Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans

December 9, 2009 updated by: National Institute on Aging (NIA)

Biologic Effects of DHEA in Humans

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 78 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
6-month change in visceral and subcutaneous abdominal fat

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Aging (NIA)

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (Actual)

February 1, 2004

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

December 17, 2004

First Submitted That Met QC Criteria

December 17, 2004

First Posted (Estimate)

December 20, 2004

Study Record Updates

Last Update Posted (Estimate)

December 11, 2009

Last Update Submitted That Met QC Criteria

December 9, 2009

Last Verified

December 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG0013
  • 5P60AG013629 (U.S. NIH Grant/Contract)
  • 5R01AG020076 (U.S. NIH Grant/Contract)
  • 5K23RR016191 (U.S. NIH Grant/Contract)
  • 3P30DK056341 (U.S. NIH Grant/Contract)
  • 5P60DK020579 (U.S. NIH Grant/Contract)
  • 2M01RR000036 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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