Effect of Hypogonadotropic Hypogonadism and Replacement With Clomiphene Citrate and Testosterone on Insulin Sensitivity, Body Composition, Inflammation, Sexual Function and Spermatogenesis in Young Type 2 Diabetic Men
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Insulin Resistance
研究概览
简要总结
Low testosterone production, known clinically as hypogonadism, appears to be common complication of type 2 diabetes, affecting one in three diabetic men. Hypogonadism is known to be associated with decreased muscle mass, increased fat mass, increased inflammation and decreased fertility. In this grant, the investigators propose to study the effects of having low testosterone on 1) insulin sensitivity, the ability of the body to handle glucose 2) fat and muscle mass at specific areas of the body 3) expression of mediators of inflammation in the blood 4) semen quality. This study will compare diabetic men (with or without hypogonadism). This study will also evaluate the effect of treatment with clomiphene (a drug that increases testosterone and sperm production) or testosterone in men with diabetes and hypogonadism. The investigators hope that this project will help us understand the state of hypogonadism in young type 2 diabetic men who are in their peak fertility years and give us insights into treatment of this condition. With the rising prevalence of type 2 diabetes in the young, this project may have implications for public health.
详细描述
This project will study young men with type 2 diabetes. We have shown that half of these men have low testosterone levels. This can lead to 1) Low muscle mass; 2) more fat mass; 3) insulin resistance; 4) low sperm count and 5) increased inflammation (that increases the risk of heart disease). This project will study these consequences in detail and also the possibility of reversing them with treatment. Information from this project will be useful in planning of future studies that will evaluate the effect of treatment of low testosterone on mortality, heart disease and stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •T2D Males with age 18-40 years
排除标准
- •planning to have children in the next one year
- •Use of androgens, CC, hCG, aromatase inhibitors or over the counter health supplements which contain androgens currently or in the past 6 months;
- •PSA > 4ng/ml, symptoms of severe BPH, prostate nodule or severe enlargement on digital rectal examination or h/o prostatic carcinoma
- •Hemoglobin A1c > 8%
- •Hematocrit > 50%
- •History of obstructive sleep apnea
- •Congestive heart failure
- •Use of thiazolidinediones or exenatide
- •currently suffering from depression, with or without treatment
- •history of severe depression in the past which needed hospitalization
- •currently suffering from foot ulcer, significant periodontal disease or any other chronic infectious condition
- •Coronary event or procedure in the previous 6 months
- •Hepatic disease (transaminase > 3 times normal) or cirrhosis
- •Renal impairment (serum creatinine > 1.5)
- •HIV or Hepatitis C positive status
- •Participation in any other concurrent clinical trial
研究组 & 干预措施
testosterone
intramuscular injections every 2 weeks
干预措施: testosterone (Drug)
clomiphene
oral drug thrice a week
干预措施: clomiphene (Drug)
placebo for testosterone
placebo for testosterone arm
干预措施: placebo (Drug)
placebo for clomiphene
oral placebo for clomiphene arm
干预措施: placebo (Drug)
结局指标
主要结局
Insulin Resistance
时间窗: 6 months
To compare the insulin sensitivity as measured by whole body glucose uptake during hyperinsulinemic euglycemic (HE) clamp in young T2D men with and without HH.
次要结局
未报告次要终点
研究者
sandeep dhindsa
Assoc Prof of Medicine
State University of New York at Buffalo