Haptoglobin Phenotype and Cardiovascular Complications in Diabetic Patients

Diabetes Clinical Trial

— ICARER  

Official title:

Prospective Observational Study to Asses the Incidence of CVD Complications in Diabetic Patients Pre-stratified by Haptoglobin Phenotype From the I CARE Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448487
• Other study ID #: KL-2007
• Status: Completed
• Phase: N/A
• First received: March 14, 2007
• Last updated: June 10, 2015
• Start date: April 2005
• Est. completion date: June 2008

Study information

• Verified date: June 2015
• Source: Technion, Israel Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3054
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

These are the same patients as in I CARE registry so the criteria are the same as was for I CARE study Recruitment phase.

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes
• Myocardial Infarction

Locations

Country	Name	City	State
Israel	Clalit Health Services, Haifa and Western Galilee District	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Shany Blum	Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	same as in ICARE: composite major CVD outcomes (non fatal MI, Stroke and CVD death)		Continuously till end of June 2008	No