Endothelial Function in a Sample Group of Patients From the ICARE Study
The ICARE study, clinicaltrials.gov 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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Vitamin E Treatment and Endothelial Function in Type 2 Diabetic Patients With Hp 2-2 Phenotype From the I CARE Study (EFI)|
- Endothelial function by a non-invasive method of FMD
- Predefined in the protocol submitted to the EC approved prior to study beginning and the Inform Consent Form signed by all study participants prior to study related procedures, serum was preserved for the analysis of oxidative and inflammatory markers. [ Designated as safety issue: No ]
|Study Start Date:||April 2006|
|Study Completion Date:||December 2007|
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 IU/d 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.
|Rambam Medical Center|
|Principal Investigator:||Shany Blum, M.D. M.Sc.||Technion, Israel Institute of Technology|
|Principal Investigator:||Uzi Milman, M.D.||Clalit Health Services|
|Principal Investigator:||Chen Shapira, M.D.||Clalit Health Services|
|Principal Investigator:||Giris Jacob, M.D. Ph.D.||Rambam Health Care Campus|
|Principal Investigator:||Lior Dayan, M.D. M.Sc.||Rambam Health Care Campus|
|Principal Investigator:||Andrew P Levy, M.D. Ph.D.||Technion, Israel Institute of Technology|