Objective

We evaluated long-term effects of testosterone undecanoate on glycemic control, metabolic syndrome, vascular function and morphology in obese men with functional hypogonadism (FH) and type 2 diabetes (T2D) in a 2-year prospective clinical trial.

Methods

A total of 55 participants were enrolled in this study; group P (n = 27) received placebo during first and testosterone therapy (TTh) during second year, group T (n = 28) received TTh both years. We pooled results after 1 year of TTh to obtain more statistical power. Results for group T after 2 years of TTh are also presented. We evaluated wide assortment of biochemical (fasting plasma glucose—FPG, glycated hemoglobin—HbA1c and lipid profile), hormonal, vascular (flow-mediated dilatation—FMD and intima-media thickness—IMT), anthropometrical and derived parameters (BMI, HOMA-IR, non-HDL cholesterol, bioavailable and calculated free testosterone). Quality of life was assessed using Aging Males’ Symptoms (AMS) questionnaire.

Results

FPG, HbA₁c, HOMA-IR and IMT decreased, FMD increased, lipid profile and AMS sexual sub-score improved, and testosterone levels fully normalized after 2 years of TTh.

Conclusions

Two-year of TTh resulted in normalized serum testosterone levels, improved glycemia, endothelial function, lipids and insulin sensitivity, and quelled the symptoms of hypogonadism, potentially reducing cardiovascular risk in obese men with FH and T2D.

中文翻译：

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睾酮治疗超过 1 年对功能性性腺机能减退和相关代谢、血管、糖尿病和肥胖参数（2 年临床试验的结果）显示出更多影响。

客观的

我们在一项为期 2 年的前瞻性临床试验中评估了十一酸睾酮对患有功能性性腺机能减退 (FH) 和 2 型糖尿病 (T2D) 的肥胖男性的血糖控制、代谢综合征、血管功能和形态的长期影响。

方法

共有 55 名参与者参加了这项研究；P 组（n  = 27）在第一年接受安慰剂，在第二年接受睾酮治疗（TTh），T 组（n  = 28）两年都接受 TTh。我们在 TTh 1 年后汇总结果以获得更多的统计功效。还提供了 TTh 2 年后 T 组的结果。我们评估了各种生化（空腹血糖-FPG、糖化血红蛋白-HbA1c 和血脂）、激素、血管（流动介导的扩张-FMD 和内膜中层厚度-IMT）、人体测量学和衍生参数（BMI、HOMA- IR、非 HDL 胆固醇、生物​​可利用和计算的游离睾酮）。使用老年男性症状 (AMS) 问卷评估生活质量。

结果

FPG、HbA ₁ c、HOMA-IR 和 IMT 下降，FMD 增加，血脂和 AMS 性子评分改善，睾酮水平在 TTh 2 年后完全正常化。

结论

两年的 TTh 使血清睾酮水平正常化，改善了血糖、内皮功能、脂质和胰岛素敏感性，并平息了性腺机能减退的症状，有可能降低患有 FH 和 T2D 的肥胖男性的心血管风险。