Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00470002
Status:
COMPLETED
Last Update Posted:
2007-05-07
First Post:
2007-05-04
Brief Title:
Effects of Growth Hormone on the Nitric Oxide Pathway
Sponsor:
Hannover Medical School
Organization:
Hannover Medical School
Study Overview
Official Title:
Effects of Growth Hormone GH on Parameters of the Nitric Oxide NO Pathway
Status:
COMPLETED
Status Verified Date:
2007-05
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:
The purpose of the study is to determine whether the treatment with growth hormone has an influence on the nitric oxide pathway in healthy males
Detailed Description:
Nitric oxide NO is a potent endogenous vasodilator and has shown to inhibit key processes of atherosclerosis like monocyte adhesion platelet aggregation and vascular smooth muscle cell proliferation Impaired endothelial NO production is a main feature of endothelial dysfunction which by itself is an early step in the course of atherosclerotic vascular disease
Recent studies could confirm this close association between parameters of the NO pathway and cardiovascular disease and could further enhance the knowledge on the pathophysiological mechanisms There is a significant relationship between insulin resistance and the endogenous NO synthase inhibitor asymmetric dimethylarginine ADMA Moreover evidence could be provided that plasma levels of ADMA are a strong and independent predictor of mortality and cardiovascular outcome in haemodialysis patients
Patients with growth hormone deficiency are characterized by a 19 fold higher risk of death from cardiovascular disease Again there is good evidence that alterations of the NO-pathway are involved in this increase of cardiovascular risk A reduced endogenous systemic production of NO was found in patients with growth hormone deficiency treatment with recombinant growth hormone normalized NO production The effects of growth hormone on NO are possibly mediated by insulin-like growth factor-I IGF-I which stimulates NO synthesis in vitro The onset of IGF-I increase in healthy volunteers treated with GH is evident after 12 h the maximum effect takes place between 5 to 8 days Also in adults with growth hormone deficiency the major effects of growth hormone treatment on IGF-I levels are observed within 2 weeks After discontinuation of growth hormone therapy IGF-1 levels return to base line within 2-3 days
The aim of the present study is to further elucidate the in vivo effects of GH on the NO pathway and NO mediated cardiovascular functions
Recent studies could confirm this close association between parameters of the NO pathway and cardiovascular disease and could further enhance the knowledge on the pathophysiological mechanisms There is a significant relationship between insulin resistance and the endogenous NO synthase inhibitor asymmetric dimethylarginine ADMA Moreover evidence could be provided that plasma levels of ADMA are a strong and independent predictor of mortality and cardiovascular outcome in haemodialysis patients
Patients with growth hormone deficiency are characterized by a 19 fold higher risk of death from cardiovascular disease Again there is good evidence that alterations of the NO-pathway are involved in this increase of cardiovascular risk A reduced endogenous systemic production of NO was found in patients with growth hormone deficiency treatment with recombinant growth hormone normalized NO production The effects of growth hormone on NO are possibly mediated by insulin-like growth factor-I IGF-I which stimulates NO synthesis in vitro The onset of IGF-I increase in healthy volunteers treated with GH is evident after 12 h the maximum effect takes place between 5 to 8 days Also in adults with growth hormone deficiency the major effects of growth hormone treatment on IGF-I levels are observed within 2 weeks After discontinuation of growth hormone therapy IGF-1 levels return to base line within 2-3 days
The aim of the present study is to further elucidate the in vivo effects of GH on the NO pathway and NO mediated cardiovascular functions
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 |
|---|---|---|---|
| VP2-3900-4021576 | None | None | None |
| IRB3444 | None | None | None |