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Randomized Controlled Trial
. 2024 Jul 12;109(8):2019-2028.
doi: 10.1210/clinem/dgae085.

Testosterone Treatment, Weight Loss, and Health-related Quality of Life and Psychosocial Function in Men: A 2-year Randomized Controlled Trial

Mathis Grossmann  1   2 , Kristy P Robledo  3 , Mark Daniel  4 , David J Handelsman  5 , Warrick J Inder  6 , Bronwyn G A Stuckey  7 , Bu B Yeap  8 , Mark Ng Tang Fui  1   2 , Karen Bracken  3 , Carolyn A Allan  9 , David Jesudason  10   11 , Jeffrey D Zajac  1   2 , Gary A Wittert  12
Affiliations
Randomized Controlled Trial

Testosterone Treatment, Weight Loss, and Health-related Quality of Life and Psychosocial Function in Men: A 2-year Randomized Controlled Trial

Mathis Grossmann et al. J Clin Endocrinol Metab. .

Abstract

Objective: To determine the effect of testosterone vs placebo treatment on health-related quality of life (HR-QOL) and psychosocial function in men without pathologic hypogonadism in the context of a lifestyle intervention.

Design, setting, participants: Secondary analysis of a 2-year randomized controlled testosterone therapy trial for prevention or reversal of newly diagnosed type 2 diabetes, enrolling men ≥ 50 years at high risk for type 2 diabetes from 6 Australian centers.

Interventions: Injectable testosterone undecanoate or matching placebo on the background of a community-based lifestyle program.

Main outcomes: Self-reported measures of HR-QOL/psychosocial function.

Results: Of 1007 participants randomized into the Testosterone for Type 2 Diabetes Mellitus (T4DM) trial, 648 (64%) had complete data available for all HR-QOL/psychosocial function assessments at baseline and 2 years. Over 24 months, while most measures were not different between treatment arms, testosterone treatment, compared with placebo, improved subjective social status and sense of coherence. Baseline HR-QOL/psychosocial function measures did not predict the effect of testosterone treatment on glycemic outcomes, primary endpoints of T4DM. Irrespective of treatment allocation, larger decreases in body weight were associated with improved mental quality of life, mastery, and subjective social status. Men with better baseline physical function, greater sense of coherence, and fewer depressive symptoms experienced greater associated decreases in body weight, with similar effects on waist circumference.

Conclusion: In this diabetes prevention trial, weight loss induced by a lifestyle intervention improved HR-QOL and psychosocial function in more domains than testosterone treatment. The magnitude of weight and waist circumference reduction were predicted by baseline physical function, depressive symptomology, and sense of coherence.

Keywords: T4DM; psychosocial health; quality of life; testosterone.

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Figures

Figure 1.
Figure 1.
Effect of testosterone treatment on health-related quality of life and psychosocial function measures. Shown are the effects of testosterone and placebo treatment on on health-related quality of life and psychosocial function measures. Data are shown as mean and 95% confidence intervals.
Figure 2.
Figure 2.
Effects of changes in weight on SF-12 MAC2. Shown are effects of changes in weight during the 2-year trial from baseline on SF-12 MAC2 scores at different weeks from randomization. Abbreviations: MAC2, Mental, Mastery, and Subjective Social Status; SF-12, 12-item Short Form Survey.
Figure 3.
Figure 3.
Effects of changes in waist circumference on SF-12 MAC1 and MAC2. Shown are effects of changes in waist circumference during the 2-year trial from baseline on SF-12 MAC1 and MAC2 scores at different weeks from randomisation. Abbreviations: MAC1/2, Mental, Mastery, and Subjective Social Status; SF-12, 12-item Short Form Survey.
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References

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