Genetics Of Autoimmunity In Type I Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorMedical College of Wisconsin
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Family-based
Time perspective
Prospective
Treatments tested in this trial
Blood Collection
Other interventionBlood 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 10 years2
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)
Time frame
Up to 10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical College of Wisconsin
Lead sponsor
Benaroya Research Institute
Collaborator
Indiana University
Collaborator
Source ClinicalTrials.gov