[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05899439":3,"trial-entities:NCT05899439":112,"trial-summary:NCT05899439":116},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":41,"sex":42,"minimum_age":43,"maximum_age":44,"healthy_volunteers":45,"eligibility_criteria":46,"std_ages":50,"locations":54,"central_contacts":102,"overall_officials":109,"references":110,"see_also_links":111},"NCT05899439","IRB201400709","Immune Function and the Progression to T1D","Immune Function and the Progression to Type 1 Diabetes:","RECRUITING","2085-01-01","2026-04","2026-04-09","2005-01-01","University of Florida","OTHER",false,"To elucidate the mechanisms by which type 1 diabetes-associated genes; IFIH1, TYK2, IKZF4, as well as total genetic risk, impart functional immunoregulatory abnormalities that result in expansion of self-reactive adaptive immune cells, defective regulatory\u002Feffector mechanisms in T cells, inflammatory antigen presenting cells, and abnormal immune function in T cells and B cells.","Newly proposed studies will identify the inflammatory cues that draw immune cells into islets for disease initiation (Project 1); probe the motility of immune cells through inflamed vasculature to the target organ and antigen priming sites within secondary lymphatics (Project 2); and characterize the T1D-associated adaptive immune signatures in blood and immune tissues (Project 3).\n\nThe overall hypothesis of the renewed P01 states: 1) the impact of T1D-risk variants will vary by tissue, cell subset, and activation state, and 2) risk variants, cellular stress, and defects in immunologic pathways are key to engender the autoimmune destruction of pancreatic B-cells that results in T1D.",[19],"Type 1 Diabetes",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},2800,"ESTIMATED",[28],{"type":14,"name":29,"description":30,"armGroupLabels":31},"blood draw","a peripheral blood draw",[32,33],"Subjects with diabetes age 0 to 100 years","Subjects with type 1 diabetes age 0 to 100 years",[35,38],{"measure":36,"description":36,"timeFrame":37},"the number of participants who become at risk for development of type 1 diabetes","through study completion, up to 25 years",{"measure":39,"description":40,"timeFrame":37},"Genetic risk of type 1 diabetes","the number of people in different genetic risk groups who develop type 1 diabetes",[],"ALL","0 Years","100 Years",true,{"inclusion":47,"exclusion":48,"raw_text":49},[],[],"Inclusion Criteria: able to have blood drawn -\n\nExclusion Criteria: none\n\n\\-",[51,52,53],"CHILD","ADULT","OLDER_ADULT",[55,72,85],{"facility":56,"status":8,"city":57,"state":58,"zip":59,"country":60,"contacts":61,"geoPoint":69},"Kieran McGrail","Gainesville","Florida","32610","United States",[62,66],{"name":56,"role":63,"phone":64,"email":65},"CONTACT","352-273-9299","mcgrail@pathology.ufl.edu",{"name":67,"role":68},"Todd Brusko, PhD","PRINCIPAL_INVESTIGATOR",{"lat":70,"lon":71},29.65163,-82.32483,{"facility":73,"status":8,"city":74,"state":75,"zip":76,"country":60,"contacts":77,"geoPoint":82},"The Ohio State University","Columbus","Ohio","43210",[78],{"name":79,"role":63,"phone":80,"email":81},"Billur Akkaya, MD DPhil","614-688-1187","billur.akkaya@osumc.edu",{"lat":83,"lon":84},39.96118,-82.99879,{"facility":86,"status":8,"city":87,"state":88,"zip":89,"country":60,"contacts":90,"geoPoint":99},"Baylor College of Medicine, Center for Research Advancement - Texas Children's Hospital","Houston","Texas","77030",[91,95],{"name":92,"role":63,"phone":93,"email":94},"Maria Redondo, MD, PhD, MPH","832-822-1019","redondo@bcm.edu",{"name":96,"role":63,"phone":97,"email":98},"Franca Erhiawarie","832-824-3372","Franca.Ofudu@bcm.edu",{"lat":100,"lon":101},29.76328,-95.36327,[103,107],{"name":104,"role":63,"phone":105,"email":106},"Jennifer L Hosford, MPH","352-294-5759","jennifer.hosford@peds.ufl.edu",{"name":56,"role":63,"phone":108,"email":65},"(352) 273-9299",[],[],[],{"nct_id":4,"conditions":113,"biomarkers":115},[114],"Type 1 Diabetes Mellitus",[],{"nct_id":4,"found":45,"summary":117,"prompt_version":127},{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This is an observational study, meaning researchers will observe participants without providing any specific treatment. It plans to enroll 2800 participants.","completed","Understanding Immune Function and Type 1 Diabetes Progression","This observational study aims to understand how certain genes related to type 1 diabetes (T1D) affect your immune system and lead to the development of T1D. Researchers are looking at genes like IFIH1, TYK2, and IKZF4, as well as your overall genetic risk. They want to see how these genes might cause immune cells to become self-reactive, meaning they mistakenly attack your own body, and how they affect the function of different immune cells (T cells and B cells). The study will involve a blood draw to collect samples. The main goals are to count how many participants become at risk for T1D and to assess their genetic risk for T1D, with measurements taken throughout the study, which could last up to 25 years. This study is currently unclear on its recruitment status and is open to people of all genders, aged 0 to 100 years, who are able to have blood drawn.","Participants will be followed for up to 25 years to measure the number who become at risk for type 1 diabetes and their genetic risk.",153,"Participants will undergo a peripheral blood draw. The study duration for measuring primary outcomes can be up to 25 years.","Not stated in the trial record.",[29],"v2"]