Genetics Of Autoimmunity In Type I Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to gain more information about the step-by-step process that causes someone to develop type 1 diabetes. Scientists think that a person's own immune system, directed by genetic and environmental factors play a major role in its development. Participation involves a blood draw, a brief medical history questionnaire and measurements of height and weight. Some participants will be asked to return for annual follow-up visits for 10 years.

Detailed Description
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The goal of this project is to gain knowledge about the development of Type 1 diabetes (T1D), as T1D is one of the most common chronic diseases in children. There has been a rise in the number of cases diagnosed as well as a decrease in the age of diagnosis. This project aims to understand the disease progression as seen in the immune system and to define the genetic and environmental factors that affect inflammation and regulation, which could determine disease progression or nonprogression. Families that include a family member with T1D will be recruited, as well as unrelated, healthy controls as a comparison group. Participants will have height and weight measured, complete a social & medical history questionnaire, and have blood drawn for analysis for HLA haplotype (a genetic sequence related to type 1 diabetes susceptibility)diabetes, blood glucose, immune system response, complete blood count, and autoantibody measurements. Some family members may return for follow-up visits for up to 10 years.

Official Title
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Genetics Of Autoimmunity In Type I Diabetes

Conditions
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Type1diabetes, Diabetes Mellitus, Type 1, Type1 Diabetes Mellitus, Diabetes Mellitus

Intervention / Treatment
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* Other: Blood Collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Families): Families where at least one first-degree family member has type 1 diabetes The diabetic proband in the family was diagnosed before the age of 39 Family members must be at least 2 years old to participate Exclusion Criteria (Families): Families with no history of type 1 diabetes Families with a history of diabetes that is not type 1 (LADA, MODY, type 2 etc.) Inclusion Criteria (Controls): No family history of type 1 diabetes or other autoimmune conditions Age 2 or older Exclusion Criteria (Controls): Personal or family history of autoimmune disease

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Blood Collection|Blood will be collected via venipuncture and analyzed. Blood samples will be analyzed for HLA haplotype (a genetic sequence related to type 1 diabetes susceptibility), plasma-induced signature, diabetes autoantibodies, complete blood count with differential, and serum and plasma for storage. For family members with diabetes, blood will also be tested for A1c.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of Type 1 diabetes | The primary outcome is the development of diabetes as defined by the American Diabetes Association (ADA) based on the presence of symptoms and unequivocal hyperglycemia. | Up to 10 years | 
| Autoantibody Measurement | Presence or absence of the autoantibodies related to type 1 diabetes: IA-2 (islet antigen), GAD65 (pancreatic islet cell autoantibody), IAA (insulin autoantibody), ZnT8 (zinc transporter 8) | Up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Family, Healthy Controls, Siblings