Haptoglobin Phenotype, Vitamin E and High-density Lipoprotein (HDL) Function in Type 1 Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 30 - Any |
| Updated: | 5/3/2014 |
| Start Date: | February 2010 |
| End Date: | December 2011 |
| Contact: | Tina Costacou, PhD |
| Email: | CostacouT@edc.pitt.edu |
| Phone: | 412-383-2062 |
Pilot and Feasibility Study for a Pharmacogenomic Trial in Type 1 Diabetes
The purpose of the study is to determine whether the function of the good cholesterol (HDL
cholesterol) is altered among people with type 1 diabetes and a variation in the Haptoglobin
gene and to evaluate whether vitamin E supplements may improve this function.
cholesterol) is altered among people with type 1 diabetes and a variation in the Haptoglobin
gene and to evaluate whether vitamin E supplements may improve this function.
Persons with type 1 diabetes are at a much greater risk for heart disease compared to the
general population. Among individuals with diabetes, those with a specific variation in a
genetic marker called Haptoglobin (approximately 43% of persons with type 1 diabetes) are at
even greater risk compared to those not carrying this genetic variation. A genetic marker
or a "gene" is information inherited from parents (a blueprint) about the structure and
functions of cells in the body that make up the color of our hair and eyes and may influence
the way our bodies respond to certain stimuli such as an illness, or infection.
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), 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.
general population. Among individuals with diabetes, those with a specific variation in a
genetic marker called Haptoglobin (approximately 43% of persons with type 1 diabetes) are at
even greater risk compared to those not carrying this genetic variation. A genetic marker
or a "gene" is information inherited from parents (a blueprint) about the structure and
functions of cells in the body that make up the color of our hair and eyes and may influence
the way our bodies respond to certain stimuli such as an illness, or infection.
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), 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.
Inclusion Criteria:
- Individuals with type 1 diabetes residing in the Pittsburgh, PA area (members of the
Allegheny Count or Children's Hospital of Pittsburgh/Epidemiology of Diabetes
Complications Registries)
- 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:
- Allergy to vitamin E
- Stroke, MI within the past 6 months
- Unwillingness/inability to limit antioxidant supplement use to study-provided
supplements
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