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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Vitamin E 400IU/day

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No