Type 2 & other diabetes

Long-term Outcomes of Testosterone Treatment in Men: A T4DM Postrandomization Observational Follow-up Study

J Clin Endocrinol MetabPublished Postrandomization observational follow-up study of the T4DM randomised trial

Authors' conclusion

We conclude that randomized T treatment for 24 months in men with impaired glucose tolerance or new diabetes but without pathological hypogonadism was associated with higher levels of self-reported benefits and diagnosis of sleep apnea during, but not after, the study as well as more frequent prescribed poststudy T treatment consistent with androgen dependence in some men receiving prolonged injectable TU.

Study context

Population
Men with impaired glucose tolerance or newly diagnosed diabetes randomized in T4DM (1007 men)59% completed surveys
Participants
599 men
Comparison
Testosterone undecanoate vs placebo
  • Testosterone undecanoate (TU)n = 316
  • Pn = 283reference
Methodological detailsemail survey, Follow-up email survey after a median of 5.1 years since last injection
  • Email survey
  • Follow-up email survey after a median of 5.1 years since last injection

Primary result

As reported in the abstract

Belief in study benefits

P < 0.001

Further findings

Belief in study benefits

P = 0.07

Resuming prescribed T treatment · poststudy

P = 0.03

Self-reported new diabetes, prostate or CVD; weight maintenance or weight loss behaviors · 5 years after cessation

No difference in self-reported new diagnosis of diabetes, prostate or CVD, nor change in weight maintenance or weight loss behaviors

Safety

New diagnosis of sleep apnea · during the study

P = 0.03

New diagnosis of sleep apnea — Sleep apnea at T4DM entry
25%

New diagnosis of sleep apnea · during the study

Not more frequent after the study

Original publication

Long-term Outcomes of Testosterone Treatment in Men: A T4DM Postrandomization Observational Follow-up Study. J Clin Endocrinol Metab. Published 25 August 2023. doi:10.1210/clinem/dgad485

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