Influence of Male Hormones on Regional Fat Metabolism

NCT01160328 | Completed Phase 1

• 2 other identifiers: 09-000309R01DK045343
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

Regional Fat Storage; Fat Oxidation; Testosterone; Male

Outcome Measures

Primary Outcomes (1)

• Regional Fat Metabolism

  3 years

Study Arms (3)

Control Group

NO INTERVENTION

Participants in this group will not receive any treatment.

Lupron Group

EXPERIMENTAL

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

Drug: Leuprolide

Lupron & Testosterone Group

OTHER

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

Drug: Leuprolide; Drug: Testosterone

Interventions

Leuprolide DRUG

7.5 mg - 1 month depot, 2 doses over 7 weeks

Also known as: Lupron

Lupron & Testosterone Group; Lupron Group

Testosterone DRUG

7.5g - 1% testosterone gel, daily x 7 weeks

Also known as: AndroGel

Lupron & Testosterone Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Abbott: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Leuprolide; Testosterone

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Michael D Jensen, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Michael D. Jensen, M.D.

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 12, 2010
• Study Start: June 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

US (1)