Genetics Of Autoimmunity In Type I Diabetes

NCT03648918 | Recruiting

• 2 other identifiers: 142618McGee Sibling Study
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type1diabetes; Diabetes Mellitus, Type 1; Type1 Diabetes Mellitus; Diabetes Mellitus

Keywords

Family; Healthy Controls; Siblings

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

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.

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with T1D seen at clinics at the Children's Wisconsin (n\~1500) and Froedtert Hospital (n\~800) will be targeted. In families with a child proband, siblings will be asked to join the study. If the diabetic child has an aunt, uncle, or cousin with T1D, then siblings in that nuclear family will also be recruited. Adult proband families will include the adult affected by T1D and their children. Adult proband families must include children \<17 years of age. If the adult proband has a sibling, niece, or nephew with T1D, siblings in that nuclear family will be recruited as well. The age-of-diagnosis criterion for the proband will be less than 39 years and insulin therapy started within 5 years of diagnosis.

You may qualify if:

• 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

You may not qualify if:

• Families with no history of type 1 diabetes
• Families with a history of diabetes that is not type 1 (LADA, MODY, type 2 etc.)
• No family history of type 1 diabetes or other autoimmune conditions
• Age 2 or older
• Personal or family history of autoimmune disease

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Benaroya Research Institute: collaborator
• Indiana University: collaborator

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The investigators will be collecting blood samples, which will be analyzed for HLA haplotype (a genetic sequence related to type 1 diabetes susceptibility), plasma-induced signature, diabetes autoantibodies, and complete blood count with differential, as well as plasma for storage. Blood will be analyzed for A1c for participants with diabetes. Specimens will be used and stored until none is left.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Martin Hessner, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Hessner, PhD

CONTACT

414-955-4903; t1dinfo@mcw.edu

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: August 28, 2018
• Study Start: August 1, 2001
• Primary Completion (Estimated): January 1, 2050
• Study Completion (Estimated): January 1, 2050
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (1)