NCT03648918

Genetics Of Autoimmunity In Type I Diabetes

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Type1diabetes
• Diabetes Mellitus, Type 1
• Type1 Diabetes Mellitus
• Diabetes Mellitus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2001-08-01
• Primary completion: 2050-01-01
• Completion: 2050-01-01
• First posted: 2018-08-28
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States