Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans
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ClinicalTrials.gov Identifier: NCT00099697 |
Recruitment Status :
Completed
First Posted : December 20, 2004
Last Update Posted : December 11, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Aging Obesity Insulin Resistance | Drug: DHEA | Not Applicable |
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 (Clinical Trial) |
Enrollment : | 56 participants |
Allocation: | Randomized |
Masking: | Double |
Primary Purpose: | Prevention |
Official Title: | Biologic Effects of DHEA in Humans |
Study Start Date : | June 2001 |
Actual Primary Completion Date : | February 2004 |
Actual Study Completion Date : | February 2004 |
- 6-month change in visceral and subcutaneous abdominal fat

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Ages Eligible for Study: | 65 Years to 78 Years (Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00099697
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | John O. Holloszy, MD | Washington University School of Medicine | |
Principal Investigator: | Dennis T. Villareal, MD | Washington University School of Medicine |
Other Publications:
ClinicalTrials.gov Identifier: | NCT00099697 |
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 ) |
First Posted: | December 20, 2004 Key Record Dates |
Last Update Posted: | December 11, 2009 |
Last Verified: | December 2004 |
abdominal fat dehydroepiandrosterone Insulin sensitivity |
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |