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

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

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

Outcome Measures

Primary Outcome Measures :

6-month change in visceral and subcutaneous abdominal fat

Eligibility Criteria

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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

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

Publications of Results:

Villareal DT, Holloszy JO. Effect of DHEA on abdominal fat and insulin action in elderly women and men: a randomized controlled trial. JAMA. 2004 Nov 10;292(18):2243-8.

Other Publications:

Hansen PA, Han DH, Nolte LA, Chen M, Holloszy JO. DHEA protects against visceral obesity and muscle insulin resistance in rats fed a high-fat diet. Am J Physiol. 1997 Nov;273(5):R1704-8. doi: 10.1152/ajpregu.1997.273.5.R1704.

Han DH, Hansen PA, Chen MM, Holloszy JO. DHEA treatment reduces fat accumulation and protects against insulin resistance in male rats. J Gerontol A Biol Sci Med Sci. 1998 Jan;53(1):B19-24.

Villareal DT, Holloszy JO, Kohrt WM. Effects of DHEA replacement on bone mineral density and body composition in elderly women and men. Clin Endocrinol (Oxf). 2000 Nov;53(5):561-8.

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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 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	Dehydroepiandrosterone Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs

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