Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182975
Status:
COMPLETED
Last Update Posted:
2008-08-25
First Post:
2005-09-13
Brief Title:
Effects of Dehydroepiandrosterone DHEA in Humans
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Is DHEA Replacement Beneficial
Status:
COMPLETED
Status Verified Date:
2008-08
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 this study is to determine whether bringing back the DHEA levels of older persons to the young range produces beneficial effects
Detailed Description:
DHEA and DHEA sulfate DHEAS plasma concentrations peak at about 20 years of age and decline rapidly and markedly after age 25 yr DHEA is a PPAR-alpha activator PPAR-alpha plays major roles in regulating lipid metabolism and controlling inflammation DHEA also appears to have anabolic effects on muscle and bone The study is designed to determine the effects of 12 months of DHEA replacement in 65-75 year old women and men on a truncal and visceral fat b insulin resistance and serum triglycerides c muscle mass and strength d bone mineral density e chronic inflammation f arterial-endothelium-dependent vasodilation and g sense of well being
The specific aims of this study are to test the hypotheses that 12 months of DHEA replacement will a Result in significant decreases in truncal and visceral fat by shifting metabolism to fat oxidation and increasing energy wastage b Decrease insulin resistance and decrease serum triglycerides c Increase muscle mass and strength by decreasing catabolic stimuli and increasing anabolic stimuli d Increase bone mineral density by increasing anabolic stimuli and decreasing catabolic stimuli e Reduce chronic inflammation and decrease pro-inflammatory cytokine production by peripheral blood mononuclear cells f Improve arterial endothelium dependent vasodilation and g Improve general sense of well being
The specific aims of this study are to test the hypotheses that 12 months of DHEA replacement will a Result in significant decreases in truncal and visceral fat by shifting metabolism to fat oxidation and increasing energy wastage b Decrease insulin resistance and decrease serum triglycerides c Increase muscle mass and strength by decreasing catabolic stimuli and increasing anabolic stimuli d Increase bone mineral density by increasing anabolic stimuli and decreasing catabolic stimuli e Reduce chronic inflammation and decrease pro-inflammatory cytokine production by peripheral blood mononuclear cells f Improve arterial endothelium dependent vasodilation and g Improve general sense of well being
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 |
|---|---|---|---|
| R01AG020076 | NIH | None | httpsreporternihgovquickSearchR01AG020076 |