Genetics Of Autoimmunity In Type I Diabetes

Sponsor
Medical College of Wisconsin (Other)
Overall Status
Recruiting
CT.gov ID
NCT03648918
Collaborator
Benaroya Research Institute (Other), Indiana University (Other)
4,000
1
581
6.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood Collection

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
4000 participants
Observational Model:
Family-Based
Time Perspective:
Prospective
Official Title:
Genetics Of Autoimmunity In Type I Diabetes
Actual Study Start Date :
Aug 1, 2001
Anticipated Primary Completion Date :
Jan 1, 2050
Anticipated Study Completion Date :
Jan 1, 2050

Outcome Measures

Primary Outcome Measures

  1. Onset of Type 1 diabetes [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

Sponsors and Collaborators

  • Medical College of Wisconsin
  • Benaroya Research Institute
  • Indiana University

Investigators

  • Principal Investigator: Martin Hessner, PhD, Medical College of Wisconsin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Martin Hessner, Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT03648918
Other Study ID Numbers:
  • 142618
  • McGee Sibling Study
First Posted:
Aug 28, 2018
Last Update Posted:
Nov 30, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Martin Hessner, Professor, Medical College of Wisconsin
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 30, 2021