Hypogonadotropic Hypogonadism in Obese Young Males
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Serum Free Testosterone
研究概览
简要总结
Obesity can lead to low testosterone concentrations in young men. This study will study the effects of low testosterone in those men and the result of treating them with clomiphene.
详细描述
The prevalence of obesity has increased in children over the past few decades. Approximately 20% of adolescent boys are now considered obese. It is well accepted that obese children are at increased risk for high blood pressure, lipid abnormalities and type 2 diabetes. Recent studies have uncovered yet another undesirable effect of obesity. The testosterone levels of obese boys are only half those of lean boys at completion of puberty. Testosterone is important for muscle and bone development. Men with low testosterone are at higher risk of insulin resistance and inflammation, which lead to type 2 diabetes and heart disease. Since testosterone is the major reproductive hormone, these obese boys are at risk of decreased fertility. Men are supposed to achieve their peak testosterone levels at puberty. Thereafter, there is a decline in testosterone levels at the rate of 2% per year for the rest of life. Thus there is a clear need to develop a deeper understanding of low testosterone in these males who are entering their peak fertility years. There are no approved treatments for this disorder. The investigators propose to conduct a randomized placebo controlled trial to evaluate the effect of treatment with clomiphene in obese young men(age 18-30 years) who have low testosterone concentrations. Clomiphene is a drug that increases testosterone concentrations and possibly increases sperm production. In contrast, testosterone replacement therapy decreased fertility and cannot be used in young men. Investigators will study the effect of treatment with clomiphene or placebo tablets for 12 weeks in 30 subjects. The study will evaluate:-
- testicular function: Testosterone and two proteins secreted by testis(insulin like factor 3 and inhibin B) will be measured in the blood before and after treatment with clomiphene or placebo.
- insulin resistance: Investigators will measure insulin and glucose levels in the blood.
- inflammation: Investigators will measure proteins that induce inflammation.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18-30 years inclusive will be recruited.
- •A total of 90 males will be recruited:-
- •30 obese males (defined as BMI ≥30 kg/m2) with HH,
- •30 obese males with normal FT concentrations and
- •30 lean males (defined as BMI <25 kg/m2) with normal FT concentrations.
排除标准
- •Use of androgens, clomiphene, hCG, aromatase inhibitors or over the counter health supplements which contain androgens currently or in the past 6 months
- •Hematocrit > 50%
- •Congestive heart failure
- •currently suffering from depression
- •type 1 diabetes
- •Hepatic disease (transaminase > 3 times normal) or cirrhosis
- •Renal impairment (eGFR<30 ml/min/1.73m2)
- •HIV or Hepatitis C positive status
- •Participation in any other concurrent clinical trial
- •currently suffering from foot ulcer, significant periodontal disease or any other chronic infectious condition
研究组 & 干预措施
Obese males with hypogonadism-active
Subjects will be randomized to receive clomiphene capsules
干预措施: Clomiphene (Drug)
Obese males with hypogonadism-placebo
Subjects will be randomized to receive placebo capsules
干预措施: Placebo (Drug)
结局指标
主要结局
Serum Free Testosterone
时间窗: 12 weeks
after clomiphene or placebo treatment
次要结局
未报告次要终点
研究者
Sandeep Singh Dhindsa, M.D., F.A.C.E
Professor
St. Louis University