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Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00099697
Recruitment Status : Completed
First Posted : December 20, 2004
Last Update Posted : December 11, 2009
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Information provided by:
National Institute on Aging (NIA)

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

Condition or disease Intervention/treatment Phase
Aging Obesity Insulin Resistance Drug: DHEA Not Applicable

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 Design
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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
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 6-month change in visceral and subcutaneous abdominal fat

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 78 Years   (Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


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

Other Publications:

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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
Keywords provided by National Institute on Aging (NIA):
abdominal fat
dehydroepiandrosterone
Insulin sensitivity
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases