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Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00099697
First Posted: December 20, 2004
Last Update Posted: December 11, 2009
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.
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)
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
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: 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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years to 78 Years   (Adult, Senior)
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
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
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00099697     History of Changes
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 Submitted: December 17, 2004
First Posted: December 20, 2004
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:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs