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Testosterone therapy to prevent type 2 diabetes mellitus in at-risk men (T4DM): Design and implementation of a
Gary Wittert1, Evan Atlantis1,2, Carolyn Allan3
1Freemasons Foundation Centre for Mens Health, School of Medicine, University of Adelaide, Adelaide, South Australia, Australia.
Background:
Low circulating testosterone is associated with an increased risk of developing type 2 diabetes (T2DM) in overweight men with impaired glucose tolerance (IGT).
Aims:
To determine in a multi-centre, double-blinded placebo-controlled randomized trial whether testosterone treatment combined with lifestyle intervention (Weight Watchers) relative to lifestyle intervention alone reduces T2DM incidence and improves glucose tolerance at 2 years.
Study Population:
Overweight or obese men aged 50-74 years with a serum testosterone of ≤14 nmol/L and IGT or newly diagnosed T2DM established by an oral glucose tolerance test (OGTT).
Setting, Drug And Protocol:
Six Australian capital city-based tertiary care centres. Participants were randomized 1:1 and injected with testosterone undecanoate (1000 mg/4 mL) or vehicle (4 mL castor oil), at baseline, 6 weeks and 3-monthly thereafter. PRIMARY ENDPOINTS: (a) Proportion of participants with 2-hour OGTT ≥11.1 mmol/L at 2 years, and (b) a difference at 2 years ≥0.6 mmol/L in the mean 2-hour OGTT glucose between treatments.
Secondary Endpoints:
Fasting insulin, HbA1c, body composition, maximal handgrip strength; sexual function and lower urinary tract symptoms; serum sex steroids and sex hormone binding globulin; mood and psychosocial function; adherence to lifestyle intervention; and healthcare utilization and costs.
Safety:
Overseen by an Independent Data Safety Monitoring Committee. Haematocrit, lipids and prostate-specific antigen (PSA) are assessed 6-monthly and information relating to haematological, urological and cardiovascular adverse events from each clinic visit. SUB-STUDIES: (a) Changes in bone density and micro-architecture, (b) motivation and behaviour, (c) telomere length, (d) extended treatment up to 4 years, and (e) hypothalamo-pituitary testicular axis recovery at treatment end.
Insights
Low testosterone increases type 2 diabetes risk in overweight men. Testosterone therapy with lifestyle changes may reduce diabetes incidence and improve glucose tolerance.
Area of Science:
- Endocrinology
- Metabolic Health
- Clinical Trials
Background:
- Low circulating testosterone is linked to higher type 2 diabetes (T2DM) risk in overweight men with impaired glucose tolerance (IGT).
- Understanding the impact of testosterone replacement therapy on T2DM development and glucose metabolism is crucial for this demographic.
Purpose of the Study:
- To evaluate if testosterone treatment combined with lifestyle intervention reduces T2DM incidence compared to lifestyle intervention alone over two years.
- To assess the effect of combined therapy on improving glucose tolerance in overweight men with low testosterone.
Main Methods:
- A multi-centre, double-blinded, placebo-controlled randomized trial involving overweight or obese men aged 50-74 years with low testosterone and IGT or newly diagnosed T2DM.
- Participants received testosterone undecanoate injections or a placebo, alongside a lifestyle intervention (Weight Watchers), with primary endpoints assessed at two years.
Main Results:
- Primary endpoints include the proportion of participants developing T2DM and the difference in mean 2-hour oral glucose tolerance test (OGTT) glucose levels between groups.
- Secondary endpoints encompass changes in fasting insulin, HbA1c, body composition, sexual function, mood, and other health markers.
Conclusions:
- The study aims to provide evidence on the efficacy of testosterone therapy in conjunction with lifestyle changes for T2DM prevention and glucose metabolism improvement.
- Findings will inform clinical practice regarding testosterone management in overweight men at risk for or with established type 2 diabetes.
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