Haptoglobin Phenotype, Vitamin E and High-density Lipoprotein (HDL) Function in Type 1 Diabetes
NCT ID: NCT01098994
Last Updated: 2014-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
87 participants
INTERVENTIONAL
2010-02-28
2013-12-31
Brief Summary
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Detailed Description
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In this project we are seeking to understand what some of the mechanisms may be that put persons with type 1 diabetes and this variation in the Haptoglobin gene at greater risk for heart disease. Specifically, we will assess whether this gene variant affects the function of the good cholesterol (HDL cholesterol) and its subfractions (via NMR spectroscopy), which is thought to help against heart disease development. We also seek to evaluate whether vitamin E supplements may improve this function. If results indicate that vitamin E is beneficial and improves the function of HDL cholesterol, the next question to be answered would be whether vitamin E would also help reduce the risk of heart disease itself in these persons. To answer the latter, a large clinical trial would have to take place. In this research project we will therefore also evaluate whether such a trial would be feasible and whether individuals with type 1 diabetes would be interested in participating in a long, 4-5 year, clinical trial.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Haptoglobin 1/1
Individuals with type 1 diabetes and the Haptoglobin 1/1 phenotype
Vitamin E
Daily administration of 400 IU natural d-alpha tocopherol acetate for 8 weeks
Dummy pills
Daily placebo administration for 8 weeks
Haptoglobin 2/1
Individuals with type 1 diabetes and the Haptoglobin 2/1 phenotype
Vitamin E
Daily administration of 400 IU natural d-alpha tocopherol acetate for 8 weeks
Dummy pills
Daily placebo administration for 8 weeks
Haptoglobin 2/2
Individuals with type 1 diabetes and the Haptoglobin 2/2 phenotype
Vitamin E
Daily administration of 400 IU natural d-alpha tocopherol acetate for 8 weeks
Dummy pills
Daily placebo administration for 8 weeks
Interventions
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Vitamin E
Daily administration of 400 IU natural d-alpha tocopherol acetate for 8 weeks
Dummy pills
Daily placebo administration for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 30 years old or older
* with diabetes duration greater than 10 years or less than 10 years but with a history of heart disease
Exclusion Criteria
* Stroke, MI within the past 6 months
* Unwillingness/inability to limit antioxidant supplement use to study-provided supplements
30 Years
ALL
No
Sponsors
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American Diabetes Association
OTHER
University of Pittsburgh
OTHER
Responsible Party
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Tina Costacou
Assistant Professor of Epidemiology
Principal Investigators
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Tina Costacou, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Pittsburgh Diabetes and Lipid Research Clinic
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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1-10-CT-12
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
1-10-CT-12
Identifier Type: -
Identifier Source: org_study_id
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