Diabetes Mellitus Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 4000 |
Est. completion date | January 2050 |
Est. primary completion date | January 2050 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Medical College of Wisconsin | Benaroya Research Institute, Indiana University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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