time-intensive and high-touch, it might seem impractical to scale up, but Dr. Glandt’s app uses artificial intelligence to help with communications thus allowing her, with help from part-time health coaches, to care for patients. 

This early success in one of the United States’ poorest and sickest neighborhoods should give us hope that type 2 diabetes need not to be a progressive irreversible disease, even among the disadvantaged. 

OwnaHealth’s track record, along with that of Virta and other similar low-carbohydrate medical practices also give hope to the food-is-medicine idea. Diabetes can go into remission, and people can be healed, provided that health practitioners prescribe the right foods. And in truth, it’s not a diet. It’s a way of eating that must be maintained. The sustainability of low-carbohydrate diets has been a point of contention, but the Virta trial, with 38% of patients sustaining remission at 2 years, showed that it’s possible. (OwnaHealth, for its part, offers long-term maintenance plans to help patients stay very low-carb permanently.) 

Given the tremendous costs and health burden of diabetes, this approach should no doubt be the first line of treatment for doctors and the ADA. The past two decades of clinical trial research have demonstrated that remission of type 2 diabetes is possible through diet alone. It turns out that for metabolic diseases, only certain foods are truly medicine. 
 

Tools and Tips for Clinicians: 

• Free two-page keto starter’s guide by OwnaHealth; Dr. Glandt uses this guide with her patients.
• Illustrated low-carb guides by dietdoctor.com
• Free low-carbohydrate starter guide by the Michigan Collaborative for Type 2 Diabetes
• Low-Carb for Any Budget, a free digital booklet by Mark Cucuzzella, MD, and Kristie Sullivan, PhD
• Recipe and meal ideas from Ruled.me, Keto-Mojo.com, and 

Dr. Teicholz is the founder of Nutrition Coalition, an independent nonprofit dedicated to ensuring that US dietary guidelines align with current science. She disclosed receiving book royalties from The Big Fat Surprise, and received honorarium not exceeding $2000 for speeches from various sources.

A version of this article appeared on Medscape.com.

For 3 years, Ajala Efem’s type 2 diabetes was so poorly controlled that her blood sugar often soared northward of 500 mg/dL despite insulin shots three to five times a day. She would experience dizziness, vomiting, severe headaches, and the neuropathy in her feet made walking painful. She was also — literally — frothing at the mouth. The 47-year-old single mother of two adult children with mental disabilities feared that she would die.

Ms. Efem lives in the South Bronx, which is among the poorest areas of New York City, where the combined rate of prediabetes and diabetes is close to 30%, the highest rate of any borough in the city.

She had to wait 8 months for an appointment with an endocrinologist, but that visit proved to be life-changing. She lost 28 pounds and got off 15 medications in a single month. She did not join a gym or count calories; she simply changed the food she ate and adopted a low-carb diet.

“I went from being sick to feeling so great,” she told her endocrinologist recently: “My feet aren’t hurting; I’m not in pain; I’m eating as much as I want, and I really enjoy my food so much.” 

Ms. Efem’s life-changing visit was with Mariela Glandt, MD, at the offices of Essen Health Care. One month earlier, Dr. Glandt’s company, OwnaHealth, was contracted by Essen to conduct a 100-person pilot program for endocrinology patients. Essen is the largest Medicaid provider in New York City, and “they were desperate for an endocrinologist,” said Dr. Glandt, who trained at Columbia University in New York. So she came — all the way from Madrid, Spain. She commutes monthly, staying for a week each visit.

Dr. Glandt keeps up this punishing schedule because, as she explains, “it’s such a high for me to see these incredible transformations.” Her mostly Black and Hispanic patients are poor and lack resources, yet they lose significant amounts of weight, and their health issues resolve.

“Food is medicine” is an idea very much in vogue. The concept was central to the landmark White House Conference on Hunger, Nutrition, and Health in 2022 and is now the focus of a number of a wide range of government programs. Recently, the Senate held a hearing aimed at further expanding food as medicine programs.

Still, only a single randomized controlled clinical trial has been conducted on this nutritional approach, with unexpectedly disappointing results. In the mid-Atlantic region, 456 food-insecure adults with type 2 diabetes were randomly assigned to usual care or the provision of weekly groceries for their entire families for about 1 year. Provisions for a Mediterranean-style diet included whole grains, fruits and vegetables, lean protein, low-fat dairy products, cereal, brown rice, and bread. In addition, participants received dietary consultations. Yet, those who got free food and coaching did not see improvements in their average blood sugar (the study’s primary outcome), and their low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol levels appeared to have worsened. 

“To be honest, I was surprised,” the study’s lead author, Joseph Doyle, PhD, professor at the Sloan School of Management at MIT in Cambridge, Massachusetts, told me. “I was hoping we would show improved outcomes, but the way to make progress is to do well-randomized trials to find out what works.”

I was not surprised by these results because a recent rigorous systematic review and meta-analysis in The BMJ did not show a Mediterranean-style diet to be the most effective for glycemic control. And Ms. Efem was not in fact following a Mediterranean-style diet.

Ms. Efem’s low-carb success story is anecdotal, but Dr. Glandt has an established track record from her 9 years’ experience as the medical director of the eponymous diabetes center she founded in Tel Aviv. A recent audit of 344 patients from the center found that after 6 months of following a very low–carbohydrate diet, 96.3% of those with diabetes saw their A1c fall from a median 7.6% to 6.3%. Weight loss was significant, with a median drop of 6.5 kg (14 pounds) for patients with diabetes and 5.7 kg for those with prediabetes. The diet comprises 5%-10% of calories from carbs, but Dr. Glandt does not use numeric targets with her patients.

Blood pressure, triglycerides, and liver enzymes also improved. And though LDL cholesterol went up by 8%, this result may have been offset by an accompanying 13% rise in HDL cholesterol. Of the 78 patients initially on insulin, 62 were able to stop this medication entirely.

Although these results aren’t from a clinical trial, they’re still highly meaningful because the current dietary standard of care for type 2 diabetes can only slow the progression of the disease, not cause remission. Indeed, the idea that type 2 diabetes could be put into remission was not seriously considered by the American Diabetes Association (ADA) until 2009. By 2019, an ADA report concluded that “[r]educing overall carbohydrate intake for individuals with diabetes has demonstrated the most evidence for improving glycemia.” In other words, the best way to improve the key factor in diabetes is to reduce total carbohydrates. Yet, the ADA still advocates filling one quarter of one’s plate with carbohydrate-based foods, an amount that will prevent remission. Given that the ADA’s vision statement is “a life free of diabetes,” it seems negligent not to tell people with a deadly condition that they can reverse this diagnosis. 

A 2023 meta-analysis of 42 controlled clinical trials on 4809 patients showed that a very low–carbohydrate ketogenic diet (keto) was “superior” to alternatives for glycemic control. A more recent review of 11 clinical trials found that this diet was equal but not superior to other nutritional approaches in terms of blood sugar control, but this review also concluded that keto led to greater increases in HDL cholesterol and lower triglycerides. 

Dr. Glandt’s patients in the Bronx might not seem like obvious low-carb candidates. The diet is considered expensive and difficult to sustain. My interviews with a half dozen patients revealed some of these difficulties, but even for a woman living in a homeless shelter, the obstacles are not insurmountable.

Jerrilyn, who preferred that I use only her first name, lives in a shelter in Queens. While we strolled through a nearby park, she told me about her desire to lose weight and recover from polycystic ovary syndrome, which terrified her because it had caused dramatic hair loss. When she landed in Dr. Glandt’s office at age 28, she weighed 180 pounds. 

Less than 5 months later, Jerrilyn had lost 25 pounds, and her period had returned with some regularity. She said she used “food stamps,” known as the Supplemental Nutrition Assistance Program (SNAP), to buy most of her food at local delis because the meals served at the shelter were too heavy in starches. She starts her day with eggs, turkey bacon, and avocado. 

“It was hard to give up carbohydrates because in my culture [Latina], we have nothing but carbs: rice, potatoes, yuca,” Jerrilyn shared. She noticed that carbs make her hungrier, but after 3 days of going low-carb, her cravings diminished. “It was like getting over an addiction,” she said.

Jerrilyn told me she’d seen many doctors but none as involved as Dr. Glandt. “It feels awesome to know that I have a lot of really useful information coming from her all the time.” The OwnaHealth app tracks weight, blood pressure, blood sugar, ketones, meals, mood, and cravings. Patients wear continuous glucose monitors and enter other information manually. Ketone bodies are used to measure dietary adherence and are obtained through finger pricks and test strips provided by OwnaHealth. Dr. Glandt gives patients her own food plan, along with free visual guides to low-carbohydrate foods by dietdoctor.com. 

Dr. Glandt also sends her patients for regular blood work. She says she does not frequently see a rise in LDL cholesterol, which can sometimes occur on a low-carbohydrate diet. This effect is most common among people who are lean and fit. She says she doesn’t discontinue statins unless cholesterol levels improve significantly.

Samuel Gonzalez, age 56, weighed 275 pounds when he walked into Dr. Glandt’s office this past November. His A1c was 9.2%, but none of his previous doctors had diagnosed him with diabetes. “I was like a walking bag of sugar!” he joked. 

A low-carbohydrate diet seemed absurd to a Puerto Rican like himself: “Having coffee without sugar? That’s like sacrilegious in my culture!” exclaimed Mr. Gonzalez. Still, he managed, with SNAP, to cook eggs and bacon for breakfast and some kind of protein for dinner. He keeps lunch light, “like tuna fish,” and finds checking in with the OwnaHealth app to be very helpful. “Every day, I’m on it,” he said. In the past 7 months, he’s lost 50 pounds, normalized his cholesterol and blood pressure levels, and lowered his A1c to 5.5%.

Mr. Gonzalez gets disability payments due to a back injury, and Ms. Efem receives government payments because her husband died serving in the military. Ms. Efem says her new diet challenges her budget, but Mr. Gonzalez says he manages easily.

Mélissa Cruz, a 28-year-old studying to be a nail technician while also doing back office work at a physical therapy practice, says she’s stretched thin. “I end up sad because I can’t put energy into looking up recipes and cooking for me and my boyfriend,” she told me. She’ll often cook rice and plantains for him and meat for herself, but “it’s frustrating when I’m low on funds and can’t figure out what to eat.” 

Low-carbohydrate diets have a reputation for being expensive because people often start eating pricier foods, like meat and cheese, to replace cheaper starchy foods such as pasta and rice. Eggs and ground beef are less expensive low-carb meal options, and meat, unlike fruits and vegetables, is easy to freeze and doesn’t spoil quickly. These advantages can add up.

A 2019 cost analysis published in Nutrition & Dietetics compared a low-carbohydrate dietary pattern with the New Zealand government’s recommended guidelines (which are almost identical to those in the United States) and found that it cost only an extra $1.27 in US dollars per person per day. One explanation is that protein and fat are more satiating than carbohydrates, so people who mostly consume these macronutrients often cut back on snacks like packaged chips, crackers, and even fruits. Also, those on a ketogenic diet usually cut down on medications, so the additional $1.27 daily is likely offset by reduced spending at the pharmacy.

It’s not just Bronx residents with low socioeconomic status (SES) who adapt well to low-carbohydrate diets. Among Alabama state employees with diabetes enrolled in a low-carbohydrate dietary program provided by a company called Virta, the low SES population had the best outcomes. Virta also published survey data in 2023 showing that participants in a program with the Veteran’s Administration did not find additional costs to be an obstacle to dietary adherence. In fact, some participants saw cost reductions due to decreased spending on processed snacks and fast foods.

Ms. Cruz told me she struggles financially, yet she’s still lost nearly 30 pounds in 5 months, and her A1c went from 7.1% down to 5.9%, putting her diabetes into remission. Equally motivating for her are the improvements she’s seen in other hormonal issues. Since childhood, she’s had acanthosis, a condition that causes the skin to darken in velvety patches, and more recently, she developed severe hirsutism to the point of growing sideburns. “I had tried going vegan and fasting, but these just weren’t sustainable for me, and I was so overwhelmed with counting calories all the time.” Now, on a low-carbohydrate diet, which doesn’t require calorie counting, she’s finally seeing both these conditions improve significantly.

When I last checked in with Ms. Cruz, she said she had “kind of ghosted” Dr. Glandt due to her work and school constraints, but she hadn’t abandoned the diet. She appreciated, too, that Dr. Glandt had not given up on her and kept calling and messaging. “She’s not at all like a typical doctor who would just tell me to lose weight and shake their head at me,” Ms. Cruz said. 

Because Dr. Glandt’s approach is time-intensive and high-touch, it might seem impractical to scale up, but Dr. Glandt’s app uses artificial intelligence to help with communications thus allowing her, with help from part-time health coaches, to care for patients. 

This early success in one of the United States’ poorest and sickest neighborhoods should give us hope that type 2 diabetes need not to be a progressive irreversible disease, even among the disadvantaged. 

OwnaHealth’s track record, along with that of Virta and other similar low-carbohydrate medical practices also give hope to the food-is-medicine idea. Diabetes can go into remission, and people can be healed, provided that health practitioners prescribe the right foods. And in truth, it’s not a diet. It’s a way of eating that must be maintained. The sustainability of low-carbohydrate diets has been a point of contention, but the Virta trial, with 38% of patients sustaining remission at 2 years, showed that it’s possible. (OwnaHealth, for its part, offers long-term maintenance plans to help patients stay very low-carb permanently.) 

Given the tremendous costs and health burden of diabetes, this approach should no doubt be the first line of treatment for doctors and the ADA. The past two decades of clinical trial research have demonstrated that remission of type 2 diabetes is possible through diet alone. It turns out that for metabolic diseases, only certain foods are truly medicine. 
 

Tools and Tips for Clinicians: 

• Free two-page keto starter’s guide by OwnaHealth; Dr. Glandt uses this guide with her patients.
• Illustrated low-carb guides by dietdoctor.com
• Free low-carbohydrate starter guide by the Michigan Collaborative for Type 2 Diabetes
• Low-Carb for Any Budget, a free digital booklet by Mark Cucuzzella, MD, and Kristie Sullivan, PhD
• Recipe and meal ideas from Ruled.me, Keto-Mojo.com, and 

Dr. Teicholz is the founder of Nutrition Coalition, an independent nonprofit dedicated to ensuring that US dietary guidelines align with current science. She disclosed receiving book royalties from The Big Fat Surprise, and received honorarium not exceeding $2000 for speeches from various sources.

A version of this article appeared on Medscape.com.

For 3 years, Ajala Efem’s type 2 diabetes was so poorly controlled that her blood sugar often soared northward of 500 mg/dL despite insulin shots three to five times a day. She would experience dizziness, vomiting, severe headaches, and the neuropathy in her feet made walking painful. She was also — literally — frothing at the mouth. The 47-year-old single mother of two adult children with mental disabilities feared that she would die.

Ms. Efem lives in the South Bronx, which is among the poorest areas of New York City, where the combined rate of prediabetes and diabetes is close to 30%, the highest rate of any borough in the city.

She had to wait 8 months for an appointment with an endocrinologist, but that visit proved to be life-changing. She lost 28 pounds and got off 15 medications in a single month. She did not join a gym or count calories; she simply changed the food she ate and adopted a low-carb diet.

“I went from being sick to feeling so great,” she told her endocrinologist recently: “My feet aren’t hurting; I’m not in pain; I’m eating as much as I want, and I really enjoy my food so much.” 

Ms. Efem’s life-changing visit was with Mariela Glandt, MD, at the offices of Essen Health Care. One month earlier, Dr. Glandt’s company, OwnaHealth, was contracted by Essen to conduct a 100-person pilot program for endocrinology patients. Essen is the largest Medicaid provider in New York City, and “they were desperate for an endocrinologist,” said Dr. Glandt, who trained at Columbia University in New York. So she came — all the way from Madrid, Spain. She commutes monthly, staying for a week each visit.

Dr. Glandt keeps up this punishing schedule because, as she explains, “it’s such a high for me to see these incredible transformations.” Her mostly Black and Hispanic patients are poor and lack resources, yet they lose significant amounts of weight, and their health issues resolve.

“Food is medicine” is an idea very much in vogue. The concept was central to the landmark White House Conference on Hunger, Nutrition, and Health in 2022 and is now the focus of a number of a wide range of government programs. Recently, the Senate held a hearing aimed at further expanding food as medicine programs.

Still, only a single randomized controlled clinical trial has been conducted on this nutritional approach, with unexpectedly disappointing results. In the mid-Atlantic region, 456 food-insecure adults with type 2 diabetes were randomly assigned to usual care or the provision of weekly groceries for their entire families for about 1 year. Provisions for a Mediterranean-style diet included whole grains, fruits and vegetables, lean protein, low-fat dairy products, cereal, brown rice, and bread. In addition, participants received dietary consultations. Yet, those who got free food and coaching did not see improvements in their average blood sugar (the study’s primary outcome), and their low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol levels appeared to have worsened. 

“To be honest, I was surprised,” the study’s lead author, Joseph Doyle, PhD, professor at the Sloan School of Management at MIT in Cambridge, Massachusetts, told me. “I was hoping we would show improved outcomes, but the way to make progress is to do well-randomized trials to find out what works.”

I was not surprised by these results because a recent rigorous systematic review and meta-analysis in The BMJ did not show a Mediterranean-style diet to be the most effective for glycemic control. And Ms. Efem was not in fact following a Mediterranean-style diet.

Ms. Efem’s low-carb success story is anecdotal, but Dr. Glandt has an established track record from her 9 years’ experience as the medical director of the eponymous diabetes center she founded in Tel Aviv. A recent audit of 344 patients from the center found that after 6 months of following a very low–carbohydrate diet, 96.3% of those with diabetes saw their A1c fall from a median 7.6% to 6.3%. Weight loss was significant, with a median drop of 6.5 kg (14 pounds) for patients with diabetes and 5.7 kg for those with prediabetes. The diet comprises 5%-10% of calories from carbs, but Dr. Glandt does not use numeric targets with her patients.

Blood pressure, triglycerides, and liver enzymes also improved. And though LDL cholesterol went up by 8%, this result may have been offset by an accompanying 13% rise in HDL cholesterol. Of the 78 patients initially on insulin, 62 were able to stop this medication entirely.

Although these results aren’t from a clinical trial, they’re still highly meaningful because the current dietary standard of care for type 2 diabetes can only slow the progression of the disease, not cause remission. Indeed, the idea that type 2 diabetes could be put into remission was not seriously considered by the American Diabetes Association (ADA) until 2009. By 2019, an ADA report concluded that “[r]educing overall carbohydrate intake for individuals with diabetes has demonstrated the most evidence for improving glycemia.” In other words, the best way to improve the key factor in diabetes is to reduce total carbohydrates. Yet, the ADA still advocates filling one quarter of one’s plate with carbohydrate-based foods, an amount that will prevent remission. Given that the ADA’s vision statement is “a life free of diabetes,” it seems negligent not to tell people with a deadly condition that they can reverse this diagnosis. 

A 2023 meta-analysis of 42 controlled clinical trials on 4809 patients showed that a very low–carbohydrate ketogenic diet (keto) was “superior” to alternatives for glycemic control. A more recent review of 11 clinical trials found that this diet was equal but not superior to other nutritional approaches in terms of blood sugar control, but this review also concluded that keto led to greater increases in HDL cholesterol and lower triglycerides. 

Dr. Glandt’s patients in the Bronx might not seem like obvious low-carb candidates. The diet is considered expensive and difficult to sustain. My interviews with a half dozen patients revealed some of these difficulties, but even for a woman living in a homeless shelter, the obstacles are not insurmountable.

Jerrilyn, who preferred that I use only her first name, lives in a shelter in Queens. While we strolled through a nearby park, she told me about her desire to lose weight and recover from polycystic ovary syndrome, which terrified her because it had caused dramatic hair loss. When she landed in Dr. Glandt’s office at age 28, she weighed 180 pounds. 

Less than 5 months later, Jerrilyn had lost 25 pounds, and her period had returned with some regularity. She said she used “food stamps,” known as the Supplemental Nutrition Assistance Program (SNAP), to buy most of her food at local delis because the meals served at the shelter were too heavy in starches. She starts her day with eggs, turkey bacon, and avocado. 

“It was hard to give up carbohydrates because in my culture [Latina], we have nothing but carbs: rice, potatoes, yuca,” Jerrilyn shared. She noticed that carbs make her hungrier, but after 3 days of going low-carb, her cravings diminished. “It was like getting over an addiction,” she said.

Jerrilyn told me she’d seen many doctors but none as involved as Dr. Glandt. “It feels awesome to know that I have a lot of really useful information coming from her all the time.” The OwnaHealth app tracks weight, blood pressure, blood sugar, ketones, meals, mood, and cravings. Patients wear continuous glucose monitors and enter other information manually. Ketone bodies are used to measure dietary adherence and are obtained through finger pricks and test strips provided by OwnaHealth. Dr. Glandt gives patients her own food plan, along with free visual guides to low-carbohydrate foods by dietdoctor.com. 

Dr. Glandt also sends her patients for regular blood work. She says she does not frequently see a rise in LDL cholesterol, which can sometimes occur on a low-carbohydrate diet. This effect is most common among people who are lean and fit. She says she doesn’t discontinue statins unless cholesterol levels improve significantly.

Samuel Gonzalez, age 56, weighed 275 pounds when he walked into Dr. Glandt’s office this past November. His A1c was 9.2%, but none of his previous doctors had diagnosed him with diabetes. “I was like a walking bag of sugar!” he joked. 

A low-carbohydrate diet seemed absurd to a Puerto Rican like himself: “Having coffee without sugar? That’s like sacrilegious in my culture!” exclaimed Mr. Gonzalez. Still, he managed, with SNAP, to cook eggs and bacon for breakfast and some kind of protein for dinner. He keeps lunch light, “like tuna fish,” and finds checking in with the OwnaHealth app to be very helpful. “Every day, I’m on it,” he said. In the past 7 months, he’s lost 50 pounds, normalized his cholesterol and blood pressure levels, and lowered his A1c to 5.5%.

Mr. Gonzalez gets disability payments due to a back injury, and Ms. Efem receives government payments because her husband died serving in the military. Ms. Efem says her new diet challenges her budget, but Mr. Gonzalez says he manages easily.

Mélissa Cruz, a 28-year-old studying to be a nail technician while also doing back office work at a physical therapy practice, says she’s stretched thin. “I end up sad because I can’t put energy into looking up recipes and cooking for me and my boyfriend,” she told me. She’ll often cook rice and plantains for him and meat for herself, but “it’s frustrating when I’m low on funds and can’t figure out what to eat.” 

Low-carbohydrate diets have a reputation for being expensive because people often start eating pricier foods, like meat and cheese, to replace cheaper starchy foods such as pasta and rice. Eggs and ground beef are less expensive low-carb meal options, and meat, unlike fruits and vegetables, is easy to freeze and doesn’t spoil quickly. These advantages can add up.

A 2019 cost analysis published in Nutrition & Dietetics compared a low-carbohydrate dietary pattern with the New Zealand government’s recommended guidelines (which are almost identical to those in the United States) and found that it cost only an extra $1.27 in US dollars per person per day. One explanation is that protein and fat are more satiating than carbohydrates, so people who mostly consume these macronutrients often cut back on snacks like packaged chips, crackers, and even fruits. Also, those on a ketogenic diet usually cut down on medications, so the additional $1.27 daily is likely offset by reduced spending at the pharmacy.

It’s not just Bronx residents with low socioeconomic status (SES) who adapt well to low-carbohydrate diets. Among Alabama state employees with diabetes enrolled in a low-carbohydrate dietary program provided by a company called Virta, the low SES population had the best outcomes. Virta also published survey data in 2023 showing that participants in a program with the Veteran’s Administration did not find additional costs to be an obstacle to dietary adherence. In fact, some participants saw cost reductions due to decreased spending on processed snacks and fast foods.

Ms. Cruz told me she struggles financially, yet she’s still lost nearly 30 pounds in 5 months, and her A1c went from 7.1% down to 5.9%, putting her diabetes into remission. Equally motivating for her are the improvements she’s seen in other hormonal issues. Since childhood, she’s had acanthosis, a condition that causes the skin to darken in velvety patches, and more recently, she developed severe hirsutism to the point of growing sideburns. “I had tried going vegan and fasting, but these just weren’t sustainable for me, and I was so overwhelmed with counting calories all the time.” Now, on a low-carbohydrate diet, which doesn’t require calorie counting, she’s finally seeing both these conditions improve significantly.

When I last checked in with Ms. Cruz, she said she had “kind of ghosted” Dr. Glandt due to her work and school constraints, but she hadn’t abandoned the diet. She appreciated, too, that Dr. Glandt had not given up on her and kept calling and messaging. “She’s not at all like a typical doctor who would just tell me to lose weight and shake their head at me,” Ms. Cruz said. 

Because Dr. Glandt’s approach is time-intensive and high-touch, it might seem impractical to scale up, but Dr. Glandt’s app uses artificial intelligence to help with communications thus allowing her, with help from part-time health coaches, to care for patients. 

This early success in one of the United States’ poorest and sickest neighborhoods should give us hope that type 2 diabetes need not to be a progressive irreversible disease, even among the disadvantaged. 

OwnaHealth’s track record, along with that of Virta and other similar low-carbohydrate medical practices also give hope to the food-is-medicine idea. Diabetes can go into remission, and people can be healed, provided that health practitioners prescribe the right foods. And in truth, it’s not a diet. It’s a way of eating that must be maintained. The sustainability of low-carbohydrate diets has been a point of contention, but the Virta trial, with 38% of patients sustaining remission at 2 years, showed that it’s possible. (OwnaHealth, for its part, offers long-term maintenance plans to help patients stay very low-carb permanently.) 

Given the tremendous costs and health burden of diabetes, this approach should no doubt be the first line of treatment for doctors and the ADA. The past two decades of clinical trial research have demonstrated that remission of type 2 diabetes is possible through diet alone. It turns out that for metabolic diseases, only certain foods are truly medicine. 
 

Tools and Tips for Clinicians: 

• Free two-page keto starter’s guide by OwnaHealth; Dr. Glandt uses this guide with her patients.
• Illustrated low-carb guides by dietdoctor.com
• Free low-carbohydrate starter guide by the Michigan Collaborative for Type 2 Diabetes
• Low-Carb for Any Budget, a free digital booklet by Mark Cucuzzella, MD, and Kristie Sullivan, PhD
• Recipe and meal ideas from Ruled.me, Keto-Mojo.com, and 

Dr. Teicholz is the founder of Nutrition Coalition, an independent nonprofit dedicated to ensuring that US dietary guidelines align with current science. She disclosed receiving book royalties from The Big Fat Surprise, and received honorarium not exceeding $2000 for speeches from various sources.

A version of this article appeared on Medscape.com.

For decades it’s been thought that preconception use of the oral antidiabetic metformin by mothers and fathers might result in adverse fetal outcomes, including congenital malformations and stillbirths.

Women with type 2 diabetes (T2D) are often advised to switch to insulin before or during early pregnancy out of concern for fetal safety. But two studies from the Harvard T.H. Chan School of Public Health in Boston, Massachusetts — one in mothers, the other in fathers — report that metformin, a common and cost-effective antidiabetic agent, is not associated with a significant increased risk of teratogenicity and negative perinatal outcomes. The studies appear in Annals of Internal Medicine.

The studies may make it easier for physicians to reassure diabetic parents-to-be about the safety of metformin use before conception and in early pregnancy,

In the context of sparse existing safety data, the maternal analysis looked at Medicaid data on 12,489 mothers (mean age, about 30) receiving metformin for pregestational T2D during the period 2000-2018. “Many women become pregnant while still taking noninsulin oral antidiabetics, mostly metformin, and one safety concern is whether metformin could cause birth defects,” lead author Yu-Han Chiu, MD, ScD, an epidemiologist, said in an interview, commenting on the impetus for the study.

Metformin in Fathers

Turning to fathers, a much larger cohort study by Harvard T.H. Chan investigators looked at the effect of paternal metformin use and also found it to be safe.

The Harvard investigators analyzed diabetic men in 383,851 live births from 1999 to 2020 in an Israeli health fund cohort, excluding those with diabetic spouses. Across different T2D medication groups, paternal age ranged from about 35 to about 43 years. The data revealed that paternal use of metformin monotherapy in the preconception sperm production period was, after adjustment of crude numbers, not associated with major congenital malformations (MCMs) in newborns.

“While metformin has an overall good safety profile, it can lower androgen levels, and there had been some concerns that its use in fathers could alter the sperm, causing adverse effects to the fetus,” lead author and neuroepidemiologist Ran S. Rotem, MD, ScD, of the Harvard School of Public Health, Boston, Massachusetts, said in interview. “Given the increasing prevalence of diabetes in young individuals, more fathers are conceiving a child while using the medication, which could lead to a substantial population effect even if the individual risk is low. But our study suggests that the medication is safe to use by fathers before conception.”

For decades it’s been thought that preconception use of the oral antidiabetic metformin by mothers and fathers might result in adverse fetal outcomes, including congenital malformations and stillbirths.

Women with type 2 diabetes (T2D) are often advised to switch to insulin before or during early pregnancy out of concern for fetal safety. But two studies from the Harvard T.H. Chan School of Public Health in Boston, Massachusetts — one in mothers, the other in fathers — report that metformin, a common and cost-effective antidiabetic agent, is not associated with a significant increased risk of teratogenicity and negative perinatal outcomes. The studies appear in Annals of Internal Medicine.

The studies may make it easier for physicians to reassure diabetic parents-to-be about the safety of metformin use before conception and in early pregnancy,

In the context of sparse existing safety data, the maternal analysis looked at Medicaid data on 12,489 mothers (mean age, about 30) receiving metformin for pregestational T2D during the period 2000-2018. “Many women become pregnant while still taking noninsulin oral antidiabetics, mostly metformin, and one safety concern is whether metformin could cause birth defects,” lead author Yu-Han Chiu, MD, ScD, an epidemiologist, said in an interview, commenting on the impetus for the study.

Metformin in Fathers

Turning to fathers, a much larger cohort study by Harvard T.H. Chan investigators looked at the effect of paternal metformin use and also found it to be safe.

The Harvard investigators analyzed diabetic men in 383,851 live births from 1999 to 2020 in an Israeli health fund cohort, excluding those with diabetic spouses. Across different T2D medication groups, paternal age ranged from about 35 to about 43 years. The data revealed that paternal use of metformin monotherapy in the preconception sperm production period was, after adjustment of crude numbers, not associated with major congenital malformations (MCMs) in newborns.

“While metformin has an overall good safety profile, it can lower androgen levels, and there had been some concerns that its use in fathers could alter the sperm, causing adverse effects to the fetus,” lead author and neuroepidemiologist Ran S. Rotem, MD, ScD, of the Harvard School of Public Health, Boston, Massachusetts, said in interview. “Given the increasing prevalence of diabetes in young individuals, more fathers are conceiving a child while using the medication, which could lead to a substantial population effect even if the individual risk is low. But our study suggests that the medication is safe to use by fathers before conception.”

For decades it’s been thought that preconception use of the oral antidiabetic metformin by mothers and fathers might result in adverse fetal outcomes, including congenital malformations and stillbirths.

Women with type 2 diabetes (T2D) are often advised to switch to insulin before or during early pregnancy out of concern for fetal safety. But two studies from the Harvard T.H. Chan School of Public Health in Boston, Massachusetts — one in mothers, the other in fathers — report that metformin, a common and cost-effective antidiabetic agent, is not associated with a significant increased risk of teratogenicity and negative perinatal outcomes. The studies appear in Annals of Internal Medicine.

The studies may make it easier for physicians to reassure diabetic parents-to-be about the safety of metformin use before conception and in early pregnancy,

In the context of sparse existing safety data, the maternal analysis looked at Medicaid data on 12,489 mothers (mean age, about 30) receiving metformin for pregestational T2D during the period 2000-2018. “Many women become pregnant while still taking noninsulin oral antidiabetics, mostly metformin, and one safety concern is whether metformin could cause birth defects,” lead author Yu-Han Chiu, MD, ScD, an epidemiologist, said in an interview, commenting on the impetus for the study.

Metformin in Fathers

Turning to fathers, a much larger cohort study by Harvard T.H. Chan investigators looked at the effect of paternal metformin use and also found it to be safe.

The Harvard investigators analyzed diabetic men in 383,851 live births from 1999 to 2020 in an Israeli health fund cohort, excluding those with diabetic spouses. Across different T2D medication groups, paternal age ranged from about 35 to about 43 years. The data revealed that paternal use of metformin monotherapy in the preconception sperm production period was, after adjustment of crude numbers, not associated with major congenital malformations (MCMs) in newborns.

“While metformin has an overall good safety profile, it can lower androgen levels, and there had been some concerns that its use in fathers could alter the sperm, causing adverse effects to the fetus,” lead author and neuroepidemiologist Ran S. Rotem, MD, ScD, of the Harvard School of Public Health, Boston, Massachusetts, said in interview. “Given the increasing prevalence of diabetes in young individuals, more fathers are conceiving a child while using the medication, which could lead to a substantial population effect even if the individual risk is low. But our study suggests that the medication is safe to use by fathers before conception.”

An ancient Chinese remedy for malaria could offer new hope to the 10% of reproductive-age women living with polycystic ovarian syndrome (PCOS), a poorly understood endocrine disorder that can cause hormonal imbalances, irregular periods, and cysts in the ovaries.

“PCOS is among the most common disorders of reproductive-age women,” said endocrinologist Andrea Dunaif, MD, a professor at the Icahn School of Medicine at Mount Sinai, New York City, who studies diabetes and women’s health. “It is a major risk factor for obesity, type 2 diabetes, and heart disease.” It’s also a leading cause of infertility.

Yet despite how common it is, PCOS has no Food and Drug Administration–approved treatments, though a few early-stage clinical trials are underway. Many women end up taking off-label medications such as oral contraceptives, insulin-sensitizing agents, and antiandrogens to help manage symptoms. Surgery can also be used to treat fertility problems associated with PCOS, though it may not work for everyone.

In a new study, a derivative of artemisinin — a molecule that comes from Artemisia plants, which have been used as far back as 1596 to treat malaria in China — helped relieve PCOS symptoms in rats and a small group of women.

Previously, the study’s lead researcher Qi-qun Tang, MD, PhD, had found that this derivative, called artemether, can increase thermogenesis, boosting metabolism. Dr. Tang and his team at Fudan University, Shanghai, China, wanted to see if it would help with PCOS, which is associated with metabolic problems such as insulin resistance.
 

What the Researchers Did

To simulate PCOS in rats, the team treated the rodents with insulin and human chorionic gonadotropin. Then, they tested artemether on the rats and found that it lowered androgen production in the ovaries.

“A common feature [of PCOS] is that the ovaries, and often the adrenal glands, make increased male hormones, nowhere near what a man makes but slightly above what a normal woman makes,” said Dr. Dunaif, who was not involved in the study.

Artemether “inhibits one of the steroidogenic enzymes, CYP11A1, which is important in the production of male hormones,” Dr. Tang said. It does this by increasing the enzyme’s interaction with a protein called LONP1, triggering the enzyme’s breakdown. Increased levels of LONP1 also appeared to suppress androgen production in the ovaries.

In a pilot clinical study of 19 women with PCOS, taking dihydroartemisinin — an approved drug used to treat malaria that contains active artemisinin derivatives — for 12 weeks substantially reduced serum testosterone and anti-Müllerian hormone levels (which are higher in women with PCOS). Using ultrasound, the researchers found that the antral follicle count (also higher than normal with PCOS) had been reduced. All participants had regular menstrual cycles during treatment. And no one reported significant side effects.

“Regular menstrual cycles suggest that there is ovulation, which can result in conception,” Dr. Dunaif said. Still, testing would be needed to confirm that cycles are ovulatory.

Lowering androgen levels “could improve a substantial portion of the symptoms of PCOS,” said Dr. Dunaif. But the research didn’t see an improvement in insulin sensitivity among the women, suggesting that targeting androgens may not help the metabolic symptoms.
 

What’s Next? 

A larger, placebo-controlled trial would still be needed to assess the drug’s efficacy, said Dr. Dunaif, pointing out that the human study did not have a placebo arm.

And unanswered questions remain. Are there any adrenal effects of the compound? “The enzymes that produce androgens are shared between the ovary and the adrenal [gland],” Dr. Dunaif said, but she pointed out that the study doesn’t address whether there is an adrenal benefit. It’s something to look at in future research.

Still, because artemisinin is an established drug, it may come to market faster than a new molecule would, she said. However, a pharmaceutical company would need to be willing to take on the drug. (Dr. Tang said several companies have already expressed interest.)

And while you can buy artemisinin on the Internet, Dr. Dunaif warned not to start taking it if you have PCOS. “I don’t think we’re at that point,” Dr. Dunaif said.

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

An ancient Chinese remedy for malaria could offer new hope to the 10% of reproductive-age women living with polycystic ovarian syndrome (PCOS), a poorly understood endocrine disorder that can cause hormonal imbalances, irregular periods, and cysts in the ovaries.

“PCOS is among the most common disorders of reproductive-age women,” said endocrinologist Andrea Dunaif, MD, a professor at the Icahn School of Medicine at Mount Sinai, New York City, who studies diabetes and women’s health. “It is a major risk factor for obesity, type 2 diabetes, and heart disease.” It’s also a leading cause of infertility.

Yet despite how common it is, PCOS has no Food and Drug Administration–approved treatments, though a few early-stage clinical trials are underway. Many women end up taking off-label medications such as oral contraceptives, insulin-sensitizing agents, and antiandrogens to help manage symptoms. Surgery can also be used to treat fertility problems associated with PCOS, though it may not work for everyone.

In a new study, a derivative of artemisinin — a molecule that comes from Artemisia plants, which have been used as far back as 1596 to treat malaria in China — helped relieve PCOS symptoms in rats and a small group of women.

Previously, the study’s lead researcher Qi-qun Tang, MD, PhD, had found that this derivative, called artemether, can increase thermogenesis, boosting metabolism. Dr. Tang and his team at Fudan University, Shanghai, China, wanted to see if it would help with PCOS, which is associated with metabolic problems such as insulin resistance.
 

What the Researchers Did

To simulate PCOS in rats, the team treated the rodents with insulin and human chorionic gonadotropin. Then, they tested artemether on the rats and found that it lowered androgen production in the ovaries.

“A common feature [of PCOS] is that the ovaries, and often the adrenal glands, make increased male hormones, nowhere near what a man makes but slightly above what a normal woman makes,” said Dr. Dunaif, who was not involved in the study.

Artemether “inhibits one of the steroidogenic enzymes, CYP11A1, which is important in the production of male hormones,” Dr. Tang said. It does this by increasing the enzyme’s interaction with a protein called LONP1, triggering the enzyme’s breakdown. Increased levels of LONP1 also appeared to suppress androgen production in the ovaries.

In a pilot clinical study of 19 women with PCOS, taking dihydroartemisinin — an approved drug used to treat malaria that contains active artemisinin derivatives — for 12 weeks substantially reduced serum testosterone and anti-Müllerian hormone levels (which are higher in women with PCOS). Using ultrasound, the researchers found that the antral follicle count (also higher than normal with PCOS) had been reduced. All participants had regular menstrual cycles during treatment. And no one reported significant side effects.

“Regular menstrual cycles suggest that there is ovulation, which can result in conception,” Dr. Dunaif said. Still, testing would be needed to confirm that cycles are ovulatory.

Lowering androgen levels “could improve a substantial portion of the symptoms of PCOS,” said Dr. Dunaif. But the research didn’t see an improvement in insulin sensitivity among the women, suggesting that targeting androgens may not help the metabolic symptoms.
 

What’s Next? 

A larger, placebo-controlled trial would still be needed to assess the drug’s efficacy, said Dr. Dunaif, pointing out that the human study did not have a placebo arm.

And unanswered questions remain. Are there any adrenal effects of the compound? “The enzymes that produce androgens are shared between the ovary and the adrenal [gland],” Dr. Dunaif said, but she pointed out that the study doesn’t address whether there is an adrenal benefit. It’s something to look at in future research.

Still, because artemisinin is an established drug, it may come to market faster than a new molecule would, she said. However, a pharmaceutical company would need to be willing to take on the drug. (Dr. Tang said several companies have already expressed interest.)

And while you can buy artemisinin on the Internet, Dr. Dunaif warned not to start taking it if you have PCOS. “I don’t think we’re at that point,” Dr. Dunaif said.

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

An ancient Chinese remedy for malaria could offer new hope to the 10% of reproductive-age women living with polycystic ovarian syndrome (PCOS), a poorly understood endocrine disorder that can cause hormonal imbalances, irregular periods, and cysts in the ovaries.

“PCOS is among the most common disorders of reproductive-age women,” said endocrinologist Andrea Dunaif, MD, a professor at the Icahn School of Medicine at Mount Sinai, New York City, who studies diabetes and women’s health. “It is a major risk factor for obesity, type 2 diabetes, and heart disease.” It’s also a leading cause of infertility.

Yet despite how common it is, PCOS has no Food and Drug Administration–approved treatments, though a few early-stage clinical trials are underway. Many women end up taking off-label medications such as oral contraceptives, insulin-sensitizing agents, and antiandrogens to help manage symptoms. Surgery can also be used to treat fertility problems associated with PCOS, though it may not work for everyone.

In a new study, a derivative of artemisinin — a molecule that comes from Artemisia plants, which have been used as far back as 1596 to treat malaria in China — helped relieve PCOS symptoms in rats and a small group of women.

Previously, the study’s lead researcher Qi-qun Tang, MD, PhD, had found that this derivative, called artemether, can increase thermogenesis, boosting metabolism. Dr. Tang and his team at Fudan University, Shanghai, China, wanted to see if it would help with PCOS, which is associated with metabolic problems such as insulin resistance.
 

What the Researchers Did

To simulate PCOS in rats, the team treated the rodents with insulin and human chorionic gonadotropin. Then, they tested artemether on the rats and found that it lowered androgen production in the ovaries.

“A common feature [of PCOS] is that the ovaries, and often the adrenal glands, make increased male hormones, nowhere near what a man makes but slightly above what a normal woman makes,” said Dr. Dunaif, who was not involved in the study.

Artemether “inhibits one of the steroidogenic enzymes, CYP11A1, which is important in the production of male hormones,” Dr. Tang said. It does this by increasing the enzyme’s interaction with a protein called LONP1, triggering the enzyme’s breakdown. Increased levels of LONP1 also appeared to suppress androgen production in the ovaries.

In a pilot clinical study of 19 women with PCOS, taking dihydroartemisinin — an approved drug used to treat malaria that contains active artemisinin derivatives — for 12 weeks substantially reduced serum testosterone and anti-Müllerian hormone levels (which are higher in women with PCOS). Using ultrasound, the researchers found that the antral follicle count (also higher than normal with PCOS) had been reduced. All participants had regular menstrual cycles during treatment. And no one reported significant side effects.

“Regular menstrual cycles suggest that there is ovulation, which can result in conception,” Dr. Dunaif said. Still, testing would be needed to confirm that cycles are ovulatory.

Lowering androgen levels “could improve a substantial portion of the symptoms of PCOS,” said Dr. Dunaif. But the research didn’t see an improvement in insulin sensitivity among the women, suggesting that targeting androgens may not help the metabolic symptoms.
 

What’s Next? 

A larger, placebo-controlled trial would still be needed to assess the drug’s efficacy, said Dr. Dunaif, pointing out that the human study did not have a placebo arm.

And unanswered questions remain. Are there any adrenal effects of the compound? “The enzymes that produce androgens are shared between the ovary and the adrenal [gland],” Dr. Dunaif said, but she pointed out that the study doesn’t address whether there is an adrenal benefit. It’s something to look at in future research.

Still, because artemisinin is an established drug, it may come to market faster than a new molecule would, she said. However, a pharmaceutical company would need to be willing to take on the drug. (Dr. Tang said several companies have already expressed interest.)

And while you can buy artemisinin on the Internet, Dr. Dunaif warned not to start taking it if you have PCOS. “I don’t think we’re at that point,” Dr. Dunaif said.

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

BOSTON — An investigational male contraceptive gel suppresses sperm more rapidly than previous products in development, new data suggested.

The product, 8 mg segesterone acetate (Nestorone) combined with 74 mg testosterone (“NesT”) is a gel that a man applies daily to both shoulders. The progesterone blocks spermatogenesis, and the testosterone restores blood levels to maintain sexual function. It is under development by the National Institute of Child Health and Human Development (NICHD) in collaboration with the Population Council, the Los Angeles Biomedical Research Institute, and the University of Washington School of Medicine.

Currently, the only available male contraceptives are vasectomy, which isn’t easily reversible, and condoms, which have a high failure rate. Previous attempts to develop a “male pill” have been unsuccessful for a variety of reasons, but so far, this product appears effective and safe, Diana Blithe, PhD, chief of the Contraceptive Development Program at NICHD, said at a press briefing held on June 2, 2024, during the annual meeting of the Endocrine Society.

“It’s been a long time coming. … Men need and want more contraceptive options such as an effective reversible method,” she told this news organization.

New phase 2b data show that among 222 couples in which the man initially had normal (> 15 million/mL) sperm counts, the median time to suppression (< 1 million/mL) was less than 8 weeks with NesT compared with 9-15 weeks seen in previous trials of injected male hormonal contraceptives. Nearly all (86%) had achieved suppression by 15 weeks.

After two consecutive counts of < 1 million/mL, the couples entered the trial’s ongoing 2-year efficacy phase. There have been no major safety concerns thus far, but “we need more data,” Dr. Blithe noted.

Asked to comment, session moderator Frances Hayes, MBBCh, associate clinical chief of the Division of Reproductive Endocrinology at Massachusetts General Hospital, Boston, said, “certainly, I think it’s a big advance on what we have so far. … I think it’s showing great promise.”

Dr. Hayes did caution, though, that “with real-world use, daily application of a gel might be a bit more challenging than taking an injection…an injection is more consistent. With a gel, patients might forget or shower it off. But I don’t think 1 day of interruption would be a significant thing.”

Transference of the topical to a partner or a child is another potential concern, Dr. Hayes noted, although this is true of current testosterone gel products as well. During the briefing, Dr. Blithe said that this issue is why the product is recommended to be placed on the upper arms rather than the abdomen or another spot more likely to come into contact with another person. Also, in the trial, men were instructed to wear shirts during intercourse.

Regarding the rapidity of sperm suppression, Dr. Hayes said, “It’s surprising. It looks great as a reversible contraceptive. … Normally, you think of the life cycle of the sperm being about 72 days. So to see 50% suppression by 8 weeks, and then 85%-90% by 15 weeks, that’s very rapid. It may be that the progesterone that they’re using is very potent. Progestins can have some negative effects on lipids and mood. We didn’t really see the safety data in this presentation. So that will be interesting to see.”

During the briefing, Dr. Blithe said that the phase 2b trial is expected to finish by the end of this year, and in the meantime, the researchers are communicating with the US Food and Drug Administration about the design of a phase 3 trial because this is an unprecedented area. “They don’t have guidelines yet. They’ll need to develop them first.”

Dr. Blithe has been the NICHD principal investigator on cooperative research and development agreements with HRA Pharma and Daré Bioscience. Dr. Hayes had no disclosures.

A version of this article appeared on Medscape.com .

BOSTON — An investigational male contraceptive gel suppresses sperm more rapidly than previous products in development, new data suggested.

The product, 8 mg segesterone acetate (Nestorone) combined with 74 mg testosterone (“NesT”) is a gel that a man applies daily to both shoulders. The progesterone blocks spermatogenesis, and the testosterone restores blood levels to maintain sexual function. It is under development by the National Institute of Child Health and Human Development (NICHD) in collaboration with the Population Council, the Los Angeles Biomedical Research Institute, and the University of Washington School of Medicine.

Currently, the only available male contraceptives are vasectomy, which isn’t easily reversible, and condoms, which have a high failure rate. Previous attempts to develop a “male pill” have been unsuccessful for a variety of reasons, but so far, this product appears effective and safe, Diana Blithe, PhD, chief of the Contraceptive Development Program at NICHD, said at a press briefing held on June 2, 2024, during the annual meeting of the Endocrine Society.

“It’s been a long time coming. … Men need and want more contraceptive options such as an effective reversible method,” she told this news organization.

New phase 2b data show that among 222 couples in which the man initially had normal (> 15 million/mL) sperm counts, the median time to suppression (< 1 million/mL) was less than 8 weeks with NesT compared with 9-15 weeks seen in previous trials of injected male hormonal contraceptives. Nearly all (86%) had achieved suppression by 15 weeks.

After two consecutive counts of < 1 million/mL, the couples entered the trial’s ongoing 2-year efficacy phase. There have been no major safety concerns thus far, but “we need more data,” Dr. Blithe noted.

Asked to comment, session moderator Frances Hayes, MBBCh, associate clinical chief of the Division of Reproductive Endocrinology at Massachusetts General Hospital, Boston, said, “certainly, I think it’s a big advance on what we have so far. … I think it’s showing great promise.”

Dr. Hayes did caution, though, that “with real-world use, daily application of a gel might be a bit more challenging than taking an injection…an injection is more consistent. With a gel, patients might forget or shower it off. But I don’t think 1 day of interruption would be a significant thing.”

Transference of the topical to a partner or a child is another potential concern, Dr. Hayes noted, although this is true of current testosterone gel products as well. During the briefing, Dr. Blithe said that this issue is why the product is recommended to be placed on the upper arms rather than the abdomen or another spot more likely to come into contact with another person. Also, in the trial, men were instructed to wear shirts during intercourse.

Regarding the rapidity of sperm suppression, Dr. Hayes said, “It’s surprising. It looks great as a reversible contraceptive. … Normally, you think of the life cycle of the sperm being about 72 days. So to see 50% suppression by 8 weeks, and then 85%-90% by 15 weeks, that’s very rapid. It may be that the progesterone that they’re using is very potent. Progestins can have some negative effects on lipids and mood. We didn’t really see the safety data in this presentation. So that will be interesting to see.”

During the briefing, Dr. Blithe said that the phase 2b trial is expected to finish by the end of this year, and in the meantime, the researchers are communicating with the US Food and Drug Administration about the design of a phase 3 trial because this is an unprecedented area. “They don’t have guidelines yet. They’ll need to develop them first.”

Dr. Blithe has been the NICHD principal investigator on cooperative research and development agreements with HRA Pharma and Daré Bioscience. Dr. Hayes had no disclosures.

A version of this article appeared on Medscape.com .

BOSTON — An investigational male contraceptive gel suppresses sperm more rapidly than previous products in development, new data suggested.

The product, 8 mg segesterone acetate (Nestorone) combined with 74 mg testosterone (“NesT”) is a gel that a man applies daily to both shoulders. The progesterone blocks spermatogenesis, and the testosterone restores blood levels to maintain sexual function. It is under development by the National Institute of Child Health and Human Development (NICHD) in collaboration with the Population Council, the Los Angeles Biomedical Research Institute, and the University of Washington School of Medicine.

Currently, the only available male contraceptives are vasectomy, which isn’t easily reversible, and condoms, which have a high failure rate. Previous attempts to develop a “male pill” have been unsuccessful for a variety of reasons, but so far, this product appears effective and safe, Diana Blithe, PhD, chief of the Contraceptive Development Program at NICHD, said at a press briefing held on June 2, 2024, during the annual meeting of the Endocrine Society.

“It’s been a long time coming. … Men need and want more contraceptive options such as an effective reversible method,” she told this news organization.

New phase 2b data show that among 222 couples in which the man initially had normal (> 15 million/mL) sperm counts, the median time to suppression (< 1 million/mL) was less than 8 weeks with NesT compared with 9-15 weeks seen in previous trials of injected male hormonal contraceptives. Nearly all (86%) had achieved suppression by 15 weeks.

After two consecutive counts of < 1 million/mL, the couples entered the trial’s ongoing 2-year efficacy phase. There have been no major safety concerns thus far, but “we need more data,” Dr. Blithe noted.

Asked to comment, session moderator Frances Hayes, MBBCh, associate clinical chief of the Division of Reproductive Endocrinology at Massachusetts General Hospital, Boston, said, “certainly, I think it’s a big advance on what we have so far. … I think it’s showing great promise.”

Dr. Hayes did caution, though, that “with real-world use, daily application of a gel might be a bit more challenging than taking an injection…an injection is more consistent. With a gel, patients might forget or shower it off. But I don’t think 1 day of interruption would be a significant thing.”

Transference of the topical to a partner or a child is another potential concern, Dr. Hayes noted, although this is true of current testosterone gel products as well. During the briefing, Dr. Blithe said that this issue is why the product is recommended to be placed on the upper arms rather than the abdomen or another spot more likely to come into contact with another person. Also, in the trial, men were instructed to wear shirts during intercourse.

Regarding the rapidity of sperm suppression, Dr. Hayes said, “It’s surprising. It looks great as a reversible contraceptive. … Normally, you think of the life cycle of the sperm being about 72 days. So to see 50% suppression by 8 weeks, and then 85%-90% by 15 weeks, that’s very rapid. It may be that the progesterone that they’re using is very potent. Progestins can have some negative effects on lipids and mood. We didn’t really see the safety data in this presentation. So that will be interesting to see.”

During the briefing, Dr. Blithe said that the phase 2b trial is expected to finish by the end of this year, and in the meantime, the researchers are communicating with the US Food and Drug Administration about the design of a phase 3 trial because this is an unprecedented area. “They don’t have guidelines yet. They’ll need to develop them first.”

Dr. Blithe has been the NICHD principal investigator on cooperative research and development agreements with HRA Pharma and Daré Bioscience. Dr. Hayes had no disclosures.

A version of this article appeared on Medscape.com .