Ignite Creation Date:
2024-05-05 @ 11:47 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01410799
Status:
TERMINATED
Last Update Posted:
2019-05-24
First Post:
2011-06-17
Brief Title:
Three Month Treatment of Growth Hormone Releasing Hormone GHRH in the Elderly
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Three Month Treatment of GHRH Growth Hormone Releasing Hormone in the Elderly
Status:
TERMINATED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding ended
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 evaluate the effect of a naturally occurring hormone called Growth Hormone Releasing Hormone GHRH on the muscle bone and fat tissues of the body GHRH stimulates the production of growth hormone GH which regulates the build up of many tissues in the body including muscles and bones Many elderly people have low levels of GH The overall goal of this research is to determine the efficacy of GHRH to raise levels of GH and improve these body tissues Healthy men and women age 65 and older will receive GHRH in four doses nightly for 12 weeks and assessed for changes in muscle strength body mass physical performance and how the body uses sugar
Detailed Description:
Although multiple factors appear to be associated with the functional deterioration of advanced age decreases in muscle mass and strength sarcopenia are commonly seen in aging subjects and are major risk factors for subsequent disability There are many potential causes of sarcopenia and functional impairment in the elderly including medical conditions such as cardiovascular disease altered mood and sedentary lifestyle Hyposomatotropism or decreased activity of growth hormone GH is one factor that has been implicated
GH is a major anabolic hormone that exerts important stimulatory effects on protein synthesis Many of the peripheral tissue effects of GH are mediated by insulin-like growth factor 1 IGF-1 produced systemically by the liver or locally in tissues in response to GH stimulation IGF-1 in turn regulates GH secretion by negative feedback mechanisms at the pituitary gland Several investigators have shown that aging is associated with a decrease in spontaneous GH secretion and IGF-1 levels GH levels decline by 14 for each decade after puberty Reduction of GH release in aging is thought to be associated with an increase in somatostatin tone decrease in hypothalmic GHRH output and diminished response to GHRH The fact that aging is accompanied by a decrease in protein synthesis leading to a loss of lean body mass and a gain in body fat suggests that a decrease in GH secretion may contribute to these changes It has been hypothesized that restoration of GH level in the elderly to the levels observed in younger individuals may lead to improvements in body composition GH may also increase slow wave delta or deep sleep in older adults
GH is a major anabolic hormone that exerts important stimulatory effects on protein synthesis Many of the peripheral tissue effects of GH are mediated by insulin-like growth factor 1 IGF-1 produced systemically by the liver or locally in tissues in response to GH stimulation IGF-1 in turn regulates GH secretion by negative feedback mechanisms at the pituitary gland Several investigators have shown that aging is associated with a decrease in spontaneous GH secretion and IGF-1 levels GH levels decline by 14 for each decade after puberty Reduction of GH release in aging is thought to be associated with an increase in somatostatin tone decrease in hypothalmic GHRH output and diminished response to GHRH The fact that aging is accompanied by a decrease in protein synthesis leading to a loss of lean body mass and a gain in body fat suggests that a decrease in GH secretion may contribute to these changes It has been hypothesized that restoration of GH level in the elderly to the levels observed in younger individuals may lead to improvements in body composition GH may also increase slow wave delta or deep sleep in older adults
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 |
|---|---|---|---|
| P01AG000599 | NIH | None | httpsreporternihgovquickSearchP01AG000599 |