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

NCT00314379 | Completed Phase 2

• 1 other identifier: HP1980
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Cardiovascular Diseases

Keywords

Diabetes; Endothelial Function; Haptoglobin

Outcome Measures

Primary Outcomes (1)

• Endothelial function by a non-invasive method of FMD

Secondary Outcomes (1)

• 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.

Interventions

Vitamin E 400IU/day DRUG

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetic patients aged 55 and above

You may not qualify if:

• 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.

Sponsors & Collaborators

• Technion, Israel Institute of Technology: lead
• Clalit Health Services: collaborator
• Rambam Health Care Campus: collaborator

Study Sites (1)

Rambam Medical Center

Haifa, Israel

Location

Related Publications (1)

• Asleh R, Blum S, Kalet-Litman S, Alshiek J, Miller-Lotan R, Asaf R, Rock W, Aviram M, Milman U, Shapira C, Abassi Z, Levy AP. Correction of HDL dysfunction in individuals with diabetes and the haptoglobin 2-2 genotype. Diabetes. 2008 Oct;57(10):2794-800. doi: 10.2337/db08-0450. Epub 2008 Jul 3.

  PMID: 18599520 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus

Interventions

Vitamin E

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 10, 2006
• First Posted: April 13, 2006
• Study Start: April 1, 2006
• Study Completion: December 1, 2007
• Last Updated: January 22, 2009

Record last verified: 2009-01

Locations

IL (1)