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

This study has been completed.
Sponsor:
Collaborators:
Clalit Health Services
Rambam Health Care Campus
Information provided by:
Technion, Israel Institute of Technology
ClinicalTrials.gov Identifier:
NCT00314379
First received: April 10, 2006
Last updated: January 20, 2009
Last verified: January 2009
  Purpose

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).


Condition Intervention Phase
Cardiovascular Diseases
Drug: Vitamin E 400IU/day
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Vitamin E Treatment and Endothelial Function in Type 2 Diabetic Patients With Hp 2-2 Phenotype From the I CARE Study (EFI)

Resource links provided by NLM:


Further study details as provided by Technion, Israel Institute of Technology:

Primary Outcome Measures:
  • Endothelial function by a non-invasive method of FMD

Secondary Outcome Measures:
  • 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. [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2006
Study Completion Date: December 2007
Detailed 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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314379

Locations
Israel
Rambam Medical Center
Haifa, Israel
Sponsors and Collaborators
Technion, Israel Institute of Technology
Clalit Health Services
Rambam Health Care Campus
Investigators
Principal Investigator: Shany Blum, M.D. M.Sc. Technion, Israel Institute of Technology
Principal Investigator: Uzi Milman, M.D. Clalit Health Services
Principal Investigator: Chen Shapira, M.D. Clalit Health Services
Principal Investigator: Giris Jacob, M.D. Ph.D. Rambam Health Care Campus
Principal Investigator: Lior Dayan, M.D. M.Sc. Rambam Health Care Campus
Principal Investigator: Andrew P Levy, M.D. Ph.D. Technion, Israel Institute of Technology
  More Information

No publications provided by Technion, Israel Institute of Technology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00314379     History of Changes
Other Study ID Numbers: HP1980
Study First Received: April 10, 2006
Last Updated: January 20, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Technion, Israel Institute of Technology:
Diabetes
Endothelial Function
Haptoglobin

Additional relevant MeSH terms:
Cardiovascular Diseases
Vitamin E
Vitamins
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 22, 2014