Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans

This study has been completed.

Sponsors and Collaborators:	National Institute on Aging (NIA) 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

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

MedlinePlus related topics: Obesity

Drug Information available for: Insulin Dehydroepiandrosterone sulfate Prasterone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control
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
Estimated Study Completion Date:	February 2004

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 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 Pt 2):R1704-8.

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.

Study ID Numbers:	AG0013, 5P60AG013629, 5R01AG020076, 5K23RR016191, 3P30DK056341, 5P60DK020579, 2M01RR000036
Study First Received:	December 17, 2004
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00099697
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

abdominal fat
dehydroepiandrosterone
Insulin sensitivity

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Dehydroepiandrosterone
Overweight
Insulin
Body Weight
Hyperinsulinism

Signs and Symptoms
Nutrition Disorders
Overnutrition
Insulin Resistance
Glucose Metabolism Disorders
Metabolic disorder

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009