[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT00097292":3,"trial-entities:NCT00097292":431,"trial-summary:NCT00097292":436},{"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":19,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":33,"secondary_outcomes":38,"sex":43,"minimum_age":44,"maximum_age":45,"healthy_volunteers":14,"eligibility_criteria":46,"std_ages":57,"locations":60,"central_contacts":373,"overall_officials":377,"references":382,"see_also_links":418},"NCT00097292","NHStudy (IND)","TrialNet Pathway to Prevention of T1D","RECRUITING","2030-07-31","2025-06","2025-07-01","2004-02-01","University of South Florida","OTHER",true,"Rationale:\n\nThe accrual of data from the laboratory and from epidemiologic and prevention trials has improved the understanding of the etiology and pathogenesis of type 1 diabetes mellitus (T1DM). Genetic and immunologic factors play a key role in the development of T1DM, and characterization of the early metabolic abnormalities in T1DM is steadily increasing. However, information regarding the natural history of T1DM remains incomplete. The TrialNet Natural History Study of the Development of T1DM (Pathway to Prevention Study) has been designed to clarify this picture, and in so doing, will contribute to the development and implementation of studies aimed at prevention of and early treatment in T1DM.\n\nPurpose:\n\nTrialNet is an international network dedicated to the study, prevention, and early treatment of type 1 diabetes. TrialNet sites are located throughout the United States, Canada, Finland, United Kingdom, Italy, Germany, Sweden, Australia, and New Zealand. TrialNet is dedicated to testing new approaches to the prevention of and early intervention for type 1 diabetes.\n\nThe goal of the TrialNet Natural History Study of the Development of Type 1 Diabetes is to enhance our understanding of the demographic, immunologic, and metabolic characteristics of individuals at risk for developing type 1 diabetes.\n\nThe Natural History Study will screen relatives of people with type 1 diabetes to identify those at risk for developing the disease. Relatives of people with type 1 diabetes have about a 5% percent chance of being positive for the antibodies associated with diabetes. TrialNet will identify adults and children at risk for developing diabetes by testing for the presence of these antibodies in the blood. A positive antibody test is an early indication that damage to insulin-secreting cells may have begun. If this test is positive, additional testing will be offered to determine the likelihood that a person may develop diabetes. Individuals with antibodies will be offered the opportunity for further testing to determine their risk of developing diabetes over the next 5 years and to receive close monitoring for the development of diabetes.","Detailed Description:\n\nThe Pathway to Prevention Study is conducted in two parts:\n\n* Screening\n* Monitoring (annual and semi-annual depending on risk)\n\nIn Screening , a simple blood test is done to screen for the presence of diabetes-related biochemical autoantibodies (GAD and mIAA). Additional autoantibodies ICA, IA-2A, and ZnT8A will also measured in individuals positive for mIAA. ICA, IA-2A, and ZnT8A will be measured in individuals positive for GAD. Participants can go to a TrialNet Clinical Center, Affiliate, or request a screening kit to have their blood drawn by a local physician or laboratory. Participants will be provided with their screening results within 4-6 weeks.\n\nIf autoantibodies are present, participants will be invited to have additional testing to determine their average risk of developing diabetes over the next 5 years. Participants that are single autoantibody positive will be re-tested annually for the development of multiple autoantibodies. Multiple autoantibody positive participants will undergo an eligibility visit which will include an Oral Glucose Tolerance Test (OGTT), re-testing for biochemical and islet cell autoantibodies if needed, and measurement of HbA1c.\n\nMultiple autoantibody positive individuals with a normal glucose tolerance and an HbA1c \\\u003C 6.0% will be asked to come for follow-up on annual basis; multiple autoantibody positive individuals with an abnormal glucose tolerance or an HbA1c ≥ 6.0%will be asked to come for follow-up visits on semi-annual basis.\n\nParticipants will be monitored for possible progression towards type 1 diabetes and may be offered the opportunity to enter into a prevention study such (e.g., Oral Insulin prevention study) or an early treatment study if they are diagnosed with type 1 diabetes while participating in the Natural History Study.",[18],"Diabetes Mellitus, Type 1",[20,21,22,23,24,25],"\"at risk\" for developing type 1 diabetes","T1DM","T1D","juvenile diabetes","Type 1 Diabetes TrialNet","TrialNet","OBSERVATIONAL",null,[],{"count":30,"type":31},75000,"ESTIMATED",[],[34],{"measure":35,"description":36,"timeFrame":37},"Development of type 1 diabetes","The primary outcome is the development of diabetes as defined by the American Diabetes Association (ADA) based on glucose testing, or the presence of symptoms and unequivocal hyperglycemia.","Monitoring is provided once or twice annually depending on risk level",[39],{"measure":40,"description":41,"timeFrame":42},"Metabolic and Autoantibody Assessments","Oral Glucose Tolerance Test (OGTT) HbA1c Autoantibodies: ICA, IA-2A, GAD65A, mIAA, ZnT8A","Metabolic and Autoantibody assessments are provided once or twice annually depending on risk level","ALL","2 Years","45 Years",{"inclusion":47,"exclusion":51,"raw_text":56},[48,49,50],"Individuals 2 to 45 years old who have an immediate family member with type 1 diabetes (such as a child, parent, or sibling)","Individuals 2-20 years old who have an extended family member with type 1 diabetes (such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)","Those aged 2 years to 45 years who are not family members and are known to have 1 or more islet antibodies",[52,53,54,55],"Have diabetes already","Have previous or current use of medications for the control of hyperglycemia\u002Fdiabetes.","Currently be using immunosuppressive or immunomodulatory agents (topical and inhaled agents are acceptable)","Have known severe active diseases, and\u002For diseases which are likely to limit life expectancy or lead to the use of chronic immunosuppressive or immunomodulatory therapies during the course of the study","Inclusion Criteria:\n\n* Individuals 2 to 45 years old who have an immediate family member with type 1 diabetes (such as a child, parent, or sibling)\n* Individuals 2-20 years old who have an extended family member with type 1 diabetes (such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)\n* Those aged 2 years to 45 years who are not family members and are known to have 1 or more islet antibodies\n\nExclusion Criteria:\n\nTo be eligible a person must not:\n\n* Have diabetes already\n* Have previous or current use of medications for the control of hyperglycemia\u002Fdiabetes.\n* Currently be using immunosuppressive or immunomodulatory agents (topical and inhaled agents are acceptable)\n* Have known severe active diseases, and\u002For diseases which are likely to limit life expectancy or lead to the use of chronic immunosuppressive or immunomodulatory therapies during the course of the study",[58,59],"CHILD","ADULT",[61,79,93,107,122,137,152,167,182,197,212,227,241,256,271,286,300,315,331,348,357,365],{"facility":62,"status":7,"city":63,"state":64,"zip":65,"country":66,"contacts":67,"geoPoint":76},"Childrens Hospital of Orange County","Orange","California","92868","United States",[68,73],{"name":69,"role":70,"phone":71,"email":72},"Marissa Erickson","CONTACT","714-509-8613","merickson@choc.org",{"name":74,"role":75},"Mark Daniels, MD","PRINCIPAL_INVESTIGATOR",{"lat":77,"lon":78},33.78779,-117.85311,{"facility":80,"status":7,"city":81,"state":64,"zip":82,"country":66,"contacts":83,"geoPoint":90},"University of California San Francisco","San Francisco","94143-0434",[84,88],{"name":85,"role":70,"phone":86,"email":87},"Karen Ko","844-813-8273","clinicalresearch@diabetes.ucsf.edu",{"name":89,"role":75},"Stephen Gitelman, MD",{"lat":91,"lon":92},37.77493,-122.41942,{"facility":94,"status":7,"city":95,"state":64,"zip":96,"country":66,"contacts":97,"geoPoint":104},"Stanford University Medical Center","Stanford","94305-5208",[98,102],{"name":99,"role":70,"phone":100,"email":101},"Trudy Esrey, RD","650-498-4450","tesrey@stanford.edu",{"name":103,"role":75},"Darrell Wilson, MD",{"lat":105,"lon":106},37.42411,-122.16608,{"facility":108,"status":7,"city":109,"state":110,"zip":111,"country":66,"contacts":112,"geoPoint":119},"Barbara Davis Center for Childhood Diabetes","Denver","Colorado","80262",[113,117],{"name":114,"role":70,"phone":115,"email":116},"Brenda Bradfield","303-724-8595","brenda.bradfield@CUANSCHUTZ.EDU",{"name":118,"role":75},"Andrea Steck, MD",{"lat":120,"lon":121},39.73915,-104.9847,{"facility":123,"status":7,"city":124,"state":125,"zip":126,"country":66,"contacts":127,"geoPoint":134},"Yale University School of Medicine","New Haven","Connecticut","06519",[128,132],{"name":129,"role":70,"phone":130,"email":131},"Lori Carria","203-737-3595","lori.carria@yale.edu",{"name":133,"role":75},"Jennifer Sherr, MD",{"lat":135,"lon":136},41.30815,-72.92816,{"facility":138,"status":7,"city":139,"state":140,"zip":141,"country":66,"contacts":142,"geoPoint":149},"University of Florida","Gainesville","Florida","32601-0296",[143,147],{"name":144,"role":70,"phone":145,"email":146},"Jennifer Hosford","352-294-5759","jennifer.hosford@peds.ufl.edu",{"name":148,"role":75},"Michael Haller, MD",{"lat":150,"lon":151},29.65163,-82.32483,{"facility":153,"status":7,"city":154,"state":155,"zip":156,"country":66,"contacts":157,"geoPoint":164},"Emory Children's Center","Atlanta","Georgia","30322",[158,162],{"name":159,"role":70,"phone":160,"email":161},"Xiaomiao Lan-Pidhainy, RN","404-712-0051","xlanpid@emory.edu",{"name":163,"role":75},"Andrew Muir, MD",{"lat":165,"lon":166},33.749,-84.38798,{"facility":168,"status":7,"city":169,"state":170,"zip":171,"country":66,"contacts":172,"geoPoint":179},"Riley Hospital for Children, Indiana University","Indianapolis","Indiana","46202",[173,177],{"name":174,"role":70,"phone":175,"email":176},"Maria Spall","866-230-8486","malnicho@iu.edu",{"name":178,"role":75},"Linda DeMeglio, MD",{"lat":180,"lon":181},39.76838,-86.15804,{"facility":183,"status":7,"city":184,"state":185,"zip":186,"country":66,"contacts":187,"geoPoint":194},"Joslin Diabetes Center","Boston","Massachusetts","02215",[188,192],{"name":189,"role":70,"phone":190,"email":191},"Nora Bryant","617-309-4141","nora.bryant@joslin.harvard.edu",{"name":193,"role":75},"Jason Gaglia, MD",{"lat":195,"lon":196},42.35843,-71.05977,{"facility":198,"status":7,"city":199,"state":200,"zip":201,"country":66,"contacts":202,"geoPoint":209},"University of Minnesota","Minneapolis","Minnesota","58944",[203,207],{"name":204,"role":70,"phone":205,"email":206},"Beth Pappenfus","612-624-2922","papp0086@umn.edu",{"name":208,"role":75},"Antoinette Moran, MD",{"lat":210,"lon":211},44.97997,-93.26384,{"facility":213,"status":7,"city":214,"state":215,"zip":216,"country":66,"contacts":217,"geoPoint":224},"The Children's Mercy Hospital","Kansas City","Missouri","64111",[218,222],{"name":219,"role":70,"phone":220,"email":221},"Cassandra McClain","816-960-8877","clmcclain@cmh.edu",{"name":223,"role":75},"Wayne Moore, Md, PhD",{"lat":225,"lon":226},39.09973,-94.57857,{"facility":228,"status":7,"city":229,"state":229,"zip":230,"country":66,"contacts":231,"geoPoint":238},"Columbia University","New York","10032",[232,236],{"name":233,"role":70,"phone":234,"email":235},"Jamie R Hyatt","212-851-5425","jh4470@cumc.columbia.edu",{"name":237,"role":75},"Robin S Goland, MD",{"lat":239,"lon":240},40.71427,-74.00597,{"facility":242,"status":7,"city":243,"state":244,"zip":245,"country":66,"contacts":246,"geoPoint":253},"Children's Hospital of Pittsburgh of UPMC","Pittsburgh","Pennsylvania","15213",[247,251],{"name":248,"role":70,"phone":249,"email":250},"Kelli DeLallo, RN","412-692-5210","kelli.delallo@chp.edu",{"name":252,"role":75},"Dorothy Becker, MD",{"lat":254,"lon":255},40.44062,-79.99589,{"facility":257,"status":7,"city":258,"state":259,"zip":260,"country":66,"contacts":261,"geoPoint":268},"Vanderbilt University","Nashville","Tennessee","37232",[262,266],{"name":263,"role":70,"phone":264,"email":265},"Faith Brendle, RN","615-936-8638","faith.brendle@vanderbilt.edu",{"name":267,"role":75},"William Russell, MD",{"lat":269,"lon":270},36.16589,-86.78444,{"facility":272,"status":7,"city":273,"state":274,"zip":275,"country":66,"contacts":276,"geoPoint":283},"University of Texas Medical Center at Dallas","Dallas","Texas","75390-8858",[277,281],{"name":278,"role":70,"phone":279,"email":280},"Lindsay Harter","214-648-4725","Lindsay.Harter@UTSouthwestern.edu",{"name":282,"role":75},"Perrin White, MD",{"lat":284,"lon":285},32.78306,-96.80667,{"facility":287,"status":7,"city":288,"state":274,"zip":289,"country":66,"contacts":290,"geoPoint":297},"Baylor College of Medicine","Houston","77030",[291,295],{"name":292,"role":70,"phone":293,"email":294},"Sandra Pena","832-822-3380","sypena@texaschildrens.org",{"name":296,"role":75},"Maria Redondo, MD",{"lat":298,"lon":299},29.76328,-95.36327,{"facility":301,"status":7,"city":302,"state":303,"zip":304,"country":66,"contacts":305,"geoPoint":312},"Benaroya Research Institute","Seattle","Washington","98101-2795",[306,310],{"name":307,"role":70,"phone":308,"email":309},"Katie Bennett","206-341-8945","diabetes@benaroyaresearch.org",{"name":311,"role":75},"Carla Greenbaum, MD",{"lat":313,"lon":314},47.60621,-122.33207,{"facility":316,"status":7,"city":317,"state":318,"zip":319,"country":320,"contacts":321,"geoPoint":328},"Walter and Eliza Hall Institute","Parkville","Victoria","3050","Australia",[322,326],{"name":323,"role":70,"phone":324,"email":325},"Felicity Healy","61-3-9342 7063","felicity.healy@mh.org.au",{"name":327,"role":75},"Peter C Colman, MD",{"lat":329,"lon":330},-37.78333,144.95,{"facility":332,"status":7,"city":333,"state":334,"zip":335,"country":336,"contacts":337,"geoPoint":345},"The Hospital for Sick Children","Toronto","Ontario","M5G-1x8","Canada",[338,343],{"name":339,"role":70,"phone":340,"phoneExt":341,"email":342},"Rebecca Stochinsky","(416) 813-7654","202634","rebecca.stochinsky@sickkids.ca",{"name":344,"role":75},"Diane Wherrett, MD",{"lat":346,"lon":347},43.70643,-79.39864,{"facility":349,"status":350,"city":351,"zip":352,"country":353,"geoPoint":354},"University of Turku","SUSPENDED","Turku","FIN-20520","Finland",{"lat":355,"lon":356},60.45148,22.26869,{"facility":358,"status":350,"city":359,"zip":360,"country":361,"geoPoint":362},"Vita-Salute San Raffaele University","Milan","+39-02-2643 2818","Italy",{"lat":363,"lon":364},45.46427,9.18951,{"facility":366,"status":350,"city":367,"zip":368,"country":369,"geoPoint":370},"University of Bristol","Bristol","BS10 5NB UK","United Kingdom",{"lat":371,"lon":372},51.45523,-2.59665,[374],{"name":375,"role":70,"phone":376},"TrialNet Central Information Center general info","1-800-425-8361",[378],{"name":379,"affiliation":380,"role":381},"Kevan Herold, M.D.","Yale University","STUDY_CHAIR",[383,387,390,393,396,399,403,406,409,412,415],{"pmid":384,"type":385,"citation":386},"12037147","BACKGROUND","Diabetes Prevention Trial--Type 1 Diabetes Study Group. Effects of insulin in relatives of patients with type 1 diabetes mellitus. N Engl J Med. 2002 May 30;346(22):1685-91. doi: 10.1056\u002FNEJMoa012350.",{"pmid":388,"type":385,"citation":389},"15043959","Gale EA, Bingley PJ, Emmett CL, Collier T; European Nicotinamide Diabetes Intervention Trial (ENDIT) Group. European Nicotinamide Diabetes Intervention Trial (ENDIT): a randomised controlled trial of intervention before the onset of type 1 diabetes. Lancet. 2004 Mar 20;363(9413):925-31. doi: 10.1016\u002FS0140-6736(04)15786-3.",{"pmid":391,"type":385,"citation":392},"11476858","Atkinson MA, Eisenbarth GS. Type 1 diabetes: new perspectives on disease pathogenesis and treatment. Lancet. 2001 Jul 21;358(9277):221-9. doi: 10.1016\u002FS0140-6736(01)05415-0.",{"pmid":394,"type":385,"citation":395},"8666144","Verge CF, Gianani R, Kawasaki E, Yu L, Pietropaolo M, Jackson RA, Chase HP, Eisenbarth GS. Prediction of type I diabetes in first-degree relatives using a combination of insulin, GAD, and ICA512bdc\u002FIA-2 autoantibodies. Diabetes. 1996 Jul;45(7):926-33. doi: 10.2337\u002Fdiab.45.7.926.",{"pmid":397,"type":385,"citation":398},"7926304","Bingley PJ, Christie MR, Bonifacio E, Bonfanti R, Shattock M, Fonte MT, Bottazzo GF, Gale EA. Combined analysis of autoantibodies improves prediction of IDDM in islet cell antibody-positive relatives. Diabetes. 1994 Nov;43(11):1304-10. doi: 10.2337\u002Fdiab.43.11.1304.",{"pmid":400,"type":401,"citation":402},"40439773","DERIVED","Martinenghi S, Merolla A, Grogan P, Bianconi E, Senni E, Goncharova A, Massara F, Ragogna F, Bazzigaluppi E, Pastore MR, Bonfanti R, Bosi E. Prevention of diabetic ketoacidosis in relatives screened for islet autoantibodies and followed up in the TrialNet Pathway to Prevention study at a single institution in Italy. Diabetologia. 2025 Sep;68(9):1889-1898. doi: 10.1007\u002Fs00125-025-06461-z. Epub 2025 May 29.",{"pmid":404,"type":401,"citation":405},"34850014","Triolo TM, Pyle L, Broncucia H, Armstrong T, Yu L, Gottlieb PA, Steck AK. Association of High-Affinity Autoantibodies With Type 1 Diabetes High-Risk HLA Haplotypes. J Clin Endocrinol Metab. 2022 Mar 24;107(4):e1510-e1517. doi: 10.1210\u002Fclinem\u002Fdgab853.",{"pmid":407,"type":401,"citation":408},"30089716","Evans-Molina C, Sims EK, DiMeglio LA, Ismail HM, Steck AK, Palmer JP, Krischer JP, Geyer S, Xu P, Sosenko JM; Type 1 Diabetes TrialNet Study Group. beta Cell dysfunction exists more than 5 years before type 1 diabetes diagnosis. JCI Insight. 2018 Aug 9;3(15):e120877. doi: 10.1172\u002Fjci.insight.120877. eCollection 2018 Aug 9.",{"pmid":410,"type":401,"citation":411},"29092051","Ferrara CT, Geyer SM, Evans-Molina C, Libman IM, Becker DJ, Wentworth JM, Moran A, Gitelman SE, Redondo MJ; Type 1 Diabetes TrialNet Study Group. The Role of Age and Excess Body Mass Index in Progression to Type 1 Diabetes in At-Risk Adults. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4596-4603. doi: 10.1210\u002Fjc.2017-01490.",{"pmid":413,"type":401,"citation":414},"28531305","Bosi E, Boulware DC, Becker DJ, Buckner JH, Geyer S, Gottlieb PA, Henderson C, Kinderman A, Sosenko JM, Steck AK, Bingley PJ; Type 1 Diabetes TrialNet Study Group. Impact of Age and Antibody Type on Progression From Single to Multiple Autoantibodies in Type 1 Diabetes Relatives. J Clin Endocrinol Metab. 2017 Aug 1;102(8):2881-2886. doi: 10.1210\u002Fjc.2017-00569.",{"pmid":416,"type":401,"citation":417},"25642774","Herold KC, Usmani-Brown S, Ghazi T, Lebastchi J, Beam CA, Bellin MD, Ledizet M, Sosenko JM, Krischer JP, Palmer JP; Type 1 Diabetes TrialNet Study Group. beta cell death and dysfunction during type 1 diabetes development in at-risk individuals. J Clin Invest. 2015 Mar 2;125(3):1163-73. doi: 10.1172\u002FJCI78142. Epub 2015 Feb 2.",[419,422,425,428],{"label":420,"url":421},"TrialNet Study Group","http:\u002F\u002Fwww.diabetestrialnet.org",{"label":423,"url":424},"Type 1 Diabetes Clinical Trials","https:\u002F\u002Fwww.niddk.nih.gov\u002Fabout-niddk\u002Fresearch-areas\u002Fdiabetes\u002Ftype-1-diabetes-special-statutory-funding-program\u002Fspecial-diabetes-program-clinical-trials-recruiting-patients-families",{"label":426,"url":427},"American Diabetes Association","http:\u002F\u002Fwww.diabetes.org",{"label":429,"url":430},"Juvenile Diabetes Research Foundation International","http:\u002F\u002Fwww.jdrf.org",{"nct_id":4,"conditions":432,"biomarkers":434},[433],"Type 1 Diabetes Mellitus",[435],"Islet antibodies",{"nct_id":4,"found":14,"summary":437,"prompt_version":447},{"design":438,"status":439,"heading":440,"summary":441,"follow_up":442,"word_count":443,"commitments":444,"compensation":445,"drugs_mentioned":446},"This is an observational study with a planned enrollment of 75,000 participants. It involves screening and ongoing monitoring.","completed","TrialNet Pathway to Prevention of Type 1 Diabetes","This observational study, called the Pathway to Prevention, is looking to better understand how Type 1 Diabetes (T1D) develops. There are no specific interventions or treatments being tested. Instead, researchers are studying people who are at higher risk for T1D to learn more about the disease's natural progression. The main goal is to see who develops T1D over time. You might be able to join if you are between 2 and 45 years old and have a close family member with T1D, or if you are 2-20 years old and have an extended family member with T1D. This study aims to gather information that can help develop future prevention and early treatment strategies for T1D.","Monitoring for the development of type 1 diabetes is provided once or twice annually depending on risk level.",115,"You would undergo a simple blood test for screening. If autoantibodies are present, you may have additional testing, including an Oral Glucose Tolerance Test (OGTT) and HbA1c measurement. Monitoring is provided once or twice annually depending on your risk level.","Not stated in the trial record.",[],"v2"]