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Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans

This study has been completed.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Information provided by:
National Institute on Aging (NIA) Identifier:
First received: December 17, 2004
Last updated: December 9, 2009
Last verified: December 2004
The purpose of this study is to determine whether DHEA replacement therapy decreases abdominal fat and improves insulin sensitivity.

Condition Intervention
Insulin Resistance
Drug: DHEA

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Biologic Effects of DHEA in Humans

Resource links provided by NLM:

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: 56
Study Start Date: June 2001
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   65 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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 identifier: NCT00099697

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

Publications: Identifier: NCT00099697     History of Changes
Other Study ID Numbers: AG0013  5P60AG013629  5R01AG020076  5K23RR016191  3P30DK056341  5P60DK020579  2M01RR000036 
Study First Received: December 17, 2004
Last Updated: December 9, 2009

Keywords provided by National Institute on Aging (NIA):
abdominal fat
Insulin sensitivity

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs processed this record on February 17, 2017