[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053367":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":30,"centralContacts":39,"locations":45,"responsibleParty":69,"collaborators":71,"id":75,"slug":30,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":30,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":101,"whyStopped":30,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"The First Affiliated Hospital of Anhui Medical University","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"AI-Assisted Intensive Lifestyle Intervention","EXPERIMENTAL","Participants in this arm will receive an AI-assisted intensive lifestyle intervention, including individualized dietary and lifestyle guidance supported by an AI-based platform and nutritionist follow-up, in addition to standardized lifestyle education.",[13,14],"Behavioral: AI-Assisted Intensive Lifestyle Intervention","Behavioral: Standard Lifestyle Management",{"label":16,"type":17,"description":18,"interventionNames":19},"Tirzepatide Treatment","ACTIVE_COMPARATOR","Participants in this arm will receive tirzepatide treatment according to the study protocol, in addition to standardized lifestyle education.",[20,14],"Drug: Tirzepatide",{"label":22,"type":17,"description":23,"interventionNames":24},"Standard Lifestyle Management","Participants in this arm will receive standardized lifestyle management and health education according to the study protocol.",[14],[26,31,36],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"BEHAVIORAL","An intensive lifestyle intervention supported by an AI-based platform and nutritionist follow-up, including individualized dietary guidance, lifestyle behavior support, and weight management counseling.",[9],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":30},"DRUG","Tirzepatide","Tirzepatide will be administered by subcutaneous injection once weekly according to the protocol-defined dose titration and tolerability assessment.",[16],{"type":27,"name":22,"description":37,"armGroupLabels":38,"otherNames":30},"Standardized lifestyle management and health education, including general dietary, physical activity, and weight management advice according to the study protocol.",[9,22,16],[40],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},"Xueying Zheng","CONTACT","+8619966188536","lisazhengxy@163.com",[46,61],{"facility":5,"status":30,"city":47,"state":48,"zip":49,"country":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Hefei","Anhui","230022","China",{"type":52,"coordinates":53},"Point",[54,55],117.28083,31.86389,{"lat":55,"lon":54},[58],{"name":59,"role":42,"phone":43,"phoneExt":30,"email":60},"Meiwen He","hemeiwen0128@163.com",{"facility":62,"status":30,"city":47,"state":48,"zip":63,"country":50,"cosmosGeoPoint":64,"geoPoint":66,"contacts":67},"The Second Affiliated Hospital of Anhui Medical University","230601",{"type":52,"coordinates":65},[54,55],{"lat":55,"lon":54},[68],{"name":59,"role":42,"phone":43,"phoneExt":30,"email":60},{"type":70,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[72],{"name":73,"class":74},"Zhejiang Nutriease Health Technology Co. Ltd.","INDUSTRY","100053367",false,"NCT07697391","AI-Assisted Lifestyle Intervention Versus Tirzepatide for Obesity and Newly Diagnosed Type 2 Diabetes","A Multicenter Randomized Controlled Trial Evaluating AI-Assisted Intensive Lifestyle Intervention Versus Tirzepatide for Glycemic and Weight Management in Patients With Obesity and Newly Diagnosed Type 2 Diabetes","AI-LIFE-T2D-OB","Inclusion Criteria:\n\n1. Male or female participants aged 18 to 65 years.\n2. Newly diagnosed type 2 diabetes mellitus, defined as diagnosis within 3 years and no use of glucose-lowering medications within the past 3 months. Diagnosis should meet the 1999 World Health Organization criteria, including at least one of the following: random plasma glucose ≥11.1 mmol\u002FL, fasting blood glucose ≥7.0 mmol\u002FL, 2-hour postprandial blood glucose ≥11.1 mmol\u002FL, or HbA1c ≥6.5% and ≤10.0%. Participants without typical diabetes symptoms should have repeat testing for confirmation.\n3. Body mass index ≥28 kg\u002Fm² and \\\u003C40 kg\u002Fm².\n4. Willing to use effective contraception and have no pregnancy plan within 12 months after signing the informed consent form; female participants must have a negative pregnancy test at screening.\n5. Able to communicate with the investigators, willing to comply with the study protocol, and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. Type 1 diabetes mellitus, type 2 diabetes requiring insulin treatment, or other specific types of diabetes.\n2. Body weight change \\>5% within 12 weeks before screening.\n3. Pregnant or breastfeeding women.\n4. Severe trauma, severe infection, or surgery within 1 month before screening that may affect glycemic control.\n5. Severe cardiovascular or cerebrovascular events within 6 months before screening, including angina, myocardial infarction, arrhythmia, cerebral infarction, cerebral hemorrhage, or other clinically significant events.\n6. History of acute or chronic pancreatitis, history of pancreatic injury, or amylase \\>1.5 × upper limit of normal at screening.\n7. Current or previous malignancy, except local basal cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the prostate; diagnosis of malignancy within 5 years before screening.\n8. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2, or history of thyroid nodules.\n9. Blood dyscrasia or any disease causing hemolysis or unstable red blood cells, or hemoglobinopathy that may affect HbA1c measurement.\n10. History of organ transplantation or acquired or congenital immune system disease.\n11. Schizophrenia or other psychiatric disorder that may interfere with participation in the study.\n12. Unstable or treatment-requiring endocrine disease related to glycemic control, such as hyperthyroidism, acromegaly, or Cushing syndrome, as judged by the investigator.\n13. Hypertension with systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\>90 mmHg after stable antihypertensive treatment.\n14. Clinically significant abnormal gastric emptying, severe chronic gastrointestinal disease, diabetic gastroparesis, long-term use of medications directly affecting gastrointestinal motility, or history of gastrointestinal surgery.\n15. Special dietary requirements or allergy to foods such as soy products or dairy products.\n16. Use of medications affecting glucose regulation within 3 months before randomization, such as glucocorticoids, growth hormone, thyroid hormone, sex hormones, cyclosporine, or phenytoin.\n17. Allergic constitution, defined as allergy to two or more categories of substances.\n18. Fasting C-peptide \\\u003C0.81 ng\u002FmL.\n19. Calcitonin ≥50 pg\u002FmL.\n20. Abnormal laboratory results, including AST or ALT \\>2.5 × upper limit of normal, bilirubin \\>2.5 × upper limit of normal, triglycerides ≥5.7 mmol\u002FL, estimated creatinine clearance \\\u003C60 mL\u002Fmin using the Cockcroft-Gault formula, or clinically significant anemia with hemoglobin \\\u003C120 g\u002FL in men or \\\u003C110 g\u002FL in women.\n21. Unstable proliferative retinopathy or maculopathy requiring urgent treatment within 1 year before randomization, or history of diabetic ketoacidosis, hyperosmolar nonketotic coma, or severe metabolic disorder causing neuropsychiatric dysfunction.\n22. History or risk factors of epilepsy, syncope, cardiac arrest, arrhythmia, atrioventricular block, structural heart disease, torsades de pointes, hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, or hypocalcemia.\n23. Active bacterial, viral, or fungal infection requiring hospitalization or intravenous antibiotic treatment.\n24. Positive HBsAg, HCV antibody, HIV antibody, or Treponema pallidum antibody.\n25. Positive urine drug screening and\u002For drug dependence.\n26. Participation in another clinical trial within 3 months before enrollment or current participation in another drug or device clinical trial.\n27. Any other condition that, in the investigator's opinion, makes the participant unsuitable for this study.","ALL","18 Years","65 Years",{"count":86,"type":87},285,"ESTIMATED","INTERVENTIONAL",[90],"PHASE4","This multicenter randomized controlled trial will evaluate whether an AI-assisted intensive lifestyle intervention can improve weight and glycemic management in adults with obesity and newly diagnosed type 2 diabetes, compared with tirzepatide treatment and standard lifestyle management. Eligible participants will be adults aged 18 to 65 years with a body mass index of 28 to less than 40 kg\u002Fm² and newly diagnosed type 2 diabetes who have not used glucose-lowering medications in the past 3 months.\n\nParticipants will be randomly assigned to one of three groups: an AI-assisted intensive lifestyle intervention group, a tirzepatide treatment group, or a standard lifestyle management control group. The intervention period will last 52 weeks, followed by a 12-week post-intervention follow-up period. The main outcome is the percentage change in body weight at week 52. The study will also assess glycemic control, body composition, continuous glucose monitoring metrics, safety, and other metabolic outcomes.",[93,94],"Obesity","Diabetes Mellitus, Type 2",[96,33,97,98,99,100],"AI-Assisted Lifestyle Intervention","Weight Management","Glycemic Control","Continuous Glucose Monitoring","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-07-10",{"date":104,"type":105},"2026-07-13","ACTUAL",{"date":107,"type":87},"2026-07-20",{"date":109,"type":87},"2028-01-31",{"name":5,"class":6},2]