Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408577
Status:
COMPLETED
Last Update Posted:
2006-12-12
First Post:
2006-12-06
Brief Title:
Prevention of Cardiac and Vascular Events in Patients With NGTIGT
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Prevention of Cardiovascular Relapses by L-Arginine Oral Administration in Patients With CAD and IGT andor Insulin Resistance
Status:
COMPLETED
Status Verified Date:
2006-12
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:
Impaired glucose tolerance or mild glucose elevations in the non-diabetic range are associated with increased cardiovascular disease and recent studies suggested the need to detect these glucose abnormalities early in the post-infarction period Although in the last ten years procedures of coronary revascularisation have dramatically improved the outcome of non diabetic patients affected by ischemic heart disease these procedures are less effective in patients with type 2 diabetes mellitus and IGT Possible causes of worse prognosis in these patients could be related to the presence of hyperinsulinemia and insulin resistance due to the well known effect of insulin to increase neointimal tissue proliferation and in-stent restenosis by stimulating vascular smooth muscle cell growth factors and migration In addition it is well known that endothelial dysfunction is an early functional disturbance in the development of atherosclerotic lesions The impairment of eNOS action might change the turnover rate of eNOS or nitric oxide production and action influencing nitric oxide signalling apoptosis cascade and angiogenesis All these factors can contribute to endothelial dysfunction to a certain extent and accelerate atherosclerosis with increased risk for cardiovascular disease
The constitutively expressed eNOS is likely to be the major contributors to whole-body nitric oxide production It is interesting to note that a region of chromosome 7q seems to influence both insulin resistance and blood pressure suggesting that this locus may broadly influence traits associated with insulin resistance
L-arginine is an essential amino acid and its availability is important for the normal endothelial cell function and its intracellular reduction may contribute to the dysfunctional endothelial state It is well known that L-arginine is as a precursor for nitric oxide and both in vitro and in vivo studies have demonstrated that L-arginine can augment vascular dilation under certain conditions
Our hypothesis is to evaluate the modulating effect of L-arginine on metabolic endothelial variables and on myocardial function in patients with cardiovascular disease
The constitutively expressed eNOS is likely to be the major contributors to whole-body nitric oxide production It is interesting to note that a region of chromosome 7q seems to influence both insulin resistance and blood pressure suggesting that this locus may broadly influence traits associated with insulin resistance
L-arginine is an essential amino acid and its availability is important for the normal endothelial cell function and its intracellular reduction may contribute to the dysfunctional endothelial state It is well known that L-arginine is as a precursor for nitric oxide and both in vitro and in vivo studies have demonstrated that L-arginine can augment vascular dilation under certain conditions
Our hypothesis is to evaluate the modulating effect of L-arginine on metabolic endothelial variables and on myocardial function in patients with cardiovascular disease
Detailed Description:
Condition Patients submitted to coronary revascularization characterized for glucose tolerance after OGTT Intervention L-arginine for 6 months Inclusion criteria patients in stable clinical conditions after coronary revascularization CABG and percutaneous angioplasty withwithout stent implantation Age 30 years male and female Fasting glucose levels below 126 mgdl
Exclusion criteria Type 1 diabetes mellitus known type 2 diabetes mellitus pregnancy impaired kidney and liver function severe and not treated arterial hypertension
Study type randomized double blind Placebo parallel
Exclusion criteria Type 1 diabetes mellitus known type 2 diabetes mellitus pregnancy impaired kidney and liver function severe and not treated arterial hypertension
Study type randomized double blind Placebo parallel
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