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临床试验/NCT01923090
NCT01923090Unknown2 期

An Open Label Study of 5α-reductase Inhibition on the Regulation of Insulin Action and Metabolic Phenotype in Healthy Volunteers.

University of Birmingham1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2012年8月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Finasteride treatment 5mg for 3 weeks

干预措施: Finasteride (Drug)

Dutasteride

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Jeremy Tomlinson

MRC Senior clinical fellow and Reader in Endocrinology

University of Birmingham

研究点 (1)

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