Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change in glucose tolerance
研究概览
简要总结
The investigators are doing this research study to look at the relationship between testosterone (the main sex hormone in men) and insulin (the hormone that controls blood sugar levels) in men with Idiopathic Hypogonadotropic Hypogonadism (IHH).
The investigators hypothesize that normalizing testosterone levels in men with IHH enhances insulin sensitivity, reduces visceral fat, increases lean body mass, and improves the lipid profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic hypogonadotropic hypogonadism or Kallmann Syndrome
- •mean testosterone level less than 300 ng/dl
- •stable weight for the previous 3 months (no weight change greater than or equal to 10 lbs)
- •normal serum TSH
- •normal serum prolactin levels
排除标准
- •Type 2 diabetes mellitus
- •history of diabetes in parents
- •sleep apnea
- •bleeding disorder
- •seeking fertility
- •2 or more cardiovascular risk factors: smoking, hypertension, diabetes, dyslipidemias, family history of cardiovascular disease before age
- •history of previous cardiovascular event: myocardial infarction, unstable angina, cerebro-vascular accident.
- •illicit drug use/alcohol use (>4 drinks per day)
研究组 & 干预措施
Androgen only addback
Anastrozole 10 mg orally once daily for 3 months Testosterone gel 7.5 g transdermally daily for 3 months.
干预措施: Anastrozole Pill (Drug)
Androgen only addback
Anastrozole 10 mg orally once daily for 3 months Testosterone gel 7.5 g transdermally daily for 3 months.
干预措施: Testosterone (Drug)
Combined sex steroid addback
Placebo (sugar pill) tablet once daily for 3 months Testosterone gel 7.5 g transdermally daily for 3 months.
干预措施: Testosterone (Drug)
Combined sex steroid addback
Placebo (sugar pill) tablet once daily for 3 months Testosterone gel 7.5 g transdermally daily for 3 months.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Change in glucose tolerance
时间窗: Change between baseline and 3 months
Response to 75 g glucose load
Change in insulin sensitivity
时间窗: Change between baseline and 3 months
IV glucose tolerance test
次要结局
- Change in visceral fat(Change between baseline and 3 months)
- Change in resting energy expenditure(Change between baseline and 3 months)
研究者
Frances Hayes
Associate Professor
Massachusetts General Hospital