Genetics Of Autoimmunity In Type I Diabetes
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|ClinicalTrials.gov Identifier: NCT03648918|
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : October 28, 2019
|Condition or disease||Intervention/treatment|
|Type1diabetes Diabetes Mellitus, Type 1 Type1 Diabetes Mellitus Diabetes Mellitus||Other: Blood Collection|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||4000 participants|
|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|
- 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.
- 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.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT03648918
|Contact: Martin Hessner, PhDfirstname.lastname@example.org|
|United States, Wisconsin|
|Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Martin Hessner, PhD 414-955-4903 email@example.com|
|Principal Investigator:||Martin Hessner, PhD||Medical College of Wisconsin|