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Sponsored by: |
Washington University School of Medicine |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00205686 |
DHEA or dehydroepiandrosterone is a naturally occurring hormone secreted by tghe adrenal galnds. The secretion of HDEA declines with aging. DHEA is considered a food supplement and it is not regulated by the FDA. The purpose of this research is to evaluate ceratin of the biological effects of a reaplcement dose of DHEA. As you get older, DHEA levels are lower than you were younger. The replamcent dose is the dose of DHEA that will raise DHEA levesl to the levels found in young people. Anotehr purpose is to determine whether DHEA enhances the adaptations to an exercise training program.
Condition | Intervention | Phase |
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Healthy Volunteers |
Drug: DHEA Behavioral: exercise |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | DHEA+Exercise-Effect on Sarcopenia and Osteopenia of Aging |
Estimated Enrollment: | 64 |
Study Start Date: | April 2001 |
Estimated Study Completion Date: | September 2005 |
DHEA declines dramatically with age. Low DHEA levels have been found to correlate with sarcopenia and osteopenia. It is, therefore, postulated that many physiologic changes of aging are secondary to the decline in DHEA. Thus, the objective of the proposed research is to evaluate the effect of DHEA replacement on age-related changes in body composition, muscle function and metabolism, and bone mass in healthy older adults. The specific aims are to evaluate the effects of DHEA replacement (50 mg/d) alone, or in combination with resistance exercise training on: a) lean body mass, intraabdominal fat and thigh muscle volume, and muscle protein synthesis rate b) bone mineral density (BMD) of the total body, lumbar spine, and hip and biochemical markers of bone turnover and c) insulin sensitivity. It is hypothesized that DHEA administration will have additive or synergistic effects with exercise. Healthy but sedentary subjects , aged 65-78 years old, will be randomized to receive either DHEA, 50 mg/d, or placebo and to participate in either supervised or home exercise training programs. The supervised exercise program will consist of resistance training designed to increase muscle mass, strength, and bone mass, and decrease fat mass. The goal of this research is to provide information on the potential role of DHEA replacement therapy in maintaining the physical health and functional capacity of older people
Ages Eligible for Study: | 65 Years to 78 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | Dennis T Villareal, MD | Washington University School of Medicine |
Study ID Numbers: | K23RR016191, K23RR016191 |
Study First Received: | September 13, 2005 |
Last Updated: | January 4, 2006 |
ClinicalTrials.gov Identifier: | NCT00205686 |
Health Authority: | United States: Institutional Review Board |
Aging, dhea, bone density, muscle mass, insulin action |
Dehydroepiandrosterone Healthy Insulin |
Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions |