Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00314379
Status:
COMPLETED
Last Update Posted:
2009-01-22
First Post:
2006-04-10
Brief Title:
Endothelial Function in a Sample Group of Patients From the ICARE Study
Sponsor:
Technion Israel Institute of Technology
Organization:
Technion Israel Institute of Technology
Study Overview
Official Title:
Vitamin E Treatment and Endothelial Function in Type 2 Diabetic Patients With Hp 2-2 Phenotype From the I CARE Study EFI
Status:
COMPLETED
Status Verified Date:
2009-01
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 ICARE study clinicaltrialsgov ID number NCT00220831 and protocol number KL-2004 is recruiting diabetic patients with haptoglobin phenotype 2-2 which are randomised to either Vitamin E 400IU per day or placebo Patients will be followed for 4 years for the major cardiovascular complications of diabetes acute myocardial infarction MI stroke and cardiovascular mortality see ICARE protocol The EFI study Endothelial Function in ICARE will recruit a sample group of 50 patients from the ICARE cohort These patients will complete all requirements by ICARE protocol and in addition will be tested for endothelial function by a non-invasive method of flow mediated dilatation FMD
Detailed Description:
Fifty patients will be randomly sampled from the ICARE untreated cohort registry of diabetic patients with Hp2-2 phenotype which were not randomised to treatment under ICARE study Patients will be randomised to either vitamin E 400 IUd or Placebo upon sampling for EFI study
The patients will be tested for endothelial function by a method of Post Ischemic Flow mediated Dilatation
all patients will undergo a baseline Endothelial Function test and then start taking the study drug for 2 months at the end of two months of therapy the patients will undergo a second endothelial function test then therapy will be stopped for 2 weeks and a cross over will be performed for an additional 2 months of therapy which in the end the third and final endothelial function test will be done
An interim Results analysis is set to be done once the first 20 patients completed the protocol In case of significant differences between the groups study principal investigators will decide about study completion
The patients will be tested for endothelial function by a method of Post Ischemic Flow mediated Dilatation
all patients will undergo a baseline Endothelial Function test and then start taking the study drug for 2 months at the end of two months of therapy the patients will undergo a second endothelial function test then therapy will be stopped for 2 weeks and a cross over will be performed for an additional 2 months of therapy which in the end the third and final endothelial function test will be done
An interim Results analysis is set to be done once the first 20 patients completed the protocol In case of significant differences between the groups study principal investigators will decide about study completion
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