[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03648918":3,"trial-entities:NCT03648918":86,"trial-summary:NCT03648918":90},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":22,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":36,"secondary_outcomes":44,"sex":45,"minimum_age":46,"maximum_age":27,"healthy_volunteers":47,"eligibility_criteria":48,"std_ages":60,"locations":64,"central_contacts":79,"overall_officials":81,"references":84,"see_also_links":85},"NCT03648918","142618","Genetics Of Autoimmunity In Type I Diabetes","RECRUITING","2050-01","2026-03","2026-03-16","2001-08","Medical College of Wisconsin","OTHER",false,"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.","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.\n\nParticipants 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.",[18,19,20,21],"Type1diabetes","Diabetes Mellitus, Type 1","Type1 Diabetes Mellitus","Diabetes Mellitus",[23,24,25],"Family","Healthy Controls","Siblings","OBSERVATIONAL",null,[],{"count":30,"type":31},4000,"ESTIMATED",[33],{"type":13,"name":34,"description":35},"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.",[37,41],{"measure":38,"description":39,"timeFrame":40},"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",{"measure":42,"description":43,"timeFrame":40},"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)",[],"ALL","2 Years",true,{"inclusion":49,"exclusion":55,"raw_text":59},[50,51,52,53,54],"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","No family history of type 1 diabetes or other autoimmune conditions","Age 2 or older",[56,57,58],"Families with no history of type 1 diabetes","Families with a history of diabetes that is not type 1 (LADA, MODY, type 2 etc.)","Personal or family history of autoimmune disease","Inclusion Criteria (Families):\n\n* Families where at least one first-degree family member has type 1 diabetes\n* The diabetic proband in the family was diagnosed before the age of 39\n* Family members must be at least 2 years old to participate\n\nExclusion Criteria (Families):\n\n* Families with no history of type 1 diabetes\n* Families with a history of diabetes that is not type 1 (LADA, MODY, type 2 etc.)\n\nInclusion Criteria (Controls):\n\n* No family history of type 1 diabetes or other autoimmune conditions\n* Age 2 or older\n\nExclusion Criteria (Controls):\n\n* Personal or family history of autoimmune disease",[61,62,63],"CHILD","ADULT","OLDER_ADULT",[65],{"facility":12,"status":7,"city":66,"state":67,"zip":68,"country":69,"contacts":70,"geoPoint":76},"Milwaukee","Wisconsin","53226","United States",[71],{"name":72,"role":73,"phone":74,"email":75},"Martin Hessner, PhD","CONTACT","414-955-4903","t1dinfo@mcw.edu",{"lat":77,"lon":78},43.0389,-87.90647,[80],{"name":72,"role":73,"phone":74,"email":75},[82],{"name":72,"affiliation":12,"role":83},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":87,"biomarkers":89},[88],"Type 1 Diabetes Mellitus",[],{"nct_id":4,"found":47,"summary":91,"prompt_version":101},{"design":92,"status":93,"heading":94,"summary":95,"follow_up":96,"word_count":97,"commitments":98,"compensation":99,"drugs_mentioned":100},"This is an observational study planning to enroll 4000 participants. It involves families where at least one member has Type 1 diabetes.","completed","Genetics of Autoimmunity in Type 1 Diabetes Study","This study aims to understand how Type 1 diabetes develops by looking at genetic and environmental factors that affect the immune system. Researchers will collect blood samples to analyze your genes (HLA haplotype, a genetic sequence related to type 1 diabetes susceptibility), immune system responses, and other blood markers. They hope to learn more about the step-by-step process that leads to Type 1 diabetes. You may be eligible if you have a first-degree family member (like a parent, sibling, or child) with Type 1 diabetes who was diagnosed before age 39, and you are at least 2 years old. The study will track the onset of Type 1 diabetes and changes in autoantibodies (markers of immune system activity) for up to 10 years.","Some participants will be followed for up to 10 years to monitor for the onset of Type 1 diabetes and changes in autoantibodies.",123,"You will have a blood draw, a brief medical history questionnaire, and measurements of your height and weight. Some participants may have annual follow-up visits for up to 10 years.","Not stated in the trial record.",[],"v2"]