IDEAL2
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)
Sponsor study identifier
interventional
90
1 country
1
Study Start
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2010
Actual (reported)Study Completion
January 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
April 28, 2010
Actual (reported)April 30, 2010
Actual (reported)July 2010
Actual (reported)January 2011
Actual (reported)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
HDL oxidation
3 months
HDL structure
3 months
Serum inflammatory markers
3 months
100% natural source d-alpha-tocopheryl acetate in a soft gel cap
includes inactive Ingredients
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Laboratory of Vascular Medicine, Technion Faculty of Medicine
Haifa, Israel
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.
Shany Blum, MD PhD
Technion, Israel Institute of Technology
Andrew Levy, MD PhD
Technion, Israel Institute of Technology
First Submitted
April 28, 2010
First Posted
April 30, 2010
Study Start
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2010
Actual (reported)Contact the study team to confirm eligibility.
Study Completion
January 2011
Actual (reported)Last Updated
January 11, 2011
Record last verified: 2011-01
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Source: ClinicalTrials.gov.
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