Effect of Testosterone on Progression From Prediabetes to Diabetes in Men With Hypogonadism: A Substudy of the TRAVERSE Randomized Clinical Trial
Authors' conclusion
In men with hypogonadism and prediabetes, the incidence of progression from prediabetes to diabetes did not differ significantly between testosterone- and placebo-treated men. Testosterone replacement therapy did not improve glycemic control in men with hypogonadism and prediabetes or diabetes. These findings suggest that TRT alone should not be used as a therapeutic intervention to prevent or treat diabetes in men with hypogonadism.
Study context
- Population
- Men aged 45 to 80 years with hypogonadism and prediabetes or diabetes enrolled in TRAVERSE (May 2018–February 2022), 316 US sites1,175 prediabetes · 3880 diabetes
- Comparison
- 1.62% testosterone gel vs placebo gel
- Primary endpoint
- Risk of progression from prediabetes to diabetes (repeated-measures log-binomial regression)
Methodological detailsnested substudy, placebo-controlled, multicentre
- Nested substudy
- Placebo-controlled
- Multicentre
Primary result
As reported in the abstract
Progression from prediabetes to diabetes · 6 to 48 months
- 6 months: Testosterone vs Placebo
- 4 of 598 (0.7%) vs 8 of 562 (1.4%)
- 12 months: Testosterone vs Placebo
- 45 of 575 (7.8%) vs 57 of 533 (10.7%)
- 24 months: Testosterone vs Placebo
- 50 of 494 (10.1%) vs 67 of 460 (14.6%)
- 36 months: Testosterone vs Placebo
- 46 of 359 (12.8%) vs 52 of 330 (15.8%)
- 48 months: Testosterone vs Placebo
- 22 of 164 (13.4%) vs 19 of 121 (15.7%)
Secondary outcomes
Glycemic remission in men with diabetes; changes in glucose and HbA1c
- Glycemic remission and changes in glucose and HbA1c similar with testosterone and placebo
Original publication
Effect of Testosterone on Progression From Prediabetes to Diabetes in Men With Hypogonadism: A Substudy of the TRAVERSE Randomized Clinical Trial. JAMA Intern Med. Published 1 April 2024. doi:10. 1001/ jamainternmed. 2023. 7862
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