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临床试验/NCT00613288
NCT00613288已完成不适用

Testosterone and Lipolysis, Insulin Sensitivity and Protein Metabolism

University of Aarhus1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2007年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Testosterone influence on Insulin Sensitivity, Lipolysis and protein metabolism

研究概览

简要总结

Testosterone(T) has known effects on many organ systems, although many of its metabolic actions are unrevealed. T is an anabolic hormone stimulating protein synthesis but this effect has barely been investigated in controlled studies. It also has lipolytic actions influencing body composition, but little is known of its regional impact on fat tissue. T affects insulin sensitivity. There is an increased incidence of hypogonadism in type 2 diabetes, and among patients with hypogonadism there is an increased incidence of type 2 diabetes. The actions of testosterone on glucose metabolism are unknown.

The purpose of this study is therefore to:

Investigate the lipolytic effect of testosterone on muscle and fat tissue. To gain insight in the intracellular mechanisms of testosterone on lipolysis and investigate possible regional differences in lipolysis and changes in body composition.

Finally to investigate the effect of short term experimental hypogonadism and acute testosterone substitution on cytokines, insulin sensitivity and protein metabolism.

The trial is a randomised double blinded cross-over study of 4 x 2 days with an interval of 1 month in between. 12 healthy young men will receive GnRH treatment over a 3 month period and examined on 4 occasions with various degrees of T substitution and placebo . The examinations take place at the Research Lab within the Medical Department M.

The investigations are deemed relevant to the understanding of the interrelationship between male hypogonadism and type 2 diabetes. The hypothesis is that T has beneficial effects on carbohydrate, fat and protein metabolism. The generated knowledge would therefore hopefully improve prophylaxis, screening and early treatment of both group of patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Male, age 20-35
  • Normal biochemical screen and ECG

排除标准

  • Heart disease
  • Antecedent or present cancer
  • Vascular disease
  • Antecedent or present hormone treatment
  • Medical treatment with known effects on fat metabolism
  • Big X-ray examinations equivalent to, or more than a chest x-ray and all kinds of CT scans until 6 month before the start of the study and during the study.

研究组 & 干预措施

A

Experimental

干预措施: Testosterone (Testogel), GnRH analog (Leuprorelide) and Placebo (Drug)

结局指标

主要结局

Testosterone influence on Insulin Sensitivity, Lipolysis and protein metabolism

时间窗: 4-6 month pr patient

次要结局

  • Testosterone influence on Body composition by DEXA scan, Energy expenditure by indirect Calorimetry and VO2 max test(4-6 month pr patient)

研究者

申办方类型
Other

研究点 (1)

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