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Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans

Biologic Effects of DHEA in Humans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00099697
Enrollment
56
Registered
2004-12-20
Start date
2001-06-30
Completion date
2004-02-29
Last updated
2009-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Insulin Resistance, Obesity

Keywords

abdominal fat, dehydroepiandrosterone, Insulin sensitivity

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.

Interventions

DRUGDHEA

Sponsors

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

Study design

Allocation
RANDOMIZED
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
65 Years to 78 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
6-month change in visceral and subcutaneous abdominal fat

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026