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NCT Number: NCT03648918

Genetics Of Autoimmunity In Type I Diabetes

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.

Recruiting

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Key information

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location status: Recruiting

Location contact

Martin Hessner, PhD

CONTACT

[email protected]

414-955-4903

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood collection

Other

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.

Primary outcomes

  1. Onset of Type 1 diabetes

    Time frame: Up to 10 years

    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.

  2. Autoantibody Measurement

    Time frame: Up to 10 years

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Hessner, PhD

CONTACT

[email protected]

414-955-4903

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Benaroya Research Institute
  • Indiana University

Registry information

Important dates

Study start
2001
Primary completion
2050
Study completion
2050
First posted
Aug 28, 2018
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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