Haptoglobin Phenotype and Cardiovascular Complications in Diabetic Patients

Completed

• Conditions: Myocardial Infarction; Diabetes; Cardiovascular Disease

• Registration Number: NCT00448487
• Lead Sponsor: Dr. Shany Blum

Brief Summary

3054 diabetic patients were screened for Haptoglobin Phenotype as part of the ICARE study (NCT00220831) and composite the I CARE Registry, 1434 Hp 2-2 patients were treated as part of the I CARE study with vitamin E vs. Placebo, this study was recently terminated due to significant differences between the groups and data was sent to publication. All other patients were passively followed since April 2005 for cardiovascular events. We have decided to continue and follow these patients till end of December 2007 to determine the incidence of CVD in theses patients which are pre stratified by Haptoglobin Phenotype.

Detailed Description

3054 diabetic patients from Clalit Medical Services were screened for Haptoglobin Phenotype as part of the ICARE study (NCT00220831) and composite the I CARE registry, 1434 Hp 2-2 patients were treated as part of the I CARE study with vitamin E vs. Placebo, this study was recently terminated due to significant differences between the groups and data was sent to publication.

During the follow up period of the I CARE study all 3054 registry patients were followed in a passive way, which means that the patients were not called for follow up visits but the reports for CVD events were centrally collected from patient's Hospital admission summaries. Admission summaries were collected using the computerized systems of the Clalit Health Services assuring that when ever a patient in the registry is hospitalized for what ever reason the study coordination them would be aware of that and receive the admission summary. An events adjudication committee adjudicated each event in a blinded fashion to determine the nature of the events.

1434 patients who were treated by vitamin E or placebo in the I CARE study were also followed by follow-up telephone calls.

once I CARE study was officially terminated we have decided to continue and follow the whole 3054 registry patients in the same manner to complete a nearly 3 year follow up to determine in a prospective manner the incidence of CVD events in Diabetic patients which were pre-stratified by Haptoglobin type.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2007-03-14
• Study First Submitted QC: 2007-03-15
• Study First Posted: 2007-03-16
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-10
• Last Update Posted: 2015-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3054

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
same as in ICARE: composite major CVD outcomes (non fatal MI, Stroke and CVD death)	Continuously till end of June 2008

Trial Locations

Locations (1)

Clalit Health Services, Haifa and Western Galilee District; 🇮🇱 Haifa, Israel