Mediation analysis of the testosterone treatment effect to prevent type 2 diabetes in the Testosterone for Prevention of Type 2 Diabetes Mellitus trial
Authors' conclusion
At least part of the testosterone treatment effect was found to be mediated by changes in fat mass, abdominal fat, skeletal muscle mass, grip strength, SHBG, and E2, but predominantly by changes in fat mass.
Study context
- Population
- Males aged 50–74 years, waist circumference ≥95 cm, serum total testosterone ≤14 nmol/L, with impaired glucose tolerance or newly diagnosed T2D on oral glucose tolerance test (OGTT); 6 Australian tertiary care centres709 with complete data
- Participants
- 1,007 males
- Comparison
- Testosterone undecanoate vs placebo
- Primary endpoint
- T2D (OGTT ≥ 11.1 mmol/L) and change in 2-h glucose from baseline; mediation by changes in fat mass, % abdominal fat, skeletal muscle mass, hand-grip strength, E2 and sex hormone-binding globulin (SHBG)
- Follow-up
- 2 years
Methodological detailsmediation analysis, placebo-controlled, multicentre
- Mediation analysis
- Placebo-controlled
- Multicentre
Primary result
As reported in the abstract
T2D (OGTT ≥ 11.1 mmol/L): mediation of the treatment effect
- Unadjusted OR for treatment
- 0.53 (95% CI:.35-.79)
- OR for treatment after adjustment for covariates
- 0.48 (95% CI:.30-.76)
- OR for treatment including potential mediators (direct effect)
- 0.77 (95% CI:.44-1.35)
- Proportion of treatment effect mediated
- 65%
- Fat mass, the only mediator prognostic in the full model: OR
- 1.23 (95% CI: 1.09-1.39; P < .001)
Further findings
Fat mass as prognostic factor for T2D in full model · 2 years
- Fat mass OR (only mediator remaining prognostic)
- 1.23 (95% CI: 1.09-1.39; P < .001)
Original publication
Mediation analysis of the testosterone treatment effect to prevent type 2 diabetes in the Testosterone for Prevention of Type 2 Diabetes Mellitus trial. Eur J Endocrinol. Published 5 July 2023. doi:10.
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