Type 2 Diabetes Haptoglobin Phenotype and Vitamin E

NCT01113671 | Completed Phase 2

• 1 other identifier: HDL005
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus Type 2

Keywords

Diabetes Mellitus type 2; Haptoglobin phenotype; Vitamin E

Outcome Measures

Primary Outcomes (1)

• Reverse Cholesterol transport of the HDL

  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.

  3 months

Secondary Outcomes (3)

• HDL oxidation

  3 months

• HDL structure

  3 months

• Serum inflammatory markers

  3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

d-alpha-tocopheryl acetate

EXPERIMENTAL

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

Interventions

Vitamin E (d-alpha-tocopheryl acetate) DRUG

100% natural source d-alpha-tocopheryl acetate in a soft gel cap

d-alpha-tocopheryl acetate

Placebo DRUG

includes inactive Ingredients

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age 55 and above.
• Ability to communicate and comply with all study requirements.
• Able to understand content of informed consent, and has provided written informed consent.
• 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.

You may not qualify if:

• Known allergy to vitamin E.
• Active cardiovascular disease (active stable/unstable angina, less then one year post MI or stroke prior to randomization).
• 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.
• Platelet count \<100,000 mm3 and/or abnormal prothrombin or partial thromboplastin time at baseline.
• Active inflammatory conditions which are likely to require intervention during the course of the study or are regarded as clinically meaningful by the investigator.
• Active and or treated malignancies within 12 months prior to randomization with the exception of basal cell or squamous cell carcinoma.
• Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
• 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).
• 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.
• History of noncompliance to medical regimens, or subjects unwilling to comply with the study protocol.
• Administration of any antioxidant vitamins or drugs including vitamin E and not willing to withdrawal and washout for one month prior to enrollment.
• 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.

Sponsors & Collaborators

• Technion, Israel Institute of Technology: lead

Study Sites (1)

Laboratory of Vascular Medicine, Technion Faculty of Medicine

Haifa, Israel

Location

Related Publications (1)

• Farbstein D, Blum S, Pollak M, Asaf R, Viener HL, Lache O, Asleh R, Miller-Lotan R, Barkay I, Star M, Schwartz A, Kalet-Littman S, Ozeri D, Vaya J, Tavori H, Vardi M, Laor A, Bucher SE, Anbinder Y, Moskovich D, Abbas N, Perry N, Levy Y, Levy AP. Vitamin E therapy results in a reduction in HDL function in individuals with diabetes and the haptoglobin 2-1 genotype. Atherosclerosis. 2011 Nov;219(1):240-4. doi: 10.1016/j.atherosclerosis.2011.06.005. Epub 2011 Jun 13.

  PMID: 21722898 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vitamin E; alpha-Tocopherol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tocopherols

Study Officials

• Shany Blum, MD PhD

  Technion, Israel Institute of Technology

  STUDY DIRECTOR

• Andrew Levy, MD PhD

  Technion, Israel Institute of Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 28, 2010
• First Posted: April 30, 2010
• Study Start: January 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: January 1, 2011
• Last Updated: January 11, 2011

Record last verified: 2011-01

Locations

IL (1)