Status:
COMPLETED
Endothelial Function in a Sample Group of Patients From the ICARE Study
Lead Sponsor:
Technion, Israel Institute of Technology
Collaborating Sponsors:
Clalit Health Services
Rambam Health Care Campus
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
55+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 p...
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 ...
Eligibility Criteria
Inclusion
- Diabetic patients aged 55 and above
Exclusion
- Patient who takes antioxidant treatment will be asked to stop, or cannot be included in the study.
- Patients who had a cardiovascular disease (CVD) incident (myocardial infarction \[MI\], stroke, transient ischemic attack \[TIA\]), unstable angina pectoris, uncontrolled hypertension (HTN), will have to wait a month after stabilization to be included in the study.
- Allergy to vitamin E.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00314379
Start Date
April 1 2006
End Date
December 1 2007
Last Update
January 22 2009
Active Locations (1)
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1
Rambam Medical Center
Haifa, Israel