Biological Effects of Dehydroepiandrosterone (DHEA) in the Elderly
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|ClinicalTrials.gov Identifier: NCT00111930|
Recruitment Status : Completed
First Posted : May 27, 2005
Last Update Posted : December 11, 2009
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: DHEA||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Biological Effects of DHEA in the Elderly|
|Study Start Date :||August 2000|
|Actual Primary Completion Date :||March 2005|
|Actual Study Completion Date :||March 2005|
- bone mineral density
- body composition
- blood lipids/lipoproteins
- glucose tolerance
- arterial compliance
- visceral adiposity
- quality of life
- sex steroids and growth factors
- sexual health
- cognitive function
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111930
|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, Denver|