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Sponsors and Collaborators: |
Technion, Israel Institute of Technology Clalit Health Services Kennedy-Leigh charitable trust |
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Information provided by: | Technion, Israel Institute of Technology |
ClinicalTrials.gov Identifier: | NCT00220831 |
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.
Condition | Intervention | Phase |
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Diabetes Myocardial Infarction Cardiovascular Disease |
Drug: Natural source Vitamin E 400IU/day |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | 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) |
Estimated Enrollment: | 2000 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | December 2009 |
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. Based on these findings we wish to perform the I CARE study. 5000 diabetic patients aged 55 and above, will be tested for Haptoglobin phenotype.
Knowing the distribution of the different Haptoglobin phenotypes in the Israeli population we estimate that about 2000 will be of the phenotype 2-2. These 2000 patients will be enrolled in a prospective, doubled blind, randomized and placebo controlled clinical study and will be randomly divided into 2 groups, one receiving Vitamin E 400IU per day and the other receiving matching placebo.
All patients will be followed routinely by their primary physicians in Clalit HMO (the biggest HMO in Israel) in a routine diabetes follow up and treatment (HbA1c, blood pressure control, Lipids, renal function, eye exam for retinopathy etc…) The study steering committee will get anamnestic data and routine tests results every 3 months.
Primary Outcomes: a combination of CVD mortality and non fatal MI and Stroke. Secondary Outcomes: Cardiac Interventions (Angioplasty, Bypass surgery etc…), all cause mortality, heart failure.
Exclusion criteria: 1) patient who takes antioxidant treatment will be asked to stop, or can't be included in the study.
2) 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. 3) Allergy to Vitamin E. Follow up duration – 4.5 years. 5% percent of all vitamin receivers will be tested at base line and a year after enrollment, for Vitamin E plasma concentration.
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Israel | |
Clalit Health Services, Haifa and West Galilee - primary health care clinics, in the north of Israel And the Bruce Rappaport Faculty of Medicine, Technion, Haifa, Israel. | |
Haifa, Israel |
Principal Investigator: | Uzi Milman, MD | Clalit Health Services |
Study Chair: | Chen Shapira, MD | Clalit Health Services |
Study Chair: | Shany Blum, MD MSc | Laboratory of Vascular Medicine, the Bruce Rappaport Faculty of Medicine, Technion – Israel Institute of Technology. |
Study Chair: | Andrew P Levy, MD PhD | Laboratory of Vascular Medicine, the Bruce Rappaport Faculty of Medicine, Technion – Israel Institute of Technology. |
Study ID Numbers: | KL-2004 |
Study First Received: | September 13, 2005 |
Last Updated: | February 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00220831 History of Changes |
Health Authority: | Israel: Ministry of Health |
Diabetes MI CVD disease |
Atherosclerosis Tocopherol acetate Antioxidants Heart Diseases Myocardial Ischemia Diabetes Mellitus Vascular Diseases Trace Elements Ischemia |
Alpha-Tocopherol Tocopherols Necrosis Vitamin E Vitamins Tocotrienols Micronutrients Infarction Myocardial Infarction |
Tocopherol acetate Antioxidants Heart Diseases Molecular Mechanisms of Pharmacological Action Growth Substances Myocardial Ischemia Physiological Effects of Drugs Vascular Diseases Ischemia Protective Agents Pharmacologic Actions |
Alpha-Tocopherol Tocopherols Necrosis Vitamin E Pathologic Processes Vitamins Tocotrienols Cardiovascular Diseases Micronutrients Infarction Myocardial Infarction |