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Sponsored by: |
National Institute on Aging (NIA) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00111930 |
The purpose of the study is to examine whether DHEA replacement therapy is associated with beneficial changes in body composition (i.e., increases in lean mass and bone mass, and decreases in fat mass).
Condition | Intervention |
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Healthy |
Drug: DHEA |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Biological Effects of DHEA in the Elderly |
Estimated Enrollment: | 144 |
Study Start Date: | August 2000 |
Estimated Study Completion Date: | March 2005 |
The central hypothesis of this study is that restoring circulating levels of the adrenal hormone dehydroepiandrosterone (DHEA) in older people with low levels to more youthful levels will be associated with beneficial changes in lean mass, fat mass and bone mass.
This will be a randomized, placebo-controlled, double-blinded study. Seventy-two men and 72 women, over 60 years old, who are healthy, will be randomized to receive either a replacement dose of DHEA or placebo for 1 year. The replacement dose of DHEA will bring circulating DHEA sulfate (DHEAS) levels into the range of normal in healthy 20-30 year-old women (approximately 8 micromoles per liter [μM] or 295 micrograms per deciliter [µg/dL]) and men (approximately 10 micromoles per liter [μM] or 368 micrograms per deciliter [µg/dL]).
Fat mass and fat-free body mass will be evaluated by dual energy x-ray absorptiometry (DXA), and intra-abdominal fat volume and thigh muscle area will be measured by computed tomography (CT). Bone mineral density (BMD) of the total body, lumbar spine, and proximal femur will be measured by DXA and biochemical markers of bone resorption and formation. Glucose tolerance and insulin response will be evaluated using an oral glucose tolerance test.
If this study confirms the results of a previous preliminary study, the current study is likely to impact future scientific study regarding the role of DHEA deficiency in the biology of aging and its role as a therapeutic agent for the prevention of sarcopenia.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Prohibited Medications:
United States, Colorado | |
University of Colorado at Denver and Health Sciences Center | |
Denver, Colorado, United States, 80262 |
Principal Investigator: | Wendy M. Kohrt, PhD | University of Colorado at Denver and Health Sciences Center |
Study ID Numbers: | AG0019, AG018857 |
Study First Received: | May 26, 2005 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00111930 History of Changes |
Health Authority: | United States: Federal Government |
dehydroepiandrosterone DHEAS bone mineral density body composition |
lean mass fat mass bone mass decreased DHEAS levels |
Immunologic Factors Adjuvants, Immunologic Dehydroepiandrosterone Healthy |
Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic Dehydroepiandrosterone Pharmacologic Actions |