Clinical trial NCT00314379: Endothelial Function in a Sample Group of Patients From the ICARE Study
Official title: Vitamin E Treatment and Endothelial Function in Type 2 Diabetic Patients With Hp 2-2 Phenotype From the I CARE Study (EFI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cardiovascular Diseases
Keywords: Diabetes
Endothelial Function
Haptoglobin
Lead sponsor: Technion, Israel Institute of Technology
Sponsor class: OTHER
Collaborators: name: Clalit Health Services
name: Rambam Health Care Campus
First posted: 2006-04-13
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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 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.

Primary outcomes:
measure: Endothelial function by a non-invasive method of FMD
Secondary outcomes:
measure: 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.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Technion, Israel Institute of Technology
name: Shany Blum, M.D. M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clalit Health Services
name: Uzi Milman, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clalit Health Services
name: Chen Shapira, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus
name: Giris Jacob, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus
name: Lior Dayan, M.D. M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Technion, Israel Institute of Technology
name: Andrew P Levy, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.