The Robert Hague Centre for Diabetes and Endocrinology, Barnsley Hospital, Barnsley, UK.
Diabetes Care. 2011 Apr;34(4):828-37. doi: 10.2337/dc10-1233. Epub 2011 Mar 8.
This study evaluated the effects of testosterone replacement therapy (TRT) on insulin resistance, cardiovascular risk factors, and symptoms in hypogonadal men with type 2 diabetes and/or metabolic syndrome (MetS).
The efficacy, safety, and tolerability of a novel transdermal 2% testosterone gel was evaluated over 12 months in 220 hypogonadal men with type 2 diabetes and/or MetS in a multicenter, prospective, randomized, double-blind, placebo-controlled study. The primary outcome was mean change from baseline in homeostasis model assessment of insulin resistance (HOMA-IR). Secondary outcomes were measures of body composition, glycemic control, lipids, and sexual function. Efficacy results focused primarily on months 0-6 (phase 1; no changes in medication allowed). Medication changes were allowed in phase 2 (months 6-12).
TRT reduced HOMA-IR in the overall population by 15.2% at 6 months (P = 0.018) and 16.4% at 12 months (P = 0.006). In type 2 diabetic patients, glycemic control was significantly better in the TRT group than the placebo group at month 9 (HbA(1c): treatment difference, -0.446%; P = 0.035). Improvements in total and LDL cholesterol, lipoprotein a (Lpa), body composition, libido, and sexual function occurred in selected patient groups. There were no significant differences between groups in the frequencies of adverse events (AEs) or serious AEs. The majority of AEs (>95%) were mild or moderate.
Over a 6-month period, transdermal TRT was associated with beneficial effects on insulin resistance, total and LDL-cholesterol, Lpa, and sexual health in hypogonadal men with type 2 diabetes and/or MetS.
本研究评估了睾丸激素替代疗法（TRT）对 2 型糖尿病和/或代谢综合征（MetS）伴性腺功能减退男性的胰岛素抵抗、心血管风险因素和症状的影响。
在一项多中心、前瞻性、随机、双盲、安慰剂对照研究中，220 例 2 型糖尿病和/或 MetS 伴性腺功能减退男性接受了为期 12 个月的新型 2%透皮睾酮凝胶的疗效、安全性和耐受性评估。主要结局是从基线到稳态模型评估的胰岛素抵抗（HOMA-IR）的平均变化。次要结局是身体成分、血糖控制、血脂和性功能的测量。疗效结果主要集中在 0-6 个月（第 1 阶段；不允许改变药物）。在第 2 阶段（6-12 个月）允许改变药物。
TRT 在整个人群中，6 个月时 HOMA-IR 降低了 15.2%（P=0.018），12 个月时降低了 16.4%（P=0.006）。在 2 型糖尿病患者中，TRT 组的血糖控制在第 9 个月显著优于安慰剂组（HbA1c：治疗差异，-0.446%；P=0.035）。在选定的患者组中，总胆固醇和 LDL 胆固醇、脂蛋白 a（Lpa）、身体成分、性欲和性功能得到改善。两组之间不良事件（AE）或严重 AE 的发生率无显著差异。大多数 AE（>95%）为轻度或中度。
在 6 个月的时间内，透皮 TRT 与 2 型糖尿病和/或 MetS 伴性腺功能减退男性的胰岛素抵抗、总胆固醇和 LDL 胆固醇、Lpa 和性健康的有益影响相关。
