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Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans

This study has been completed.
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)
ClinicalTrials.gov Identifier:
NCT00099697
First received: December 17, 2004
Last updated: December 9, 2009
Last verified: December 2004
History of Changes
  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-Blind
Primary Purpose: Prevention
Official Title: Biologic Effects of DHEA in Humans

Resource links provided by NLM:

Drug Information available for: Prasterone
U.S. FDA Resources

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

Ages Eligible for Study:   65 Years to 78 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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, 5R01AG020076, 5K23RR016191, 3P30DK056341, 5P60DK020579, 2M01RR000036
Study First Received: December 17, 2004
Last Updated: December 9, 2009
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Signs and Symptoms
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013