## Protocol Section
### Identification Module
**NCT ID:** NCT00314379

**Brief Title:** 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)

#### Organization Study ID Info
**ID:** HP1980
#### Organization
**Class:** OTHER
**Full Name:** Technion, Israel Institute of Technology
### Status Module
#### Completion Date
**Date:** 2007-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2009-01-22

**Type:** ESTIMATED

**Last Update Submit Date:** 2009-01-20

**Overall Status:** COMPLETED

#### Start Date
**Date:** 2006-04

**Status Verified Date:** 2009-01

#### Study First Post Date
**Date:** 2006-04-13
**Type:** ESTIMATED
**Study First Submit Date:** 2006-04-10
**Study First Submit QC Date:** 2006-04-12
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Clalit Health Services

**Class:** OTHER

**Name:** Rambam Health Care Campus

#### Lead Sponsor

**Class:** OTHER

**Name:** Technion, Israel Institute of Technology

### Description Module

**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.

### Conditions Module

**Conditions:**

- Cardiovascular Diseases

**Keywords:**

- Diabetes

- Endothelial Function

- Haptoglobin

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- PHASE2

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Vitamin E 400IU/day

**Type:** DRUG

### Outcomes Module

#### 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.

### Eligibility Module

**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.

**Minimum Age:** 55 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Haifa

**Country:** Israel

**Facility:** Rambam Medical Center

#### Overall Officials

**Official 1:**

**Affiliation:** Technion, Israel Institute of Technology

**Name:** Shany Blum, M.D. M.Sc.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Clalit Health Services

**Name:** Uzi Milman, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Clalit Health Services

**Name:** Chen Shapira, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 4:**

**Affiliation:** Rambam Health Care Campus

**Name:** Giris Jacob, M.D. Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 5:**

**Affiliation:** Rambam Health Care Campus

**Name:** Lior Dayan, M.D. M.Sc.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 6:**

**Affiliation:** Technion, Israel Institute of Technology

**Name:** Andrew P Levy, M.D. Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### 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.

**PMID:** 18599520

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: T4694

- Name: Primary Hyperoxaluria Type 2

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002318

- Term: Cardiovascular Diseases

### Intervention Browse Module - Ancestors

- ID: D000014815

- Term: Vitamins

- ID: D000018977

- Term: Micronutrients

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000975

- Term: Antioxidants

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000020011

- Term: Protective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M22972

- Name: Tocopherols

- Relevance: LOW

- As Found: Unknown

- ID: M17553

- Name: Vitamin E

- Relevance: HIGH

- As Found: Untreated

- ID: M22975

- Name: Tocotrienols

- Relevance: LOW

- As Found: Unknown

- ID: M22969

- Name: alpha-Tocopherol

- Relevance: LOW

- As Found: Unknown

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: M21009

- Name: Micronutrients

- Relevance: LOW

- As Found: Unknown

- ID: M16885

- Name: Trace Elements

- Relevance: LOW

- As Found: Unknown

- ID: M4292

- Name: Antioxidants

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: T466

- Name: Tocopherol

- Relevance: LOW

- As Found: Unknown

- ID: T467

- Name: Tocotrienol

- Relevance: LOW

- As Found: Unknown

- ID: T480

- Name: Vitamin E

- Relevance: HIGH

- As Found: Untreated

### Intervention Browse Module - Meshes

- ID: D000014810

- Term: Vitamin E

### Misc Info Module

- Version Holder: 2024-05-24
