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Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans

Primary Purpose

Aging, Obesity, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DHEA
Sponsored by
National Institute on Aging (NIA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aging focused on measuring abdominal fat, dehydroepiandrosterone, Insulin sensitivity

Eligibility Criteria

65 Years - 78 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Washington University School of Medicine

Outcomes

Primary Outcome Measures

6-month change in visceral and subcutaneous abdominal fat

Secondary Outcome Measures

Full Information

First Posted
December 17, 2004
Last Updated
December 9, 2009
Sponsor
National Institute on Aging (NIA)
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT00099697
Brief Title
Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans
Official Title
Biologic Effects of DHEA in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
December 2004
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
February 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Aging (NIA)
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Research Resources (NCRR)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Obesity, Insulin Resistance
Keywords
abdominal fat, dehydroepiandrosterone, Insulin sensitivity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Masking
Double
Allocation
Randomized
Enrollment
56 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
DHEA
Primary Outcome Measure Information:
Title
6-month change in visceral and subcutaneous abdominal fat

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John O. Holloszy, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dennis T. Villareal, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9374813
Citation
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.
Results Reference
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PubMed Identifier
9467418
Citation
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. doi: 10.1093/gerona/53a.1.b19.
Results Reference
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PubMed Identifier
11106916
Citation
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. doi: 10.1046/j.1365-2265.2000.01131.x.
Results Reference
background
PubMed Identifier
15536111
Citation
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. doi: 10.1001/jama.292.18.2243.
Results Reference
result

Learn more about this trial

Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans

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