[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100416105":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":49,"centralContacts":54,"locations":59,"responsibleParty":76,"collaborators":36,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":36,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":36,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":102,"whyStopped":36,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Second Xiangya Hospital of Central South University","OTHER",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","EXPERIMENTAL","LADA patients are assigned to receive berberine and inulin for 3-month.",[13,14],"Drug: Berberine","Drug: Inulin",{"label":16,"type":10,"description":17,"interventionNames":18},"Group B","LADA patients are assigned to receive berberine and placebo(for inulin) for 3-month.",[13,19],"Drug: Inulin placebo tablets",{"label":21,"type":10,"description":22,"interventionNames":23},"Group C","LADA patients are assigned to receive placebo(for berberine) and inulin for 3-month.",[14,24],"Drug: Berberine placebo tablets",{"label":26,"type":27,"description":28,"interventionNames":29},"Group D","PLACEBO_COMPARATOR","LADA patients are assigned to receive placebo(for berberine) and placebo(for inulin) for 3-month.",[24,19],[31,37,41,45],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Berberine","0.6g (6 pills) of Berberine tablets administered twice a day orally before meal for 3 months",[9,16],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Inulin","0.6g (6 pills) of Inulin tablets administered twice a day orally before meal for 3 months",[9,21],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"Berberine placebo tablets","0.6g (6 pills) of Berberine placebo tablets administered twice a day orally before meal for 3 months",[21,26],{"type":32,"name":46,"description":47,"armGroupLabels":48,"otherNames":36},"Inulin placebo tablets","0.6g (6 pills) of Inulin placebo tablets administered twice a day orally before meal for 3 months",[16,26],[50],{"name":51,"affiliation":52,"role":53},"Yang Xiao, MD\u002FPhD","Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University, China","PRINCIPAL_INVESTIGATOR",[55],{"name":51,"role":56,"phone":57,"phoneExt":36,"email":58},"CONTACT","86-731-85292154","xiaoyang29@csu.edu.cn",[60],{"facility":61,"status":36,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University","Changsha","Hunan","410011","China","CN",{"type":68,"coordinates":69},"Point",[70,71],112.97087,28.19874,{"lat":71,"lon":70},[74],{"name":51,"role":56,"phone":75,"phoneExt":36,"email":58},"86-0731-85292154",{"type":53,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Yang Xiao","Associate Professor, Department of Metabolism and Endocrinology, Institute of Metabolism and Endocrinology, National Clinical Research Center for Metabolic Diseases, Second Xiangya Hospital, Central South University","100416105","phase-4-effects-of-berberine-plus-inulin-on-diabetes-care-in-patients-with-lada-100416105",false,"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.","ALL","18 Years","70 Years",{"count":90,"type":91},240,"ESTIMATED","INTERVENTIONAL",[94],"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.",[97,98],"Type 1 Diabetes Mellitus","Autoimmune Diabetes",[100,33,38,101],"LADA","Diabetes Care","NOT_YET_RECRUITING","2022-02-08",{"date":105,"type":106},"2022-02-25","ACTUAL",{"date":108,"type":91},"2022-05",{"date":110,"type":91},"2026-12",{"name":5,"class":6},1]