The T4DM trial was a 2-year randomised controlled trial of testosterone treatment for men with impaired glucose tolerance or newly diagnosed type 2 diabetes and serum testosterone concentrations below 14 nmol/l but without pathological hypogonadism. All participants were enrolled in a lifestyle program during the trial.
The primary outcomes of the trial, published in 2021, were type 2 diabetes and change in blood glucose, from 2-hour oral glucose tolerance test. Men in the testosterone treatment group had a 40% lower prevalence of diabetes, and a greater reduction in blood glucose level, than men in the placebo group. Treatment-limiting increases in haematocrit (to above 54%) occurred in 22% of men in the testosterone group but only in 1% of the placebo group.
This secondary analysis of data from the T4DM trial uses data from 64% of participants, who completed questionnaires to assess health-related quality of life (HR-QOL) and various aspects of psychosocial function. Overall, most measures were not different between testosterone and placebo groups.
Subjective social status and sense of coherence (view of one’s life and ability to mobilise resources to maintain and improve health) were transiently higher for men in the treatment group than the placebo group but this effect did not persist until the end of the study.
In highlighting their main findings, the authors state, “irrespective of treatment status (testosterone or placebo), improvement in mental wellbeing was associated with changes in body weight during the RCT, meaning that larger decreases in body weight were associated with better self-reported mental quality of life”. They conclude that their analyses “lend support for prioritising weight loss induced by lifestyle change in the context of exposure to a lifestyle program – rather than testosterone therapy per se – for improving HR-QOL and psychosocial functioning”.
