Clinical trial NCT00448487: Haptoglobin Phenotype and Cardiovascular Complications in Diabetic Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Cardiovascular Disease
Myocardial Infarction
Keywords: Diabetes
Cardiovascular Disease
Haptoglobin
Lead sponsor: Technion, Israel Institute of Technology
Sponsor class: OTHER
Collaborators: name: Clalit Health Services
First posted: 2007-03-16
Enrollment: 3054
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients recruited from primary care clinics. all are diabetic patients 55 years old or older.

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.

Eligibility criteria: 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

Primary outcomes:
measure: same as in ICARE: composite major CVD outcomes (non fatal MI, Stroke and CVD death)
timeFrame: Continuously till end of June 2008
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Clalit Health Services, Haifa and Western Galilee District
Study officials:
affiliation: Technion, Israel Institute of Technology
name: Shany Blum, M.D. M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clalit Health Services
name: Uzi Milman, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clalit Health Services
name: Chen Shapira, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Technion, Israel Institute of Technology
name: Andrew P Levy, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: