Endothelial Function in a Sample Group of Patients From the ICARE Study

Cardiovascular Diseases Clinical Trial

Official title:

Vitamin E Treatment and Endothelial Function in Type 2 Diabetic Patients With Hp 2-2 Phenotype From the I CARE Study (EFI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314379
• Other study ID #: HP1980
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 10, 2006
• Last updated: January 20, 2009
• Start date: April 2006
• Est. completion date: December 2007

Study information

• Verified date: January 2009
• Source: Technion, Israel Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The ICARE study, clinicaltrials.gov ID number: NCT00220831 and protocol number KL-2004, is recruiting diabetic patients with haptoglobin phenotype 2-2, which are randomised to either Vitamin E 400IU per day or placebo. Patients will be followed for 4 years for the major cardiovascular complications of diabetes, acute myocardial infarction (MI), stroke and cardiovascular mortality (see ICARE protocol). The EFI study, Endothelial Function in ICARE will recruit a sample group of 50 patients from the ICARE cohort. These patients will complete all requirements by ICARE protocol and in addition will be tested for endothelial function by a non-invasive method of flow mediated dilatation (FMD).

Description:

Fifty patients will be randomly sampled from the ICARE untreated cohort (registry) of diabetic patients with Hp2-2 phenotype which were not randomised to treatment under ICARE study. Patients will be randomised to either vitamin E 400 IU/d or Placebo upon sampling for EFI study.

The patients will be tested for endothelial function by a method of Post Ischemic Flow mediated Dilatation.

all patients will undergo a baseline Endothelial Function test and then start taking the study drug for 2 months. at the end of two months of therapy the patients will undergo a second endothelial function test, then therapy will be stopped for 2 weeks and a cross over will be performed for an additional 2 months of therapy which in the end the third and final endothelial function test will be done.

An interim Results analysis is set to be done once the first 20 patients completed the protocol. In case of significant differences between the groups, study principal investigators will decide about study completion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Diabetic patients aged 55 and above

Exclusion Criteria:

• Patient who takes antioxidant treatment will be asked to stop, or cannot be included in the study.

• Patients who had a cardiovascular disease (CVD) incident (myocardial infarction [MI], stroke, transient ischemic attack [TIA]), unstable angina pectoris, uncontrolled hypertension (HTN), will have to wait a month after stabilization to be included in the study.

• Allergy to vitamin E.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Drug:
• Vitamin E 400IU/day

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (3)

Lead Sponsor	Collaborator
Technion, Israel Institute of Technology	Clalit Health Services, Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial function by a non-invasive method of FMD
Secondary	Predefined in the protocol submitted to the EC approved prior to study beginning and the Inform Consent Form signed by all study participants prior to study related procedures, serum was preserved for the analysis of oxidative and inflammatory markers.			No