Metabolic Effects of Testosterone Alone or in Combination With Dutasteride or Anastrazole in Obese Men
试验速览
- 阶段
- 不适用
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- insulin sensitivity
研究概览
简要总结
Subjects will be randomized into 4 study groups: 1. Placebo; 2. Anastrazole and Testosterone; 3. Dutasteride and Testosterone; and 4. Testosterone only. A 2 step euglycemic clamp, body composition by dual X-ray absorptiometry scan, hormone and lipid assays will be performed to monitor metabolic effects of each treatment group. We hypothesize that increasing testosterone levels would increase lean mass, decrease fat mass and improve insulin sensitivity. We further hypothesize that improvements in the metabolic profile would decrease with anastrazole and improve with dutasteride, given in conjunction with T administration.
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
- 24 Years 至 51 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •free T level in the lower 25% of the normal range or below
- •BMI ≥30kg/m2
- •waist circumference ≥100cm
排除标准
- •pituitary tumors
- •HIV infection
- •Klinefelter's syndrome
- •Kallman's syndrome
- •uncontrolled hypertension
- •congestive heart failure
- •chronic lung disease
- •acute coronary syndrome
- •PSA >4µg/L
- •aspartate aminotransferase (AST)> 3x upper limit of normal
- •use of medications that might affect weight loss, muscle or bone metabolism or androgen metabolism, action or clearance.
- •involvement in daily resistance training or high endurance exercise
- •alcohol or drug dependence
- •obstructive sleep apnea
研究组 & 干预措施
Anastrazole and Testosterone
干预措施: Anastrazole (Drug)
Anastrazole and Testosterone
干预措施: Testosterone (Drug)
Anastrazole and Testosterone
干预措施: Dutasteride (Drug)
Anastrazole and Testosterone
干预措施: GnRH antagonist (Drug)
Dutasteride and Testosterone
干预措施: Testosterone (Drug)
Dutasteride and Testosterone
干预措施: Dutasteride (Drug)
Dutasteride and Testosterone
干预措施: GnRH antagonist (Drug)
Testosterone
干预措施: Testosterone (Drug)
Testosterone
干预措施: Dutasteride (Drug)
Testosterone
干预措施: GnRH antagonist (Drug)
结局指标
主要结局
insulin sensitivity
时间窗: 14 weeks
次要结局
- body composition(14 weeks)
- lipid profile(14 weeks)