Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans

This study has been completed.

Sponsors and Collaborators:	National Institute on Aging (NIA) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Center for Research Resources (NCRR)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00099697

Purpose

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

Condition	Intervention
Aging Obesity Insulin Resistance	Drug: DHEA

MedlinePlus related topics: Obesity

Drug Information available for: Insulin Dehydroepiandrosterone sulfate Prasterone

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Prevention, Randomized, Double-Blind, Placebo Control

Official Title:

Biologic Effects of DHEA in Humans

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

6-month change in visceral and subcutaneous abdominal fat

Estimated Enrollment:

Study Start Date:

June 2001

Estimated Study Completion Date:

February 2004

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.

Eligibility

Ages Eligible for Study:

65 Years to 78 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099697

Locations

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

National Institute on Aging (NIA)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Center for Research Resources (NCRR)

Investigators

Principal Investigator:	John O. Holloszy, MD	Washington University School of Medicine
Principal Investigator:	Dennis T. Villareal, MD	Washington University School of Medicine