Type 2 Diabetes Haptoglobin Phenotype and Vitamin E

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a biomarker exploratory study which is designed to investigate the function and oxidation of the high density lipoprotein (HDL) (the good cholesterol) in patients with type 2 diabetes mellitus treated with Vitamin E versus placebo and segregated by the type of the Haptoglobin protein they have in their blood.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technion, Israel Institute of Technology
• Treatments: alpha-Tocopherol; Tocopherols; Tocotrienols; Vitamin E; Vitamins

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.