Abstract

The primary outcome of the TIMES2 study was to determine if testosterone replacement improved insulin resistance in hypogonadal men with metabolic syndrome and/or type 2 diabetes. There is substantial evidence that hypogonadism is associated with reduced insulin sensitivity and that testosterone replacement increases sensitivity as assessed by hyperinsulinemic-euglycemic clamp and homeostasis model assessment of insulin (HOMA-IR). TIMES2 showed a significant benefit on reduction in insulin resistance (−15%), similar to that reported with metformin. Changes in HOMA-IR in the per-protocol group did not reach significance, but in the type 2 diabetes cohort after 12 months approached significance ( P = 0.067; n = 50). In the total modified per-protocol population, changes in HOMA-IR almost reached significance at 6 ( P …

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