Effects of Replacement Therapy With Sexual Steroid Hormones on the Insulin Sensitivity of Hypogonadal Man
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- GIR (glucose infusion rate) during euglycemic hyperinsulinemic clamp
研究概览
简要总结
Sexual steroids administered to supra-physiological doses are likely to change the carbohydrate and lipid metabolism.
Investigators propose to study in 12 hypogonadal men hypogonadotropic or hypergonadotropic treated with aromatase inhibitor, the respective effects of estradiol, testosterone or both steroids administered in a cross-over Latin squares plan on insulin sensitivity measured by the reference method of the hyperinsulinemic euglycemic clamp.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Hypogonadism hypogonadotropic or hypergonadotropic
- •Man aged 18-60 years
- •BMI between 18 and 27.
排除标准
- •Other ante-pituitary deficiency
- •Chronic treatment modifying carbohydrate metabolism (thiazides, beta 2 mimetics, steroids ...)
- •Obesity diffuse or android
- •Hemochromatosis
- •osteoporosis
- •chronic diseases
- •neoplasia
- •High blood pressure
研究组 & 干预措施
Estradiol
dosage used in the study: 1 patch / 3-4 days dosed at 25, 37.5 or 50 mg / 24h titration according to the plasma level, with the objective of a physiological level of estradiol (25-40 pg / ml ) - During 4 weeks
干预措施: Estradiol (Insulin sensitivity) (Biological)
Testosterone
dosage used : from 25 to 75 mg / day of testosterone (ie 2.5 to 7.5 g / day transdermal gel) according to the plasma level, with the goal of a physiological level of testosterone (5-8 ng / ml) - During 4 weeks
干预措施: Testosterone (Insulin sensitivity) (Biological)
Testosterone + Estradiol
Testosterone + Estradiol During 4 weeks
干预措施: Estradiol (Insulin sensitivity) (Biological)
Testosterone + Estradiol
Testosterone + Estradiol During 4 weeks
干预措施: Testosterone (Insulin sensitivity) (Biological)
结局指标
主要结局
GIR (glucose infusion rate) during euglycemic hyperinsulinemic clamp
时间窗: change between baseline and after 4 weeks of treatments
次要结局
未报告次要终点