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Genetics Of Autoimmunity In Type I Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03648918
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : October 28, 2019
Benaroya Research Institute
Indiana University
Information provided by (Responsible Party):
Martin Hessner, Medical College of Wisconsin

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
Type1diabetes Diabetes Mellitus, Type 1 Type1 Diabetes Mellitus Diabetes Mellitus 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 4000 participants
Observational Model: Family-Based
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Genetics Of Autoimmunity In Type I Diabetes
Actual Study Start Date : August 2001
Estimated Primary Completion Date : January 2050
Estimated Study Completion Date : January 2050

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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.

Primary Outcome Measures :
  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: ICA (islet cell autoantibody), IA-2A (islet antigen), GAD65A (pancreatic islet cell autoantibody), mIAA (microinsulin autoantibody), ZnT8A (zinc transporter 8)

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with T1D seen at clinics at the Children's Hospital of Wisconsin (n~1500) and Froedtert Hospital (n~800 will be targeted. In families with a child proband, siblings and parents will be asked to join the study. If the investigators find that the diabetic child has an aunt, uncle, or cousin with T1D, then that nuclear family will also be recruited. Adult proband families may include the spouse and children. Adult proband families must include children <17 years of age. If the adult proband has a sibling, niece, or nephew with T1D, 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. Singleton adult probands within 10 months of diagnosis will also be recruited.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03648918

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Contact: Martin Hessner, PhD 414-955-4903

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United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Martin Hessner, PhD    414-955-4903   
Sponsors and Collaborators
Medical College of Wisconsin
Benaroya Research Institute
Indiana University
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Principal Investigator: Martin Hessner, PhD Medical College of Wisconsin

Additional Information:

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Responsible Party: Martin Hessner, Professor, Medical College of Wisconsin Identifier: NCT03648918    
Other Study ID Numbers: 142618
McGee Family Study ( Other Identifier: Medical College of Wisconsin )
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Unidentified samples and data will be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Martin Hessner, Medical College of Wisconsin:
Healthy Controls
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Immune System Diseases