European Association for the Study of Diabetes 2020 Annual Meeting

EASD 2020

Women with type 1 diabetes had a shorter reproductive life span than their counterparts without 

, according to the results of a new study.

An analysis of data from the Pittsburgh Epidemiology of Diabetes Complications (EDC) and Study of Women’s Health Across the Nation (SWAN) studies, results indicate women with type 1 diabetes before menarche had a shorter reproductive period than women without diabetes.

"This study found that women with the onset of type 1 diabetes before menarche were at increased risk for a shorter reproductive lifespan. Thus, these women are not only at risk for premature ovarian aging because of early onset type 1 diabetes, they are also at increased risk for cardiovascular disease, osteoporosis, and early mortality because of early natural menopause. Understanding these risks and targeting appropriate risk-reducing strategies are key to optimizing the health and quality of life of these women,” said Stephanie Faubion, MD, medical director of the North American Menopause Society, 

While the role of insulin in regulating female reproductive function has been well-documented, investigators identified what they saw as a gap in knowledge related to the onset of type 1 diabetes and the age of natural menopause. With this in mind, a team of 8 investigators from the University of Pittsburgh birthed the current study with the aim of filling that knowledge gap.

To do so, investigators designed the current study to use data from the Pittsburgh EDC study for women with type 1 diabetes and the SWAN study for women without diabetes. From the Pittsburgh EDC study, investigators identified 105 women diagnosed with childhood-onset type 1 diabetes between 1950-1980. From the SWAN study, investigators identified a reference cohort of 175 women with no diabetes.

Of note, women were excluded if they did not reach natural menopause, if they underwent a hysterectomy or oophorectomy before menopause, or received sex hormone therapy during the menopausal transition. For the purpose of analysis, historical and Women’s Ischemic Syndrome Evaluation hormonal algorithms were used to assess menopause status of participants. For both studies, length of reproductive lifespan was calculated by subtracting the age at menarche from the age at natural menopause.

Compared to those without diabetes, women in the type 1 diabetes cohort were younger, more likely to be white, more likely to be never smokers, have a lower BMI, and higher levels of HDL-C (

 <.05). In adjusted analyses, women with type 1 diabetes were older at menarche our younger at natural menopause. Further analysis suggested women with type 1 diabetes experienced 2.5 fewer reproductive years than their counterparts without diabetes. Investigators pointed out findings from these analyses were restricted to a subgroup of 80 women who were diagnosed with type 1 diabetes before reaching menarche.

“The present study identified the subgroup of women with type 1 diabetes who have a high likelihood of experiencing early age at natural menopause so that efforts to unearth the biologic rationale and target potential prevention practices would be better focused,” wrote investigators.

Women with Type 1 diabetes (T1D) experience a shorter reproductive period compared with nondiabetic women: the Pittsburgh Epidemiology of Diabetes Complications (EDC) study and the Study of Women’s Health Across the Nation (SWAN),”

Journal of the North American Menopause Society.

Articles

An analysis of data from 2 major studies suggests women with childhood-onset type 1 diabetes experienced 2.5 fewer reproductive years than their counterparts without diabetes. 

Type 1 Diabetes Shortens Reproductive Lifespan in Women

Could the presence of kidney stones help clinicians identify patients at risk for osteoporosis? A new study from Stanford University has uncovered a possible link between kidney stone disease and risk of 

An analysis of more than half a million patients with kidney stones disease, results indicate nearly 1-in-4 patients received a diagnosis of osteoporosis or suffered a bone fracture and suggest screening of these patients for increased risk remains subpar.

"We hope this work raises awareness regarding the possibility of reduced bone strength in patients with kidney stones. In our future work, we hope to identify which patients with kidney stones are at higher risk for osteoporosis or fracture to help guide bone density screening efforts by clinicians in this population," said lead investigator Calyani Ganesan, MD, a nephrology fellow at Stanford University, 

With osteoporosis and fractures posing a serious threat to the well-being and quality of life of aging adults, Ganesan and colleagues from Stanford University sought to determine whether kidney stone disease was associated with increased risk of osteoporosis. Investigators designed their analysis as a retrospective cohort study using data from the Veterans Health Administration database.

Patients were considered to have kidney stone disease if they had at least one inpatient encounter that included ICD-9 and ICD-10 codes for kidney or ureteral stones. In total, investigates identified 531,431 patients with kidney stone disease treated. Between January 1, 2007-December 31, 2015. Of these, 125,427 had a diagnosis of osteoporosis or fracture in the 5 years preceding or 5 years following index stone diagnosis. Of the 125,527, 32,613 (6.1%) were diagnosed with osteoporosis.

In adjusted models, results suggested presence of type 2 diabetes (OR, 1.07; 95% CI, 1.05-1.09), metastatic cancer (OR, 1.15; 95% CI, 1.11-1.20), enteric disease (OR, 1.19; 95% CI, 1.08-1.31), hypogonadism (OR, 1.22; 95% CI, 1.14-1.29), and primary hyperparathyroidism (OR, 1.59; 95% CI, 1.43-1.76) were associated with increased risk of receiving a diagnosis of fracture or osteoporosis after index stone diagnosis.

When assessing rates of dual-energy X-ray absorptiometry (DXA) among those with no history of osteoporosis or fracture before a kidney stone diagnosis, investigators found just 9.1% (n=42,329) of patients meeting these criteria underwent DXA in the 5 years following their initial diagnosis. Of those who did undergo DXA, 20% were subsequently diagnosed with osteoporosis, 19% (n=8055) were diagnosed with a non-hip fracture, and 2.4% (n=1008) were diagnosed with a hip fracture. Investigators pointed out 85% of patients who were screened and later diagnosed with osteoporosis were men.

Further analysis indicated odds of being screened with DXA were greater among patients with a history of hypogonadism (OR = 2.07; 95% CI 1.95–2.20) or primary hyperparathyroidism (OR = 4.99; 95% CI 4.57–5.44). Additionally, results suggested patients had decreased odds of undergoing DXA if they had a history of metastatic cancer (OR, 0.93; 95% CI, 0.88-0.98).

“Our findings provide support for wider use of bone mineral density screening in patients with kidney stone disease, including middle-aged and older men, for whom efforts to mitigate risks of osteoporosis and fractures are not commonly emphasized,” wrote investigators.

Osteoporosis, Fractures, and Bone Mineral Density Screening in Veterans With Kidney Stone Disease,

An analysis of data from the Veterans Health Administration is providing insight into the apparent increase in risk of fracture or osteoporosis among older adults with kidney or ureteral stones.

Study Links Kidney Stones to Fracture Risk in Older Adults

 firmly rooted in the US and rapidly expanding its grip throughout the rest of the world, avenues for mitigating the risk of obesity itself and its complications are crucial to the wellbeing of patients and the population as a whole.

Currently, most avenues for weight loss include intensive lifestyle interventions, increased physical activity, possible medication regimens, and bariatric surgery—the most aggressive treatment option. However, 2 new trials from Novo Nordisk’s STEP program suggest an alternate dosage of subcutaneous semaglutide could be the answer to addressing the issue.

Already approved in 0.5 and 1.0 mg dosage as an adjunct therapy for patients with 

, the STEP program is aimed at assessing subcutaneous semaglutide for the treatment of obesity. In total, the program includes 5 trials examining a 2.4 mg dosage of the GLP1-RA.

At the beginning of March 2021, the results of STEP 1 and STEP 3 had been published in full in the 

respectively. Both trials demonstrated the beneficial effects of subcutaneous semaglutide in overweight or obese patients, with the major difference between the trials being the intensive behavioral treatment undergone by those in STEP 3.

For further insight into the effects of subcutaneous semaglutide and key differences between the trials included in the STEP program, 

 reached out to Thomas Wadden, PhD, a clinical psychologist and principal investigator of STEP 1 and STEP 3.

Videos

Published in late February, results of the STEP 1 and STEP 3 trial give clinicians insight into the effects of 2.4 mg subcutaneous semaglutide as an intervention for weight loss in overweight or obese patients ahead of a potential approval in June 2021. 

STEP 1 and STEP 3 Results with Thomas Wadden, PhD

A source of controversy in many disease states, new research suggests vitamin D levels do not impact the risk of type 1 diabetes in patients.

Despite previous studies suggesting vitamin D deficiency was linked to type 1 diabetes, results of the current study, which included nearly half a million patients, indicate genetically-determined vitamin D levels were unlikely to have a large effect on risk of type 1 diabetes.

"Our findings do not support a large effect of vitamin D levels on type 1 diabetes, but there may be smaller effects which we could not detect. Until further evidence from large RCTs, we cannot suggest the use of vitamin D supplements as a strategy to prevent type 1 diabetes in individuals at risk, for instance siblings or offspring of people with type 1 diabetes,” said Despoina Manousaki, MD, PhD, a pediatric endocrinologist and assistant professor the University of Montreal, 

In recent memory, few topics have received as much attention as the role of vitamin D levels in multiple diseases. With some observational studies suggesting low vitamin D levels were linked to risk of type 1 diabetes, investigators hoped to evaluate this association in a two-sample Mendelian randomization model.

For the purpose of analysis, investigators used single nucleotide polymorphisms (SNPs) that are strongly associated with 25-hydroxyvitamin D (25OHD) levels from a large genome-wide association study (GWAS) of 443,734 patients in Europe. Investigators used data from 12 different type 1 diabetes GWAS studies to obtain information related to 9358 cases of type 1 diabetes and 15,705 controls.

In their main analyses, investigators used inverse variance weighted Mendelian randomization and applied 3 additional methods to control for pleiotropy and compared the respective Mendelian randomization estimates. Additionally, investigators used sensitivity analyses excluding SNPs with potential pleiotropic effects. In total, investigators identified 69 lead independent common SNPs to be genome-wide significant for 25OHD, which explains 3.1% of the variance in 25OHD levels.

Upon analysis, results suggested that a 1 SD decrease in standardized natural log-transformed 25OHD was not associated with an increase in type 1 diabetes risk (IVW OR, 1.09; 95% CI, 0.86-1.40; 

 =.48). Investigators also observed similar results using 3 pleiotropy robust Mendelian randomization methods and in sensitivity analyses excluding SNPs associated with serum lipid levels, body composition, blood traits, and type 2 diabetes.

“Our results identified no large impact of a genetically determined reduction in 25OHD levels on type 1 diabetes risk. This provides critical insight into a complex disease that remains poorly understood. Our findings imply that the observational associations between 25OHD and risk of type 1 diabetes might be due to environmental confounders, such as latitude, which is correlated with exposure to sun and skin pigmentation, but this needs to be investigated in further studies,” wrote investigators.

Vitamin D levels and risk of type 1 diabetes: A Mendelian randomization study

Results of a two-sample Mendelian randomization analysis suggest vitamin D levels were unlikely to have a large effect on a person's risk for developing type 1 diabetes. 

Vitamin D Deficiency Not Linked to Type 1 Diabetes, Study Finds

This article was originally published on 

A recent study from Tufts University suggests nearly 2-in-3 COVID-19 hospitalizations were attributable to the presence of 4 specific cardiometabolic conditions.

An analysis that included data from more than 900,000 COVID-19 hospitalizations, results indicate 64% of hospitalizations were attributable to obesity, hypertension, diabetes, and heart failure—with more than 30% of all hospitalizations attributable to obesity alone.

"While newly authorized COVID-19 vaccines will eventually reduce infections, we have a long way to go to get to that point. Our findings call for interventions to determine whether improving cardiometabolic health will reduce hospitalizations, morbidity, and health care strains from COVID-19," said Dariush Mozaffarian, MD, DrPH, lead investigator and dean of the Gerald J. and Dorothy R. Friedman School of Nutrition Science and Policy at Tufts University, 

. "We know that changes in diet quality alone, even without weight loss, rapidly improve metabolic health within just six to eight weeks. It's crucial to test such lifestyle approaches for reducing severe COVID-19 infections, both for this pandemic and future pandemics likely to come."

With previous observational studies linking the aforementioned cardiometabolic conditions to increased risk of severe outcomes with COVID-19, Mozaffarian and colleagues from the Friedman School sought to assess absolute and proportional COVID-19 hospitalizations attributable to each condition, jointly and separately, and according to race/ethnicity, age, and sex. Designed as a comparative risk assessment, investigators chose the NHANES 2015-2018 for cardiometabolic conditions and Centers for Disease Control and Prevention’s Coronavirus Disease 2019–Associated Hospitalization Surveillance Network (COVID-NET) database and from the COVID Tracking Project for COVID-19 hospitalizations as data sources for their study.

Investigators identified a total of 906,849 hospitalizations for COVID-19 among US adults that had occurred as of November 18, 2020. When assessing the proportion of hospitalizations attributable to each disease separately, results of the model indicated 274,322 (30.2%) were attributable to obesity, 237,738 (26.2%) were attributable to hypertension, 185,678 (20.5%) were attributable to diabetes, and 106,139 (11.7.%) were attributable to heart failure. When assessing the conditions jointly, results indicated the four conditions accounted for 575,419 (63.5%) of the 906,849 hospitalizations. Investigators pointed out further analysis suggested 10% reductions in national prevalence rates of each condition could have prevented approximately 11% of COVID-19 hospitalizations.

Like many previous studies, the investigators’ analysis also revealed disparities in COVID-19 attributable to these conditions based age and race/ethnicity. Specific disparities highlighted within the study included age-based disparities in hospitalizations attributable to diabetes and increased attributability to all four conditions among Black adults than White adults. Investigators also noted some disparities appeared to become greater when combing age and race/ethnicity into comparative models.

"Medical providers should educate patients who may be at risk for severe COVID-19 and consider promoting preventive lifestyle measures, such as improved dietary quality and physical activity, to improve overall cardiometabolic health. It's also important for providers to be aware of the health disparities people with these conditions often face," said first investigator Meghan O'Hearn, a doctoral candidate at the Friedman School, in the aforementioned statement.

Investigators cautioned clinicians to consider limitations within their study before overinterpreting the results. These limitations included inability to prove causation and the inability to prove improvements will reduce risk of COVID-19 hospitalization.

Coronavirus Disease 2019 Hospitalizations Attributable to Cardiometabolic Conditions in the United States: A Comparative Risk Assessment Analysis

Journal of the American Heart Association.

An AHA study suggests nearly 66% of all COVID-19 hospitalizations could be attributed to the presence of obesity, diabetes, hypertension, or heart failure. 

Diabetes, 3 Other Metabolic Conditions Responsible for 2-in-3 COVID-19 Hospitalizations

While studies have exhaustively examined links between physical activity levels and risk of death or cardiovascular disease, a new study from Lund University in Sweden is providing insight into the beneficial effects of physical activity on fracture risk in aging adults.

The study, which examined the impact of multiple variables on fracture risk in more than 30,000 middle-aged patients, returned results suggesting even moderate levels of leisure-time physical activity reduced fracture risk compared to those with low levels of activity.

“Our results support the theory that even moderate physical activity in adulthood is beneficial for preventing future fractures. Furthermore, these results indicate the importance of social and psychological factors for the risk of future fractures, with subjects living alone having a 10% increased risk after adjustment for potential confounders,” wrote investigators.

As it stands, further clarification and identification of risk factors for conditions like osteoporosis could result in tangible benefits for patients in the way of reduced fracture risk. With this in mind, a trio of investigators sought to determine what aspects of physical activity and psychosocial situation were associated with incident fracture.

For the purpose of their analysis, investigators chose to pull patient data from the Malmö Diet and Cancer (MDC) study, which was a prospective population-based cohort study that enrolled 30,477 patients from 1991-1996 and followed them through 2016. Of these, 18,325 patients were female. The overall study cohort had a mean age of 58.0±7.6, the median follow-up time was 20.7 (IQR, 9.5) years, and an incident fracture occurred in 8240 (27%) of participants.

Investigators chose first incident fracture of the spine, thoracic cage, arms, shoulders, hands, pelvis, hips, or legs as the primary outcome of their study. These incident fracture events were identified through the National Patient Register. Associations between baseline variables and incident fracture were assessed in Cox regression models. Of note, baseline variables included in the investigators’ analysis included age, sex, BMI, systolic blood pressure, diastolic blood pressure, current smoking status, and daily alcohol intake.

In their analyses, results indicated age, female sex, body mass index, previous fracture, reported family history of fracture (

for all <.001), low leisure-time physical activity (

 <.001), and no or high alcohol consumption (

=.005) were factors independently associated with incident fracture. Additionally, results also indicated fracture risk score was strongly associated with incident fracture (

When assessing fracture risk in men, the incidence rate was 23.2 per 1000 person-years among men with 6 or more risk factors compared to 5.3 per 1000 person-years in those with no risk factors (HR, 5.5; 95% CI, 3.7-8.2). Among women, the incidence rate was 10.7 per 1000 person-years in those with no risk factors and 28.4 per 1000 person-years in women with 6 or more risk factors (HR, 3.1; 95% CI, 2.4-4.0).

For physical activity, results suggested even moderate levels of lesser-time physical activity were associated with a lower risk of incident fracture. Investigators pointed out results also suggested heavy work, living alone, smoking, and no or high alcohol consumption was associated with increased risk of incident fracture.

“In particular, a combination of several risk factors distinctly increases the fracture risk in later life. Our results emphasize the importance of these factors in public health initiatives for prevention of fractures,” wrote investigators.

Physical Activity and Psychosocial Factors Associated With Risk of Future Fractures in Middle-Aged Men and Women,

An analysis of more than 30k middle-aged adults from a prospective cohort study in Sweden is providing insight into the effects of exercise and other variables on fracture risk in these patients. 

Moderate Physical Activity Could Lower Fracture Risk in Middle-Aged Adults

New research from an international team based in London indicates measurements of sodium levels in the blood of patients hospitalized with COVID-19 could help clinicians identify patients at a greater risk of death or respiratory failure.

The analysis, which included data from nearly 500 patients hospitalized with COVID-19 at a pair of London-based hospitals, indicates patients who developed high sodium levels during their hospital stay were 3 times more likely to die than those who maintained normal sodium levels.

"This study shows for the first time that patients presenting at the hospital with COVID-19 and low sodium are twice as likely to need intubation or other means of advanced breathing support as those with normal sodium," said lead investigator Ploutarchos Tzoulis, MD, PhD, MSc, Honorary Associate Professor in Endocrinology at University College London (UCL) Medical School in London, 

In the past, research has established a link between dysnatremia and risk of mortality among patients with bacterial pneumonia. With this in mind, investigators sought to determine whether measurements of sodium concentration in patients with COVID-19 provided any prognostic value. To do so, they designed their analysis as a retrospective longitudinal cohort study of patients presenting with COVID-19 to a pair of hospitals in London from February-May 2020.

All patients identified for inclusion in the analysis were aged 16 years or older and had a positive RT-PCRT test for SARS-CoV-2 on nasopharyngeal swab or other specimen. During their hospitalization, participants underwent measurements of serum sodium, urea, creatinine, and CRP on the day of presentation, day 3, day 6, day 11, day 18, the day of admission to the ICU, and within the 48 hours prior to discharge or death.

Primary outcome measurements for the study included inpatient mortality, need for advanced respiratory support, and acute kidney injury. For the purpose of analysis, hyponatremia was defined as a serum sodium level less than 135 mmol/L and hypernatremia as a serum sodium level greater than 145 mmol/L.

In total, 488 patients were identified for inclusion in the study. This cohort had a median age of 68 years. At presentation, 24.6% of patients were hyponatremic and 5.3% had hypernatremia. Investigators noted most cases of hyponatremia were due to hypovolemia.

In their analyses, hypernatremia two days after admission and exposure to hypernatremia at any point during hospitalization was associated with a 2.34-fold (95% CI, 1.08-5.05; 

=.0014) and a 3.05-fold (95% CI, 1.69-5.49; 

<.0001), respectively, increased risk of death compared to their normonatremic counterparts. Further analysis suggested hyponatremia at admission was associated with a 2.18-fold (95% CI, 1.34-3.45; 

=.0011) increase in risk of needing ventilatory support.

Investigators also pointed out hyponatremia was not a risk factor for in-hospital mortality, except among a subgroup of patients with hypovolemic hyponatremia. Additionally, sodium levels were not associated with risk for acute kidney injury or length of hospitalization.

"Sodium measurements can inform doctors about which COVID-19 patients are at high risk of deterioration and death," Tzoulis added. "Sodium levels can guide decision making about whether a COVID-19 patient needs hospital admission or monitoring in the intensive care unit."

Dysnatremia is a predictor for morbidity and mortality in hospitalized patients with COVID-19,

Journal of Clinical Endocrinology & Metabolism.

An analysis of nearly 500 patients hospitalized with COVID-19 from London suggests dysnatremia could help signal which patients were at an increased risk of complications, including death and need for respiratory support. 

Abnormal Sodium Levels Predict Risk of Mortality, Need for Ventilatory Support in COVID-19 Patients

New research from a team led by investigators at the National Institutes of Health (NIH) suggests obesity could impact 

An analysis of 90 girls aged 8-15 years, results of the analysis suggest girls with greater amounts of total body fat saw the timing of puberty, presence of reproductive hormone levels, and development of reproductive organs develop at a different rate than their counterparts

"We found that in mid- to late puberty, girls with greater total body fat demonstrated higher levels of some reproductive hormones including follicle-stimulating hormone (FSH), inhibin B and male-like hormones such as testosterone. In some girls with higher total body fat, higher testosterone levels were associated with irregular menstrual cycles, acne and excess body hair," said lead investigator Natalie D. Shaw, MD, of the National Institute of Environmental Health Sciences (NIEHS) part of the NIH, 

While previous epidemiologic studies demonstrating obese girls experience thelarche and menarche earlier than girls of normal weight, investigators noted no studies have investigated how bodyweight impacts clinical and biochemical pubertal biomarkers in this patient population. With this in mind, Shaw and a team of colleagues from the NIH and the Centers for Disease Control and Prevention (CDC) designed the current study to further investigate this transition in girls from the Triangle region of North Carolina.

For inclusion in the study, investigators recruited pre-menarchal subjects with no chronic medical conditions, free from any medications or supplements that might impact puberty, and had no history of precocious puberty or premature pubarche. Additionally, subjects were required to be free from signs of hyperandrogenism. With enrollment taking place between January 2016-September 2020, investigators identified 80 girls for inclusion in their study.

As part of the study protocol, all patients were required to complete at least 1 study visit spaced approximately 8 months apart—the mean number of study visits per person was 2.8±1.7These visits included a complete physical exam with Tanner staging of the breast and pubic hair, breasts ultrasound for breast morphological statin (B-MORPH), and blood and urine collection. Additionally, monarchal status was determined at each study visit and every 3 months by phone until September 2020.

For the purpose of analysis, associations between the aforementioned factors and total body fat were tested using mixed, multi-state, or Cox proportional hazards models adjusted for baseline BMOPRH.

At baseline, normal weight girls were older than overweight or obese girls (11.3 vs 10.2; 

 <.01) at baseline and had more advanced BMOPRH (

 <.01). Results of the investigators’ initial analyses suggest luteinizing hormone, estradiol, and ovarian and uterine volumes increased with time and total body fat appeared to have no effect on this.

Investigators noted an interaction time-total body fat interaction for follicle-stimulating hormone, inhibin B, estrone, total and free testosterone, and androstenedione. In this interaction, levels were initially similar but increased in girls with higher total body fat, plateaued in girls with mod-range total body fat, and decreased in girls with lower total body fat at 1 year. Additionally, results indicated girls with higher total body fat appeared to progress through BMOPRH stage D more lowly but did achieve menarche earlier than girls with lower levels of total body fat.

"In late puberty, girls with greater body fat also showed delayed breast maturation, as determined by breast ultrasound, and earlier menarche. There were no differences in maturation of the ovaries or uterus as a function of body fat,” added Shaw.

Longitudinal investigation of pubertal milestones and hormones as a function of body fat in girls

A study of 80 young women is providing clinicians with insight into how total body fat can impact the timing of puberty and levels of pubertal hormones in women. 

Excess Body Fat Impacts Puberty Timing In Young Women

Data from a 12-week trial of aging men on testosterone therapy suggests testosterone therapy had no beneficial effect on vascular health or function.

While some have theorized testosterone therapy could counteract the effects of aging on arteries, results of the trial indicate improvements in artery health and function were linked to increased physical activity and not testosterone therapy.

"The global increase in testosterone use has been very large, particularly among middle-aged and older men who might see it as a restorative hormone to increase energy and vitality," said lead investigator Daniel J. Green, PhD, Winthrop Professor and cardiovascular exercise physiology researcher in the School of Human Sciences at The University of Western Australia in Perth, 

. "However, previous studies are mixed as to whether replacement testosterone is beneficial or not, or whether it provides additional benefit over and above the effects of an exercise program."

With an interest in further understanding the effects of testosterone therapy in aging men, Green and a team of colleagues designed the current study to assess the impact of testosterone versus exercise training on endothelium-dependent flow-mediated dilation percentage and endothelium-independent glyceryl trinitrate percent responses. Designed as a 2x2 factorial randomized controlled trial, the 12-week study enrolled 80 men between 50-70 years of age with a waist girth of 95 centimeters or more and low to normal serum testosterone levels.

In total, 78 patients were included in the final analysis and underwent randomization. Of these 78, 21 were randomized to topical testosterone and a strutted exercise program, 18 were randomized to testosterone with no exercise, 20 were randomized to placebo therapy and no exercise, and 19 were randomized to placebo therapy with exercise. Of note, those randomized to testosterone therapy received 5% testosterone cream.

Investigators pointed out prescreening questionnaires allowed for the exclusion of patients based on smoking status, history of cardiovascular disease, and other factors. Additional inclusion criteria included having a fasting serum total testosterone of 6-14 nmol/L, a total cholesterol of 7 mmol/L or more, and a minimum eGFR of 45 ml/min.

Upon analysis, results indicated serum testosterone levels increased beyond 14 nmol/L among 62% of those randomized to testosterone therapy. Results also indicated exercise training was associated with increased flow-mediated dilation percent (

=.033; testosterone and exercise: +0.5, placebo and exercise: +1.0 versus testosterone and no additional exercise: −0.7, placebo and no additional exercise: +0.2%), while this effect was not apparent among those receiving testosterone therapy and it was not additive to exercise (

Additionally, there were no significant exercise or drug main effects on glyceryl trinitrate responses (

 >.05). Further analysis suggested exercise training was associated with improved endothelium-dependent vasodilator function, but testosterone therapy did not appear to influence flow-mediated dilation percent or add to the benefit of exercise. Investigators highlighted vascular smooth muscle sensitivity to nitric oxide was not modified by exercise, testosterone, or their combination.

“The results of our study suggest that if you are a healthy but relatively inactive middle-aged or older man with increased abdominal girth, and you are worried about your risk of heart attack, stroke or diabetes, then an exercise program with some support and supervision can help to improve the function and health of your arteries,” Green said. “Testosterone therapy may have some benefits, for example in increasing muscle mass in the legs, however, we didn’t find any benefits in terms of artery function, which is a determinant of future cardiovascular risk.”

Testosterone and Exercise in Middle-to-Older Aged Men

An analysis of data from a 12-week trial in overweight men on testosterone therapy is providing insight into the potential effect of testosterone therapy on vascular health and function. 

Analysis Finds Testosterone Therapy Provides No Benefit on Vascular Function

An analysis of more than 3 dozen studies examining behavioral 

 interventions has returned positive evidence in support of using digital tools for self-monitoring.

Results of the systematic review outline the potential usefulness of these new technologies by providing evidence suggesting more than 70% of patients using digital self-monitoring technologies experienced weight loss and also finding rates of engagement were greater with digital rather than manual self-monitoring in 21 of 34 comparisons.

"Digital health tools have flourished in the past decade," said Michele L. Patel, PhD, post-doctoral research fellow, Stanford Prevention Research Center, Stanford University School of Medicine, 

."What this paper sought out to explore was whether tracking via these digital tools is effective at producing greater weight loss."

With the obesity epidemic expected to expand its foothold in the US and other countries, Patel, Lindsay Wakayama, PhD, and Gary Bennet, MD, sought to evaluate how digital monitoring is being used and whether use was associated with weight loss. To do so, investigators designed the current study as a systematic review of studies examining digital self-monitoring in behavioral weight loss interventions from randomized clinical trials within the PubMed, Embase, Scopus, PsycInfo, CINAHL, and ProQuest Dissertations & Theses databases.

For inclusion in the review, studies needed to be designed as randomized controlled trials, examine interventions lasting at least 12 weeks, report weight outcomes 6 months after baseline, and include outcomes on self-monitoring engagement and their relationship to weight loss. Eligible trials were required to enroll adult patients aged 18 years or older and be published between 2009-2019. The initial search yielded 4248 records. After application of the inclusion criteria, a total of 53 papers describing 39 unique randomized trials were identified for inclusion.

These 39 trials included 8232 patients with a mean age ranging from 29-56 years. The mean baseline BMI among these studies ranged from 28.3-37.0 kg/m2. Most of the trials were conducted in the US and the duration of interventions ranged from 3-24 months, with a median of 6 months.

In total, 67 interventions using digital self-monitoring were identified within the 39 trials—weight was tracked 72% percent of interventions with digital self-monitoring, diet was tracked in 81%, and physical activity was tracked in 82%. The most common medium of self-monitoring was websites and other common mediums included apps, wearables, electronic scales, and text messaging.

"This may be because many digital tools are highly portable, and therefore allow the user to track any time of the day; digital tools also may make tracking quicker, and may be less burdensome to use," added Patel.

Results of the investigators’ analysis indicated few interventions had engagement rates of 75% or more of the study days. Additionally, results suggested rates of engagement were greater with digital- rather than paper-based arms in 21 out of 34 comparisons and lower in only 2 comparisons. When assessing impact of self-monitoring adherence, investigators found greater digital self-monitoring was associated with weight loss in 74% of occurrences.

Self-Monitoring via Digital Health in Weight Loss Interventions: A Systematic Review Among Adults with Overweight or Obesity

A review of 39 randomized clinical trials examining weight loss interventions is providing clinicians with an overview of engagement rates, mediums used, and effects of digital self-monitoring for weight loss among obese or overweight patients.