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NCT01160328 · ClinicalTrials.gov registry record · Phase 1
Influence of Male Hormones on Regional Fat Metabolism
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT01160328: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT01160328 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 39 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01160328, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Testosterone
- DRUG Leuprolide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2010-06 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01160328
The ClinicalTrials.gov registry entry for NCT01160328 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Testosterone is the first listed.
NCT01160328 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01160328 about?
NCT01160328 is a clinical study titled "Influence of Male Hormones on Regional Fat Metabolism". 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 av...
What is the current status of trial NCT01160328?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2010-06. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01160328?
The interventions under investigation include: Testosterone (DRUG), Leuprolide (DRUG).
Who is sponsoring clinical trial NCT01160328?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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