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临床试验/NCT01160328
NCT01160328已完成1 期

Influence of Male Hormones on Regional Fat Metabolism

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2010年6月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
发起方
Mayo Clinic
入组人数
39
试验地点
1
主要终点
Regional Fat Metabolism

研究概览

简要总结

The male sex hormone, testosterone, plays an important role in determining body fat distribution in men. This is especially evident in the dramatic shift in body composition as boys and girls reach sexual maturity. Normal weight women have twice the body fat of a normal weight man (30% vs. 15% on average) and men will have twice the stomach fat as women (10% vs. 5% of fat as intra-abdominal, men vs. women). These are likely sex-steroid linked events. Short and long term changes in regional fat distribution accompany testosterone deficiency and can be reversed by testosterone replacement. Testosterone deficient men have increased stomach fat that can be reversed with testosterone replacement therapy. Interestingly, the mechanism by which testosterone affects where we store fat is unknown. It is important to understand how testosterone influences where we store fat as it is well established that increased stomach fat results in elevated disease risk.

The proposed study aims to examine the effect of short term, temporary testosterone decreases on how and where men store fat. The investigators will compare fat storage between men given Lupron to temporarily decrease testosterone levels those that receive Lupron plus testosterone replacement vs. a no treatment control group. Comparing these three groups will allow us to understand the effects of testosterone on short-term changes in fat tissue function that lead to the long-term changes in where we store body fat.

详细描述

There are 3 groups to which you might be assigned. Assignment to these groups is random (ie. by flip of a coin).

If you are assigned to...

  • Group 1 - you will receive no treatments.
  • Group 2 - you will be given an injection of leuprolide acetate (Lupron) which will temporarily lower sex hormones. This injection will be given two times during the 7 week treatment period.
  • Group 3 - you will be given the injections of Lupron but after the second injection, you will also be required to apply a testosterone gel that will result in maintenance of your testosterone levels. The testosterone gel is rubbed on the upper shoulders, similar to putting on suntan lotion. You will be shown how to put this on.

If you are in group 2 or 3 you will be given testosterone gel, a male hormone, at the end of the study to help prevent symptoms such as hot flashes, until your body has time to return to its pre-study hormone levels. This can take up to 4 weeks.

In addition to the treatment period, you will also:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy, weight stable individuals
  • BMI 20-29 kg/m2

排除标准

  • Smoking and tobacco use
  • Diabetes and other disease
  • Anti-depressants

研究组 & 干预措施

Lupron Group

Experimental

Participants in this group will receive leuprolide acetate (Lupron) treatment for 7 weeks resulting in temporary decreases in testosterone levels.

干预措施: Leuprolide (Drug)

Lupron & Testosterone Group

Other

Participants in this group will receive 7 weeks of leuprolide acetate (Lupron) treatment with testosterone gel (Androgel).

干预措施: Leuprolide (Drug)

Lupron & Testosterone Group

Other

Participants in this group will receive 7 weeks of leuprolide acetate (Lupron) treatment with testosterone gel (Androgel).

干预措施: Testosterone (Drug)

结局指标

主要结局

Regional Fat Metabolism

时间窗: 3 years

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael D. Jensen

Michael D. Jensen, M.D.

Mayo Clinic

研究点 (1)

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