Prevention of Diabetic Cardiovascular Complications With Vitamin E 400 IU Treatment to High Risk Patients by Haptoglobin Phenotype (I CARE - Israel Cardiovascular Atherosclerosis Risk and Vitamin E)
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 2,000
- Locations
- 1
- Primary Endpoint
- A combination of CVD mortality non fatal MI and Stoke at a 4 year follow up.
Study Overview
Brief Summary
The purpose of this study is to determine whether Vitamin E treatment to Diabetic patients, who carry the Haptoglobin 2-2 Phenotype, prevents cardiovascular complications such as acute MI and Stroke.
Detailed Description
Haptoglobin is a free Hemoglobin scavenger protein. Hemoglobin is an oxidant due to the Fe it carries by the Fenton reaction. Thus it is believed that Haptoglobin is an antioxidant, especially in the site of vascular injury.
Haptoglobin has three phenotype easily identified by a method of gel electrophoresis.
The three phenotype denote as 1-1, 2-1 and 2-2. We have found in several in vitro studies in our lab that Haptoglobin 1-1 is a superior antioxidant over 2-2.
In several large retrospective studies we found that Diabetic patients who are Haptoglobin typed 2-2 have a 5 time risk of having cardiovascular complications (acute MI, CVA, CVD death) over the ones who are Haptoglobin 1-1.
2-1 patients are probably at intermediate risk. While retrospectively typing consecutive serums from patients who participate the HOPE study we found that taking Vitamin E decreased by 50% the CVD incidences of Diabetic patients with the Haptoglobin 2-2 phenotype.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diabetic patients aged 55 and above
Exclusion Criteria
- •Patient who takes antioxidant treatment will be asked to stop, or can't be included in the study
- •Patients who had a CVD incident (MI, Stroke, TIA), Unstable angina pectoris, Uncontrolled HTN, will have to wait a month after stabilization to be included in the study
- •Allergy to Vitamin E
Outcomes
Primary Outcomes
A combination of CVD mortality non fatal MI and Stoke at a 4 year follow up.
Secondary Outcomes
- Cardiac Interventions (Angioplasty, Bypass surgery
- etc…), all cause mortality, heart failure, at a 4 year follow up.