Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans

• ClinicalTrials.gov Identifier: NCT00099697
• Recruitment Status: Completed
• First Posted: December 20, 2004
• Last Update Posted: December 11, 2009
• Sponsor: National Institute on Aging (NIA)
• 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)

Tracking Information

• First Submitted Date: December 17, 2004
• First Posted Date: December 20, 2004
• Last Update Posted Date: December 11, 2009
• Study Start Date: June 2001
• Actual Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 23, 2005): 6-month change in visceral and subcutaneous abdominal fat
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00099697 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Masking: Double; Primary Purpose: Prevention

Condition

• Aging
• Obesity
• Insulin Resistance

• Intervention: Drug: DHEA
• Study Arms: Not Provided

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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: June 23, 2005): 56
• Original Enrollment: Same as current
• Actual Study Completion Date: February 2004
• Actual Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years to 78 Years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00099697
• 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 )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• 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

• PRS Account: National Institute on Aging (NIA)
• Verification Date: December 2004