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DHEA and Testosterone Replacement in Elderly

Pathogenesis of Sarcopenia and Metabolic Changes in Aging

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00254371
Enrollment
150
Registered
2005-11-16
Start date
1998-07-31
Completion date
2007-02-28
Last updated
2011-05-23

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

Conditions

Aging, Low DHEA for Women, Low Testosterone and DHEA for Men

Brief summary

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.

Interventions

PROCEDUREAndrogen Replacement

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
National Institutes of Health (NIH)
CollaboratorNIH
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

bioavailable testosterone less than 103 nanogram/dl and DHEA-S level less than 157 microgram/dl for men; DHEA-S less than 95 microgram/dl for women;

Exclusion criteria

significant ischemic heart disease, renal disease, uncontrolled hypertension, diabetes mellitus, malignancy, malabsorption, bone disorders, chronic obstructive pulmonary disease, or sleep apnea. Others

Design outcomes

Primary

MeasureTime frame
physical performance (VO2 peak, muscle strength as measured by chest press, double knee extension, and isokinetic knee extension
body composition (fat percent, fat free mass, abdominal visceral fat, and thigh muscle area)
bone parameters (BMD of ultradistal radius, femur neck, femur total and anterior-posterior of L2-L4 spine
fasting plasma insulin and glucose

Secondary

MeasureTime frame
quality of life
prostate size
glucose and insulin after mixed meal
muscle protein synthesis
hormone levels

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026