Type 2 & other diabetes

Effect of Testosterone on Progression From Prediabetes to Diabetes in Men With Hypogonadism: A Substudy of the TRAVERSE Randomized Clinical Trial

JAMA Intern MedPublished Secondary analysis of the TRAVERSE randomised 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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