[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autoimmune-diabetes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autoimmune-diabetes":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,81,123],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100637548","phase-1-sequential-immune-modulation-and-antigen-specific-tolerance-induction-for-disease-modification-in-recent-onset-type-1-diabetes-100637548",false,"NCT07610213","Sequential Immune Modulation and Antigen-Specific Tolerance Induction for Disease Modification in Recent-Onset Type 1 Diabetes","MATIN-2: Sequential Immune Modulation and Antigen-Specific Tolerance Induction for Disease Modification in Recent-Onset Type 1 Diabetes - A Mechanistic Framework and Phase I\u002FII Protocol Proposal","MATIN-2","Inclusion Criteria:\n\n* Age 18-45 years\n* Clinical diagnosis of Type 1 diabetes mellitus within 6 months of enrolment\n* Positive for at least one diabetes-related autoantibody (GAD65, IA-2, ZnT8, or IAA)\n* Detectable fasting or stimulated C-peptide ≥ 0.2 nmol\u002FL\n* HbA1c ≤ 10% (86 mmol\u002Fmol)\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Prior immunosuppressive therapy within 3 months\n* Active or chronic infection (HIV, hepatitis B\u002FC, tuberculosis)\n* Current or prior malignancy within 5 years (except non-melanoma skin cancer)\n* Pregnancy or breastfeeding\n* Severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²)\n* Severe hepatic impairment (Child-Pugh C)\n* Known hypersensitivity to teplizumab or any excipient\n* Participation in another interventional trial within 30 days\n* Current systemic corticosteroid or immunomodulatory agent use\n* History of other autoimmune disease requiring immunosuppression\n* Absolute lymphocyte count \\\u003C 1.0 × 10⁹\u002FL\n* ALT or AST \\> 3× upper limit of normal\n* Haemoglobin \\\u003C 100 g\u002FL\n* Unwillingness to use contraception during study period","ALL","18 Years","45 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study tests a three-phase immune treatment for people recently diagnosed with Type 1 diabetes (within 6 months, with some insulin production remaining).\n\nPhase 1 (weeks 1-2): Teplizumab, an anti-CD3 antibody, is given by infusion to slow immune attack on insulin-producing beta cells.\n\nPhase 2 (months 2-9): Insulin is injected directly into a lymph node (intralymphatic immunotherapy, ILIT) alongside low-dose interleukin-2 to teach the immune system to tolerate insulin and expand protective regulatory T cells.\n\nPhase 3 (months 10-24): Low-dose interleukin-2 is continued to maintain immune tolerance.\n\nThe main goal is to preserve the body's remaining insulin production (measured by C-peptide). Sixty adults aged 18-45 will be randomly assigned to the MATIN-2 protocol or standard care. Safety, immune markers, and HbA1c will also be monitored.",[28,29,30],"Type 1 Diabetes Mellitus (T1DM)","Type 1 Diabetes Mellitus","Autoimmune Diabetes",[32,33,34,35,36,37],"teplizumab","intralymphatic immunotherapy","regulatory T cells","immune tolerance","C-peptide","beta cell preservation","NOT_YET_RECRUITING","2026-05-20",{"date":41,"type":42},"2026-05-27","ACTUAL",{"date":44,"type":22},"2027-01-01",{"date":46,"type":22},"2030-06-01",{"name":48,"class":49},"Abdullah Kars","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":50},"100567625","intensive-dietary-and-activity-counselling-idac-100567625","NCT06670625","Intensive Dietary and Activity Counselling (IDAC)","Intensive Dietary and Activity Counselling","IDAC","Inclusion Criteria:\n\n* The age of the infant at time of enrolment should be 3.0 months (13 - 17 weeks).\n* An increased genetic risk (7-10%) to develop beta-cell autoantibodies by the age of 6 years.\n\nGenetic inclusion criteria: Children without a T1D-FDR having HLA DR3\u002FDR4-DQ8, DR4-DQ8\u002FDR4-DQ8 or DR4-DQ8\u002FDR4-DQ7 rs6901541 C\u002FT genotype and:\n\n* for males having a genetic risk score greater than or equal to 18.2 but excluding those who are eligible for AVANT1A.\n* for females having a genetic risk score greater than or equal to 14.5 but excluding those who are eligible for AVANT1A.\n\nChildren with a T1D-FDR, all DR3\u002F3, DR4-DQ8\u002FDR4-DQ7 and DR4-DQ8\u002Fx where x is none of the following protective alleles: DRB1\\*1501, DQB1\\*0503, DRB1\\*1303 will be included regardless of genetic risk score.\n\n\\- Written informed consent signed by the custodial parent(s).\n\nExclusion Criteria:\n\n* Any medical condition, concomitant disease or treatment that may interfere with the assessments or may jeopardize the participant's safe participation in the study, as judged by the investigators.\n* Preterm delivery \\\u003C 36 weeks of gestation.\n* Any condition that could be associated with poor compliance.\n* Diagnosis of diabetes prior to recruitment or randomization.\n* Current use of any investigational drug.","3 Months","4 Months",{"count":62,"type":22},1244,[64],"NA","The aim of this intervention study is to investigate if a intensive dietary and physical activity counselling during the first two years of life in children with increased (genetically) risk for Type 1 Diabetes (T1D) can promote a healthy beta-cell environment, in order to reduce increased weight gain and development of islet autoimmunity (beta-cell autoantibodies).\n\nThe main hypotheses are:\n\n* Early lifestyle influences the susceptibility to islet autoimmunity (IA) by increasing beta-cell vulnerability. Introducing a \"healthy beta-cell lifestyle\" from infancy will reduce beta-cell vulnerability and the likelihood of IA.\n* Will promotion of a healthy beta-cell environment during early childhood in children with increased genetic risk of T1D reduce beta-cell stress, increased weight gain and development of islet autoantibodies?\n\nThe primary objective is to determine whether an Intensive Diet and Activity Counseling (IDAC) from age 3 months to age 2 years improves beta-cell health in children with increased risk for islet autoimmunity.\n\nSecondary objectives are to determine whether IDAC is associated with infant and early childhood growth and body composition and to determine whether IDAC reduces the cumulative incidence of islet autoantibodies or type 1 diabetes in childhood.\n\nParticipants will be randomized (ratio 1:1) to control group and intervention group. Breastfeeding status at time of randomization will be taken into account.\n\nParticipants will be enrolled by the age of four months and visit the research clinic ever third months up until the age of 24 months, and then yearly up until the age of 6 years.\n\n* Anthropometric measurements and blood draw will be taken at each visit.\n* Questionnaires focusing on breastfeeding and early infant feeding habits will be used at each visit.\n* 24hrs recalls will be done at the age of 6, 9, 12, 18 and 24 months of age.\n* Physical activity will be estimated using questionnaires (3, 6, 9 months) and accelerometer data (12, 18 and 24 months).\n* Stool samples will be collected at 6, 12 and 18 months of age",[67,30],"Type 1 Diabetes",[69,70],"islet autoimmunity","children","RECRUITING","2026-04-07",{"date":74,"type":42},"2026-04-13",{"date":76,"type":42},"2025-03-15",{"date":78,"type":22},"2031-12-31",{"name":80,"class":49},"Lund University",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":88,"maxAge":18,"enrollmentInfo":89,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":50},"100431799","conception-of-a-diagnosis-prognosis-and-therapeutic-decision-tool-for-patients-with-autoimmunity-and-inflammation-100431799","NCT04902807","Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation","ATRACTion","Inclusion Criteria for controls (patients relatives and unrelated subjects):\n\n* Individuals aged\\\u003C18 y\u002Fo.\n* Individuals \\> 6 kg\n* Individuals not affected by an immune-related disease or not affected by cancer\n* Individuals whose parents have signed an enlightened consent.\n\nInclusion criteria for patients\n\n* Individuals with health insurance.\n* Patients treated at Necker hospital with PIDs and autoimmunity\u002Finflammation related to known genetic defects (cytopenia, Enteropathy Inflammatory bowel disease (IBD), Systemic Lupus Erythematosus (SLE), Juvenile Idiopathic Arthritis (JIA), Familial Hemophagocytic Lymphohistiocytosis (FHL), chronic EBV infection associated (Ca-EBV) with EBV-infected T and\u002For Natural Killer (NK) cells and with a high risk to develop macrophage activation syndrome similar to FHL. See table below for diagnosis inclusion criteria.\n* Individuals aged\\\u003C18 y\u002Fo.\n* Individuals \\> 9 kg\n* Patients whose parents have signed an enlightened consent.\n\nExclusion Criteria:\n\n* Intake of antibiotics within 2 weeks prior inclusion\n* Absence of parent's or child consent form\n* Cytotoxic cancer treatments\n* antiviral treatments (HIV, hepatitis …)\n* Short term life-threatening conditions\n* Individuals placed under judicial protection","1 Year",{"count":90,"type":22},500,"OBSERVATIONAL","The main objective of this study is to generate diagnosis and therapeutic-decision tools through the identification of molecular causes of PIDs with autoimmunity\u002Finflammation and the variability in disease outcome at the transcriptional level using a combination of omics signatures (transcriptomics, epigenomics, proteomics, metagenomics, metabolomics and lipidomics).",[94,95,96,97,98,99,30,100,101,102,103,104,105,106,107,108,109,110,111,112],"Autoimmune Lymphoproliferative Syndrome","Autoimmune Cytopenia","Autoimmune Diseases","Autoimmune Anemia","Autoimmune Thrombocytopenia","Autoimmune Hepatitis","Autoimmune Rheumatologic Disease","Systemic Lupus Erythematosus","Juvenile Idiopathic Arthritis","Hemophagocytic Lymphohistiocytoses","EBV Lymphoproliferation","RAS-Associated Autoimmune Leucoproliferative Disease","Primary Immunodeficiency","APECED","IPEX","BENTA","Enteropathy, Autoimmune","Combined Immunodeficiency","IBD","2025-09-02",{"date":115,"type":42},"2025-09-08",{"date":117,"type":42},"2021-09-07",{"date":119,"type":22},"2026-06",{"name":121,"class":122},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":23,"phases":133,"briefSummary":135,"conditions":136,"keywords":137,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":50},"100416105","phase-4-effects-of-berberine-plus-inulin-on-diabetes-care-in-patients-with-lada-100416105","NCT04698330","Effects Of Berberine Plus Inulin On Diabetes Care in Patients With LADA","Effects of Berberine Plus Inulin on Diabetes Care in Patients With Latent Autoimmune Diabetes in Adults: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Diabetes diagnosed according to the report of WHO in 1999；\n2. Meet the Chinese Diabetes Society diagnostic criteria (2012) for LADA: (1)glutamic acid decarboxylase antibody (GADA) positive; (2) age at diagnosis ≧ 18 years old; (3) independent on insulin for more than 6 months after diagnosis;\n3. Aged between 18 and 70 years old;\n4. 7.0%≤HbA1c ≤10.0%;\n5. BMI ≥ 18.5 kg\u002Fm2, and no more than 37.5 kg\u002Fm2;\n6. Written informed consent from the patient or family representative.\n\nExclusion Criteria:\n\n1. Severe liver dysfunction (ALT and AST greater than 3 times the upper limit of detection);\n2. eGFR \\\u003C 50ml\u002F(min • 1.73 m2);\n3. Evidence of acute or chronic infection affecting glycemic control within 4 weeks prior to the first visit;\n4. History of any malignancy;\n5. Pregnancy, breastfeeding, or planned pregnancy during the study period;\n6. Secondary diabetes;\n7. Presence of acute complications (ketoacidosis, lactic acidosis or hyperosmolar coma);\n8. Severe organic heart disease, including but not limited to congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, etc., New York Heart Association (NYHA) heart function classification ≥Grade III;\n9. Chronic use of systemic glucocorticoids or other immunosuppressive agents for over 3 months，or use of antibiotic medications or other interventions that could affect the gastrointestinal tract for 2 months before the screening and during the whole study period.\n10. History of hemolytic anemia or glucose-6-phosphate dehydrogenase deficiency.\n11. Allergic to berberine or any components in the combinations.","70 Years",{"count":132,"type":22},240,[134],"PHASE4","The primary purpose of this study is to evaluate the effects of oral berberine (BBR) and inulin combined with insulin therapy on diabetes care in patients with LADA.",[29,30],[138,139,140,141],"LADA","Berberine","Inulin","Diabetes Care","2022-02-08",{"date":144,"type":42},"2022-02-25",{"date":146,"type":22},"2022-05",{"date":148,"type":22},"2026-12",{"name":150,"class":49},"Second Xiangya Hospital of Central South University"]