Aging Clinical Trial
Official title:
Pathogenesis of Sarcopenia and Metabolic Changes in Aging
Sarcopenia is a major health problem among the rapidly expanding elderly population in our
society. Disabilities directly related to muscle weakness, and indirectly related to changes
in body composition and metabolic dysfunctions, are causing a staggering toll in disability
and health care costs.
Osteopenia occurs almost simultaneously with sarcopenia in the elderly population and muscle
weakness increases the risk for falls and therefore, fractures. Although these issues have
been separate addressed in several studies, an integrated investigational approach to better
understand the pathogenesis of sarcopenia and other age-related metabolic abnormalities and
to investigate the potential role of androgens have not been undertaken in a comprehensive
manner.
The program contains four independent research programs, each representing different
research disciplines, and four separate cores supporting the four projects.
The main focus of the project is to determine the effect of the replacement of testosterone
in elderly men and DHEA in elderly men and women and to compare these effects with placebo
treatment over a two-year period.
Project 1, "Effect of Androgen Replacement on Muscle Metabolism" will specifically determine
whether these interventions have a differential effect on size and quality of muscle in
terms of strength and metabolic functions. Project 2, "Effect of Androgen Replacement on
Bone Metabolism," will determine the effects of this intervention on bone mineral density
and markers of bone turnover.
Project 3, "The Effect of Androgen Replacement on Carbohydrate Metabolism," will determine
whether the age-associated decrease in circulating androgens contributes to the alterations
in carbohydrate metabolism that are commonly observed in the elderly and on insulin action,
insulin secretion, and glucose effectiveness.
Project 4, "Effect of Androgen Replacement on Fat Metabolism" will determine whether changes
in fat distribution that occur with aging could result from differences in regional fatty
acid uptake and systemic fatty acid kinetics, and whether these determinants of fat
distribution are altered by the interventions.
The data emerging from these studies will be integrated to determine the intervention of
sarcopenia with other metabolic changes and hopefully will contribute to a better
understanding of muscle, bone, carbohydrate and fat metabolism.
This study will hopefully form the scientific basis for future trials of androgen
replacement in the elderly.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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