Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00254371
Status:
COMPLETED
Last Update Posted:
2011-05-23
First Post:
2005-11-14
Brief Title:
DHEA and Testosterone Replacement in Elderly
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Pathogenesis of Sarcopenia and Metabolic Changes in Aging
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P01AG014383 | NIH | None | httpsreporternihgovquickSearchP01AG014383 |