Genetics Of Autoimmunity In Type I Diabetes

Medical College of Wisconsin4,000 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

4,000

Conditions

Type1diabetes Diabetes Mellitus, Type 1 Type1 Diabetes Mellitus

Interventions

Blood CollectionOTHER

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.

Eligibility

Sex: ALLMin age: 2 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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)