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

NCT00314379 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2009-01-22

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Vitamin E 400IU/day

Sponsors & Collaborators

  • Clalit Health Services

    collaborator OTHER

  • Rambam Health Care Campus

    collaborator OTHER

  • Technion, Israel Institute of Technology

    lead OTHER

Principal Investigators

  • Shany Blum, M.D. M.Sc. · Technion, Israel Institute of Technology

  • Uzi Milman, M.D. · Clalit Health Services

  • Chen Shapira, M.D. · Clalit Health Services

  • Giris Jacob, M.D. Ph.D. · Rambam Health Care Campus

  • Lior Dayan, M.D. M.Sc. · Rambam Health Care Campus

  • Andrew P Levy, M.D. Ph.D. · Technion, Israel Institute of Technology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Completion
2007-12-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00314379 on ClinicalTrials.gov