Chillarón Juan J, Fernández-Miró Mercè, Albareda Mercè, Fontserè Sara, Colom Cristina, Vila Lluís, Pedro-Botet Juan, Flores Le-Roux Juana A
Department of Endocrinology and Nutrition, Hospital del Mar, Barcelona, Spain.
Endocr J. 2016 Sep 30;63(9):849-855. doi: 10.1507/endocrj.EJ16-0195. Epub 2016 Jul 22.
Testosterone deficiency (Td) has been associated with the metabolic syndrome. Few studies have evaluated this condition in type 1 diabetes (T1D). The primary aim of this study was to evaluate the effectiveness of testosterone undecanoate (TU) on insulin sensitivity, glycemic control, anthropometric parameters, blood pressure and lipid profile in patients with Td and T1D. We performed a randomized placebo-controlled multicenter study.
a) age ≥ 18 years; b) autoimmune diabetes; c) Td (total testosterone <10 nmol/L or calculated free testosterone <225 pmol/L and low/normal LH; d) ability to sign informed consent; e) comply with the study protocol.
a) pituitary tumor, empty sella, hyperprolactinemia, panhypopituitarism or secondary hypogonadism; b) contraindications for treatment with testosterone undecanoate (TU); c) patients who did not agree to sign their informed consent. Six patients were randomly assigned to testosterone undecanoate (TU) treatment and 7 to placebo with the following dosing schedule: baseline, 6 weeks and 16 weeks. Blood test, anthropometric parameters, blood pressure and insulin sensitivity were determined at baseline, 6, 16 and 22 weeks. No differences were observed regarding insulin sensitivity, HbA or basal glucose, anthropometric parameters or blood pressure. At 22 weeks, the decrease in total cholesterol was 37.4 ± 27.5 mg/dL in the TU group compared with an increase of 13.2 ± 17.8 mg/dL in the placebo group (P<0.005), and LDL cholesterol concentration decreased 30.2 ± 22.1 mg/dL, compared with an increase of 10.5 ± 13.4 mg/dL in the placebo group (P=0.004). We conclude that treatment with TU in patients with T1D and Td improves lipid profile, with no effects on metabolic control or anthropometric parameters.
睾酮缺乏（Td）与代谢综合征有关。很少有研究评估1型糖尿病（T1D）患者的这种情况。本研究的主要目的是评估十一酸睾酮（TU）对Td和T1D患者胰岛素敏感性、血糖控制、人体测量参数、血压和血脂谱的有效性。我们进行了一项随机安慰剂对照多中心研究。
a）年龄≥18岁；b）自身免疫性糖尿病；c）Td（总睾酮<10 nmol/L或计算的游离睾酮<225 pmol/L且促黄体生成素低/正常）；d）有能力签署知情同意书；e）遵守研究方案。
a）垂体瘤、空蝶鞍、高泌乳素血症、全垂体功能减退或继发性性腺功能减退；b）十一酸睾酮（TU）治疗的禁忌症；c）不同意签署知情同意书的患者。6名患者被随机分配接受十一酸睾酮（TU）治疗，7名患者接受安慰剂治疗，给药方案如下：基线、6周和16周。在基线、6周、16周和22周时测定血液检查、人体测量参数、血压和胰岛素敏感性。在胰岛素敏感性、糖化血红蛋白或基础血糖、人体测量参数或血压方面未观察到差异。在22周时，TU组总胆固醇降低37.4±27.5 mg/dL，而安慰剂组增加13.2±17.8 mg/dL（P<0.005），低密度脂蛋白胆固醇浓度降低30.2±22.1 mg/dL，而安慰剂组增加10.5±13.4 mg/dL（P=0.004）。我们得出结论，T1D和Td患者使用TU治疗可改善血脂谱，对代谢控制或人体测量参数无影响。
