Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111930
Status:
COMPLETED
Last Update Posted:
2009-12-11
First Post:
2005-05-26
Brief Title:
Biological Effects of Dehydroepiandrosterone DHEA in the Elderly
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Biological Effects of DHEA in the Elderly
Status:
COMPLETED
Status Verified Date:
2009-02
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:
The purpose of the study is to examine whether DHEA replacement therapy is associated with beneficial changes in body composition ie increases in lean mass and bone mass and decreases in fat mass
Detailed Description:
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 µgdL and men approximately 10 micromoles per liter μM or 368 micrograms per deciliter µgdL
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
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 µgdL and men approximately 10 micromoles per liter μM or 368 micrograms per deciliter µgdL
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AG018857 | None | None | None |