Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans

Official Title ^†

Biologic Effects of DHEA in Humans

Brief Summary

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

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 Phase

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double-Blind, Placebo Control

Primary Outcome Measure ^†

6-month change in visceral and subcutaneous abdominal fat

Secondary Outcome Measure ^†

Condition ^†

Aging
Obesity
Insulin Resistance

Intervention ^†

Drug: DHEA

MEDLINE PMIDs

15536111, 9374813, 9467418, 11106916

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

June 2001

Completion Date

February 2004

Eligibility 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

Gender

Both

Ages

65 Years to 78 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00099697

Organization ID

AG0013

Secondary IDs ^††

5P60AG013629, 5R01AG020076, 5K23RR016191, 3P30DK056341, 5P60DK020579, 2M01RR000036

Study Sponsor ^†

National Institute on Aging (NIA)

Collaborators ^††

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

Information Provided By

National Institute on Aging (NIA)

Verification Date

December 2004

First Received Date ^†

December 17, 2004

Last Updated Date

June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.