Type 2 Diabetes Haptoglobin Phenotype and Vitamin E (IDEAL2)

This study has been completed.
Sponsor:
Information provided by:
Technion, Israel Institute of Technology
ClinicalTrials.gov Identifier:
NCT01113671
First received: April 28, 2010
Last updated: January 10, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus Type 2
Drug: Vitamin E (d-alpha-tocopheryl acetate)
Drug: Placebo
Phase 2
Phase 3

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
Official 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)

Resource links provided by NLM:


Further study details as provided by Technion, Israel Institute of Technology:

Primary Outcome Measures:
  • Reverse Cholesterol transport of the HDL [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Reverse Cholesterol transport of the HDL will be assessed using patients' serum samples in a specified in vitro laboratory assay on baseline, after the first treatment and after the second treatment, Vitamin E treatment effect on this molecular marker will be compared between the 3 different Haptoglobin phenotype patients groups.


Secondary Outcome Measures:
  • HDL oxidation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    HDL oxidation will be assessed using patients' serum samples in a specified in vitro laboratory assay on baseline, after the first treatment and after the second treatment, Vitamin E treatment effect on this molecular marker will be compared between the 3 different Haptoglobin phenotype patients groups.

  • HDL structure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    HDL structure will be assessed using patients' serum samples in a specified in vitro laboratory assay on baseline, after the first treatment and after the second treatment, Vitamin E treatment effect on this molecular marker will be compared between the 3 different Haptoglobin phenotype patients groups.

  • Serum inflammatory markers [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Serum inflammatory markers will be assessed using patients' serum samples in a specified in vitro laboratory assay on baseline, after the first treatment and after the second treatment, Vitamin E treatment effect on these molecular markers will be compared between the 3 different Haptoglobin phenotype patients groups.


Estimated Enrollment: 90
Study Start Date: January 2009
Study Completion Date: January 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
includes inactive Ingredients
Experimental: d-alpha-tocopheryl acetate Drug: Vitamin E (d-alpha-tocopheryl acetate)
100% natural source d-alpha-tocopheryl acetate in a soft gel cap

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01113671

Locations
Israel
Laboratory of Vascular Medicine, Technion Faculty of Medicine
Haifa, Israel
Sponsors and Collaborators
Technion, Israel Institute of Technology
Investigators
Study Director: Shany Blum, MD PhD Technion, Israel Institute of Technology
Study Chair: Andrew Levy, MD PhD Technion, Israel Institute of Technology
  More Information

No publications provided by Technion, Israel Institute of Technology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Shany Blum, Laboratory of Vascular Medicine, Faculty of Medicine, Technion - Israel Institute of Technology
ClinicalTrials.gov Identifier: NCT01113671     History of Changes
Other Study ID Numbers: HDL005
Study First Received: April 28, 2010
Last Updated: January 10, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Technion, Israel Institute of Technology:
Diabetes Mellitus type 2
Haptoglobin phenotype
Vitamin E

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vitamins
Tocopherols
Vitamin E
Alpha-Tocopherol
Tocotrienols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on September 30, 2014