Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans

Not Applicable

Completed

• Conditions: Aging; Obesity; Insulin Resistance

• Registration Number: NCT00099697
• Lead Sponsor: National Institute on Aging (NIA)

Brief Summary

The purpose of this study is to determine whether DHEA replacement therapy decreases abdominal fat and improves insulin sensitivity.

Detailed Description

Studies on rats and mice have shown that the adrenal hormone dehydroepiandrosterone (DHEA) reduces abdominal visceral fat and protects against insulin resistance. This study was done to learn if DHEA replacement therapy decreases abdominal obesity and improves insulin action in humans.

Participants were randomly assigned to receive 50 mg per day of DHEA or a placebo at bedtime for 6 months. Participants underwent magnetic resonance imaging (MRI) and oral glucose tolerance tests at the beginning and conclusion of the study. Other tests included measurements of hormones and lipids.

Study Timeline

• Study Start: 2001-06
• Primary Completion: 2004-02
• Study Completion: 2004-02
• Status Verified: 2004-12
• Study First Submitted: 2004-12-17
• Study First Submitted QC: 2004-12-17
• Study First Posted: 2004-12-20
• Last Update Submitted: 2009-12-09
• Last Update Posted: 2009-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• 65 to 78 years old
• Physically healthy
• Non-smoker
• On stable medications for at least 6 months
• Stable body weight for the past year

Exclusion Criteria

• Serious active medical problems
• Hormone therapy
• Abnormal PSA (prostate specific antigen) in men

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
6-month change in visceral and subcutaneous abdominal fat

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States