Influence of Male Hormones on Regional Fat Metabolism

This study has been completed.
Sponsor:
Collaborators:
Abbott
Information provided by (Responsible Party):
Michael D. Jensen, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01160328
First received: July 8, 2010
Last updated: May 13, 2014
Last verified: May 2014

July 8, 2010
May 13, 2014
June 2010
January 2013   (final data collection date for primary outcome measure)
Regional Fat Metabolism [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01160328 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Influence of Male Hormones on Regional Fat Metabolism
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 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…

  • 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:

  • If you are in group 1, have 4 fat biopsies that are like a miniature liposuction. The investigators numb the skin before doing the biopsies. If you are in group 2 or 3, you will also have 1 muscle biopsy at the end of the treatment period. In addition, if you are in group 2 or 3, you will also have a fat and muscle biopsy before you start the hormone treatment.
  • All groups will need to spend two days and nights in the Clinical Research Unit of the Mayo Clinic and your meals will be provided by the for 5 days beforehand. You will also need to spend one morning undergoing some initial tests.
  • You will have your body fat measured before and after the hormone treatment using x-ray like equipment that will expose you to some radiation.
  • Our measures of fat metabolism use molecules that have a small amount of radioactivity.

Remuneration is provided.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Obesity
  • Drug: Leuprolide
    7.5 mg - 1 month depot, 2 doses over 7 weeks
    Other Name: Lupron
  • Drug: Testosterone
    7.5g - 1% testosterone gel, daily x 7 weeks
    Other Name: AndroGel
  • No Intervention: Control Group
    Participants in this group will not receive any treatment.
  • Experimental: Lupron Group
    Participants in this group will receive leuprolide acetate (Lupron) treatment for 7 weeks resulting in temporary decreases in testosterone levels.
    Intervention: Drug: Leuprolide
  • Lupron & Testosterone Group
    Participants in this group will receive 7 weeks of leuprolide acetate (Lupron) treatment with testosterone gel (Androgel).
    Interventions:
    • Drug: Leuprolide
    • Drug: Testosterone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Smoking and tobacco use
  • Diabetes and other disease
  • Anti-depressants
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01160328
09-000309, R01DK045343
No
Michael D. Jensen, Mayo Clinic
Mayo Clinic
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Abbott
Principal Investigator: Michael D Jensen, M.D. Mayo Clinic
Mayo Clinic
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP