Effect of Varying Testosterone Levels on Insulin Sensitivity in Normal and IHH Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- insulin sensitivity
研究概览
简要总结
Type 2 diabetes is one of the most common metabolic disorders in the U.S, estimated to affect 16 million Americans. Established risk factors for this disease include obesity, increased waist/hip ratio, high insulin levels in the blood, and insulin resistance. Testosterone may play a role in developing or preventing diabetes, but we do not yet know for sure. The purpose of this research study is to determine if changing testosterone levels in men will result in changes in insulin sensitivity. Information learned form this research study may have important public health implications and may point to new strategies for treating or preventing diabetes.
详细描述
The overall aim of this study is to examine the effect of testosterone on insulin sensitivity using the models of acute and chronic hypogonadism. All subjects will be in good general health and 2 groups of men will be studied in this protocol:
- Thirty healthy normal men aged 18-75 years with normal blood pressure, normal testosterone levels, and not taking any medications known to influence glucose homeostasis or testosterone
- Ten adult men (over the age of 18) with idiopathic hypogonadotropic hypogonadism (IHH)and normal thyroid, adrenal, and growth hormone axes as well as normal prolactin levels and no abnormalities on imaging of the hypothalamic-pituitary region. These men will be on no medications known to influence glucose homeostasis and will have been off hormone therapy for a suitable washout period depending on the type of prior androgen replacement.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy men:
- •Good general health,
- •Normotensive,
- •Normal testosterone levels,
- •No medications known to influence glucose homeostasis or testosterone levels
- •Good general health;
- •Normal thyroid, adrenal, and GH axes;
- •Normal prolactin levels;
- •No abnormalities on imaging of the hypothalamic-pituitary region;
- •No medications known to influence glucose homeostasis;
- •Must have been off hormone therapy for a suitable washout period depending on the type of prior androgen replacement
排除标准
- 未提供
结局指标
主要结局
insulin sensitivity
时间窗: 2 timepoints: with a normal serum testsoterone and in a castrate state of low serum testoserone
次要结局
- body composition(2 timepoints: with a normal serum testsoterone and in a castrate state of low serum testoserone)