Reproductive endocrinology

Testosterone therapy reduces insulin resistance in men with adult‐onset testosterone deficiency and metabolic syndrome. Results from the Moscow Study, a randomized controlled trial with an open‐label phase

Diabetes Obes MetabPublished Randomised controlled trial with an open-label phase

Authors' conclusion

Baseline HOMA-IR predicted ΔHOMA-IR, with a greater percentage change in insulin than in fasting glucose. In men with MetS/type 2 diabetes (T2DM) not on antiglycaemic therapy, improvements in HOMA-IR may be greater than suggested by change in fasting glucose. Our results suggest that hypogonadism screening be included in the management of men with MetS/T2DM.

Study context

Population
Men with metabolic syndrome and hypogonadism; analysis focused on men not receiving antiglycaemic agents (TU: 81; placebo: 54)randomized
Participants
184 men
Comparison
Testosterone undecanoate vs placebo
  • TUn = 113
  • Placebon = 71reference
Primary endpoint
Change in HOMA-IR
Methodological detailsplacebo-controlled, double-blind, open-label phase with TU for all
  • Placebo-controlled
  • Double-blind
  • Open-label phase with TU for all

Primary result

As reported in the abstract

Median HOMA-IR vs baseline · almost every time point after 18 weeks
  • Median HOMA-IR significantly reduced vs baseline with TU in both study and confirmatory cohorts
  • Placebo not associated with significant ∆HOMA-IR

Further findings

Median fasting glucose change after TU

30 weeks
−2.1%
138 weeks
−4.9%
  • Significant decrease

Median insulin change after TU

30 weeks
−10.5%
138 weeks
−35.5%
  • Significant decrease

Predictors of HOMA-IR decrease after TU

Only consistent predictor: baseline HOMA-IR (r2)
≥ 0.64

Original publication

Testosterone therapy reduces insulin resistance in men with adult‐onset testosterone deficiency and metabolic syndrome. Results from the Moscow Study, a randomized controlled trial with an open‐label phase. Diabetes Obes Metab. Published 3 March 2024. doi:10.1111/dom.15520

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