An Open Label Study of 5α-reductase Inhibition on the Regulation of Insulin Action and Metabolic Phenotype in Healthy Volunteers.
试验速览
- 阶段
- 2 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- insulin sensitivity
研究概览
简要总结
The purpose of this study is to see if an enzyme in the body (5-alpha reductase, 5αR) is important in controlling how the body handles sugar and fat. The investigators believe that 5αR is a crucial step in regulating these actions as well as controlling how insulin works in the body but regulating the amount of steroid hormones including cortisol and testosterone in the body. In previous clinical studies, the investigators have shown that the activity of 5αR increases as you gain weight and decreases with weight loss. In addition, work that the investigators have performed in the laboratory has shown that if you increase 5αR levels in liver cell grown in the laboratory, the amount of fat that they contain increases. The investigators would therefore like to demonstrate the effect of inhibition 5αR on the regulation of insulin, glucose and fat in the body.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18-65years
- •BMI 20-35kg/m2
- •BMI >35kg/m2
排除标准
- •Diabetes Mellitus
- •Glucocorticoid use within the last 6 months
- •Uncontrolled hypertension (BP>160/100mmHg)
- •Drugs know to impact upon glucocorticoid metabolism
研究组 & 干预措施
Finasteride
Finasteride treatment 5mg for 3 weeks
干预措施: Finasteride (Drug)
Dutasteride
Dutasteride treatment 0.5mg for 3 weeks
干预措施: Dutasteride (Drug)
结局指标
主要结局
insulin sensitivity
时间窗: 3 weeks
stable isotope measurements of glucose production rate and glucose disposal
次要结局
- adipose tissue insulin sensitivity(3 weeks)
研究者
Dr Jeremy Tomlinson
MRC Senior clinical fellow and Reader in Endocrinology
University of Birmingham
