Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans

Obesity Clinical Trial

Official title:

Biologic Effects of DHEA in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099697
• Other study ID #: AG0013
• Secondary ID: 5P60AG0136295R01
• Status: Completed
• Phase: N/A
• First received: December 17, 2004
• Last updated: December 9, 2009
• Start date: June 2001
• Est. completion date: February 2004

Study information

• Verified date: December 2004
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 78 Years

Eligibility

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

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aging
• Insulin Resistance
• Obesity

Intervention

Drug:
• DHEA

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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 Pt 2):R1704-8. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-month change in visceral and subcutaneous abdominal fat