Department of Endocrinology, Medical Clinic K-medicine, Moscow, Russia.
Department of Endocrinology, People's Friendship University of Russia, Moscow, Russia.
Diabetes Obes Metab. 2024 Jun;26(6):2147-2157. doi: 10.1111/dom.15520. Epub 2024 Mar 3.
To describe changes in homeostasis model assessment of insulin resistance index (HOMA-IR) following testosterone therapy in men with hypogonadism and metabolic syndrome (MetS).
A randomized, placebo-controlled, double-blind randomized controlled trial (RCT) comprising 184 men with MetS and hypogonadism (testosterone undecanoate [TU]: 113 men, placebo: 71 men) was conducted. This was followed by an open-label phase in which all men were given TU. We focused on men who were not receiving antiglycaemic agents (TU: 81 men; placebo: 54 men) as these could affect HOMA-IR. Inter-group comparison of HOMA-IR was restricted to the RCT (30 weeks), whilst intra-group comparison was carried out on men provided TU during the RCT and open-label phases (study cohort) and men given placebo during the RCT and then switched to TU during the open-label phase (confirmatory cohort). Regression analysis was performed to identify factors associated with change in HOMA-IR (∆HOMA-IR).
The median HOMA-IR was significantly reduced at almost every time point (after 18 weeks) compared to baseline in men receiving TU in both the study and confirmatory cohorts. There was a significant decrease in median values of fasting glucose (30 weeks: -2.1%; 138 weeks: -4.9%) and insulin (30 weeks: -10.5%; 138 weeks: -35.5%) after TU treatment. Placebo was not associated with significant ∆HOMA-IR. The only consistent predictor of HOMA-IR decrease following TU treatment was baseline HOMA-IR (r ≥ 0.64).
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.
描述患有代谢综合征（MetS）和性腺功能减退症的男性在接受睾丸素治疗后，胰岛素抵抗指数（HOMA-IR）的稳态模型评估（HOMA-IR）的变化。
进行了一项随机、安慰剂对照、双盲随机对照临床试验（RCT），共纳入 184 名患有 MetS 和性腺功能减退症的男性（十一酸睾酮[TU]：113 名男性，安慰剂：71 名男性）。随后，所有男性均接受了 TU 治疗。我们将重点放在未接受抗糖药物治疗的男性（TU：81 名男性；安慰剂：54 名男性）上，因为这些药物可能会影响 HOMA-IR。对 HOMA-IR 的组间比较仅限于 RCT（30 周），而对 RCT 和开放标签阶段接受 TU 治疗的男性（研究队列）和在 RCT 期间接受安慰剂治疗但随后在开放标签阶段切换至 TU 治疗的男性（验证队列）进行组内比较。进行回归分析以确定与 HOMA-IR 变化相关的因素（∆HOMA-IR）。
在研究和验证队列中，接受 TU 治疗的男性在几乎每个时间点（18 周后）与基线相比，HOMA-IR 均显著降低。在 TU 治疗后，空腹血糖（30 周：-2.1%；138 周：-4.9%）和胰岛素（30 周：-10.5%；138 周：-35.5%）的中位数显著降低。安慰剂与 HOMA-IR 的显著降低无关。TU 治疗后 HOMA-IR 降低的唯一一致预测因素是基线 HOMA-IR（r≥0.64）。
基线 HOMA-IR 预测了 ∆HOMA-IR，胰岛素的变化百分比大于空腹血糖。在未接受抗糖治疗的 MetS/2 型糖尿病（T2DM）男性中，HOMA-IR 的改善可能大于空腹血糖变化所提示的。我们的研究结果表明，应将性腺功能减退症筛查纳入 MetS/T2DM 男性的管理中。
