Type 2 Diabetes Haptoglobin Phenotype and Vitamin E

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01113671
• Date of registration: 28/04/2010
• Prospective Registration: No
• Primary sponsor: Technion, Israel Institute of Technology
• Public title: Type 2 Diabetes Haptoglobin Phenotype and Vitamin E IDEAL2
• Scientific title: Evaluating the Effect of Vitamin E Treatment on HDL Function of Type 2 Diabetic Patients and the Correlation to Hp Phenotype. A Prospective, Double Blind, Randomized, Placebo Controlled Trial (IDEAL2 Study)
• Date of first enrolment: January 2009
• Target sample size: 90
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01113671
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
• Phase: Phase 2/Phase 3

Countries of recruitment

Israel

Contacts

• Name: Andrew Levy, MD PhD
• Affiliation: Technion, Israel Institute of Technology

• Name: Shany Blum, MD PhD
• Affiliation: Technion, Israel Institute of Technology

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female age 55 and above.

2. Ability to communicate and comply with all study requirements.

3. Able to understand content of informed consent, and has provided written informed
consent.

4. Do not take any antioxidant vitamin or drugs including vitamin E, also including all
kind of herbal medicines or homeopathic medicine, patients taking such drugs will
have to agree to withdrawal from the drug and will be eligible for recruitment after
one month of washout.

Exclusion Criteria:

1. Known allergy to vitamin E.

2. Active cardiovascular disease (active stable/unstable angina, less then one year post
MI or stroke prior to randomization).

3. Hematological (hemoglobin <10 g/dL), hepatic (aspartate aminotransferase or alanine
aminotransferase values >2 x upper limit of normal), or renal disease (serum
creatinine >2.5 mg/dL) at baseline.

4. Platelet count <100,000 mm3 and/or abnormal prothrombin or partial thromboplastin
time at baseline.

5. Active inflammatory conditions which are likely to require intervention during the
course of the study or are regarded as clinically meaningful by the investigator.

6. Active and or treated malignancies within 12 months prior to randomization with the
exception of basal cell or squamous cell carcinoma.

7. Any surgical or medical condition which might significantly alter the absorption,
distribution, metabolism, or excretion of any drug.

8. Recent history of (within past 12 months) alcohol or substance abuse. Alcohol abuse
will be defined as >14 drinks per week (1 drink = 12 oz beer, 4 oz wine, or 1.5 oz
distilled spirits).

9. Female subjects who are not either post-menopausal for one year or surgically
sterile, and who are not using effective contraceptive methods such as barrier method
with spermicidal or an intra-uterine device.

10. History of noncompliance to medical regimens, or subjects unwilling to comply with
the study protocol.

11. Administration of any antioxidant vitamins or drugs including vitamin E and not
willing to withdrawal and washout for one month prior to enrollment.

12. Administration of any investigational drug within 30 days of planned enrollment into
this study.

- criteria 3,4 will be determined using latest blood tests done in the health plan
by the primary physician, patients will be asked to supply those results.

- all other criteria will be assessed based on patient telephone interview.



Age minimum: 55 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus Type 2

Intervention(s)

Drug: Placebo

Drug: Vitamin E (d-alpha-tocopheryl acetate)

Primary Outcome(s)

Reverse Cholesterol transport of the HDL [Time Frame: 3 months]

Secondary Outcome(s)

HDL oxidation [Time Frame: 3 months]

Serum inflammatory markers [Time Frame: 3 months]

HDL structure [Time Frame: 3 months]

Secondary ID(s)

HDL005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors