[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657288":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":27,"studyPopulation":28,"armGroups":29,"interventions":23,"overallOfficials":23,"centralContacts":39,"locations":45,"responsibleParty":64,"collaborators":23,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":23,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":23,"studyType":80,"phases":23,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":48,"whyStopped":23,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Second Xiangya Hospital of Central South University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":23},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change From Baseline in Fasting C-peptide Concentration at 1 Year","Fasting C-peptide concentration will be measured at baseline and at 1 year after enrollment. The change from baseline will be calculated as the C-peptide concentration at 1 year minus the baseline concentration and reported in pmol\u002FL.","Baseline to 1 year after enrollment",{"measure":14,"description":15,"timeFrame":12},"Change From Baseline in 2-Hour Postprandial C-peptide Concentration at 1 Year","Two-hour postprandial C-peptide concentration will be measured at baseline and at 1 year after enrollment. The change from baseline will be calculated as the 2-hour postprandial C-peptide concentration at 1 year minus the baseline concentration and reported in pmol\u002FL.",[17,20],{"measure":18,"description":19,"timeFrame":12},"Serum Islet Autoantibodies seroconversion.","Serum islet autoantibodies, including glutamic acid decarboxylase autoantibody (GADA), insulinoma-associated protein 2 autoantibody (IA-2A), zinc transporter 8 autoantibody (ZnT8A), and insulin autoantibody (IAA), will be measured at baseline and 1 year after enrollment.",{"measure":21,"description":22,"timeFrame":12},"Change From Baseline in Number of Positive Serum Islet Autoantibodies at 1 Year","Serum islet autoantibodies, including glutamic acid decarboxylase autoantibody (GADA), insulinoma-associated protein 2 autoantibody (IA-2A), zinc transporter 8 autoantibody (ZnT8A), and insulin autoantibody (IAA), will be measured at baseline and 1 year after enrollment. The number of positive islet autoantibodies will be recorded at each time point, and the change from baseline will be calculated as the number at 1 year minus the number at baseline.",null,{"allocation":23,"interventionModel":23,"interventionModelDescription":23,"primaryPurpose":23,"observationalModel":25,"timePerspective":26,"maskingInfo":23},"COHORT","PROSPECTIVE","Type 1 diabetes (T1D) is a hyperglycemic disease caused by absolute insulin deficiency. It has an acute and early onset, and patients require lifelong insulin therapy. Global T1D incidence is rising yearly. China has the fourth-largest number of T1D patients and the second-fastest increase in incidence, with a marked rise in adults. T1D results from genetic and environmental factors that cause immune destruction of pancreatic β cells. Genetic risk is relatively clear: HLA DR4-DQ8 and DR3-DQ2 carry the highest risk, and over 70 related loci have been identified. However, environmental factors remain insufficiently characterized. Studies of migrants, socioeconomic differences, and mobile populations suggest that environment and lifestyle have significant effects. Since China's genetic background has not changed substantially while incidence continues to rise, environment-induced immune dysregulation combined with genetic susceptibility may be key. International cohorts such as TEDDY and DAISY confirm that diet, viral infections, and gut microbiota can trigger islet autoimmunity. Among specific factors, high maternal early-pregnancy BMI, rapid childhood growth, and obesity increase risk; vitamin D is protective, and China's north-high\u002Fsouth-low incidence gradient may relate to sunlight and vitamin D. Gluten may trigger islet autoimmune inflammation via gut microbiota and immune activation. Viral infection, pollution, chemical exposure, and socioeconomic status may also contribute. Most evidence comes from European and American populations, while Chinese studies are limited. Therefore, systematically identifying China-specific environmental risk factors has important scientific and public-health value. In summary, genetics determines susceptibility, while modifiable environmental factors are critical in triggering and progression and are key to early prevention and precision management of T1D.","Individuals with type 1 diabetes, first-degree relatives of individuals with type 1 diabetes, and controls recruited from 18 provinces in China.",[30,33,36],{"label":31,"type":23,"description":32,"interventionNames":23},"Controls","Controls matched to the recruited patients.",{"label":34,"type":23,"description":35,"interventionNames":23},"FDR","First-degree relatives of patients with type 1 diabetes.",{"label":37,"type":23,"description":38,"interventionNames":23},"T1D","patients with type 1 diabetes",[40],{"name":41,"role":42,"phone":43,"phoneExt":23,"email":44},"Yang Xiao","CONTACT","86-731-85292154","xiaoyang29@csu.edu.cn",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"the Second Xiangya Hospital, central south of university","RECRUITING","Changsha","Hunan","410011","China","CN",{"type":55,"coordinates":56},"Point",[57,58],112.97087,28.19874,{"lat":58,"lon":57},[61],{"name":62,"role":42,"phone":63,"phoneExt":23,"email":44},"Yang Xiao, MD\u002FPhd","13574848588",{"type":65,"investigatorFullName":41,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Professor; Chief Physician; Vice President, Second Xiangya Hospital of Central South University; Deputy Director, National Clinical Research Center for Endocrine and metabolic Diseases;","100657288","environmental-determinants-of-type-1-diabetes-risk-100657288",false,"NCT07835724","Environmental Determinants of Type 1 Diabetes Risk","Inclusion Criteria:\n\n1. Individuals with type 1 diabetes (no age restriction):\n\n   * Clinically diagnosed with T1D by a specialist.\n   * Meeting any one of the following conditions:(1) Age of onset \\\u003C 15 years;(2) No overweight or obesity at onset;(3) History of ketoacidosis.\n   * Insulin-dependent since disease onset;\n   * Positive for at least one islet autoantibody (GADA, IA-2A, ZnT8A, IAA, ICA);\n   * Disease duration ≤ 3 years.\n2. First-degree relatives:\n\n   * Parents, siblings, or children of an individual with T1D.\n   * Age ≤ 45 years.\n\nExclusion Criteria:\n\n1. Individuals with type 1 diabetes\n\n   * Gestational diabetes.\n   * Confirmed monogenic diabetes.\n   * Secondary diabetes.\n   * Type 2 diabetes.\n   * Other specific types of diabetes.\n2. First-degree relatives:\n\n   * Diagnosed with diabetes before screening;\n   * Previous or current use of glucose-lowering drugs.\n\nCommon exclusion criteria:\n\n* Severe active disease or a condition likely to substantially affect life expectancy, including malignancy or severe cardiac, pulmonary, hepatic, or renal disease.\n* A condition that may require immunosuppressive therapy during the study period.\n* Current systemic immunosuppressive therapy.\n* Current systemic glucocorticoid therapy.\n* Participation in another drug or medical device trial during recruitment or the study period.\n* History of major surgery or severe trauma.",true,"ALL","3 Years","70 Years",{"count":78,"type":79},11240,"ESTIMATED","OBSERVATIONAL","To analyze the environmental risk factors for type 1 diabetes in China.",[83,84,85],"Type 1 Diabetes Mellitus (T1DM)","Healthy Control","Relatives to\u002FCarers of Patients",[87,88],"type 1 diabetes","environmental factors","2026-09-22",{"date":91,"type":92},"2026-09-23","ACTUAL",{"date":94,"type":92},"2024-08-01",{"date":96,"type":79},"2030-08-01",{"name":5,"class":6},1]