A Phase 1 interventional study of Leuprolide and Testosterone in Obesity, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-14.
Sponsored by Mayo Clinic · Phase 1, Interventional, and Basic science
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.
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…
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:
Remuneration is provided.
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 39 is below the median of 77 across 5,084 interventional studies indexed under Obesity.
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Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.
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Exclusion Criteria:
Participants in this group will not receive any treatment.
Participants in this group will receive leuprolide acetate (Lupron) treatment for 7 weeks resulting in temporary decreases in testosterone levels.
Drug: Leuprolide
Participants in this group will receive 7 weeks of leuprolide acetate (Lupron) treatment with testosterone gel (Androgel).
Drug: Leuprolide · Drug: Testosterone
7.5 mg - 1 month depot, 2 doses over 7 weeks
Also known as: Lupron
7.5g - 1% testosterone gel, daily x 7 weeks
Also known as: AndroGel
Regional Fat Metabolism
Time frame: 3 years
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Leuprolide