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
  Purpose

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.


Condition Intervention Phase
Obesity
Drug: Leuprolide
Drug: Testosterone
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Influence of Male Hormones on Regional Fat Metabolism

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Regional Fat Metabolism [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: June 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Leuprolide
7.5 mg - 1 month depot, 2 doses over 7 weeks
Other Name: Lupron
Lupron & Testosterone Group
Participants in this group will receive 7 weeks of leuprolide acetate (Lupron) treatment with testosterone gel (Androgel).
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Smoking and tobacco use
  • Diabetes and other disease
  • Anti-depressants
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160328

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Abbott
Investigators
Principal Investigator: Michael D Jensen, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Michael D. Jensen, Michael D. Jensen, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01160328     History of Changes
Other Study ID Numbers: 09-000309, R01DK045343
Study First Received: July 8, 2010
Last Updated: May 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Regional Fat Storage
Fat Oxidation
Testosterone
Male

Additional relevant MeSH terms:
Leuprolide
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Fertility Agents
Fertility Agents, Female
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014