AI-Assisted Lifestyle Intervention Versus Tirzepatide for Obesity and Newly Diagnosed Type 2 Diabetes

Ki vehet részt

• Male or female participants aged 18 to 65 years
• 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/L, fasting blood glucose ≥7.0 mmol/L, 2-hour postprandial blood glucose ≥11.1 mmol/L, or HbA1c ≥6.5% and ≤10.0%. Participants without typical diabetes symptoms should have repeat testing for confirmation
• Body mass index ≥28 kg/m² and <40 kg/m²
• 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
• Able to communicate with the investigators, willing to comply with the study protocol, and voluntarily sign the informed consent form

Ki nem vehet részt

• Body weight change >5% within 12 weeks before screening
• Severe trauma, severe infection, or surgery within 1 month before screening that may affect glycemic control
• Severe cardiovascular or cerebrovascular events within 6 months before screening, including angina, myocardial infarction, arrhythmia, cerebral infarction, cerebral hemorrhage, or other clinically significant events
• Positive urine drug screening and/or drug dependence
• Participation in another clinical trial within 3 months before enrollment or current participation in another drug or device clinical trial
• Type 1 diabetes mellitus, type 2 diabetes requiring insulin treatment, or other specific types of diabetes
• History of acute or chronic pancreatitis, history of pancreatic injury, or amylase >1.5 × upper limit of normal at screening
• 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
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2, or history of thyroid nodules
• History of organ transplantation or acquired or congenital immune system disease
• Schizophrenia or other psychiatric disorder that may interfere with participation in the study
• Unstable or treatment-requiring endocrine disease related to glycemic control, such as hyperthyroidism, acromegaly, or Cushing syndrome, as judged by the investigator
• Hypertension with systolic blood pressure >150 mmHg and/or diastolic blood pressure >90 mmHg after stable antihypertensive treatment
• 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
• Special dietary requirements or allergy to foods such as soy products or dairy products
• Allergic constitution, defined as allergy to two or more categories of substances
• 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
• 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
• Active bacterial, viral, or fungal infection requiring hospitalization or intravenous antibiotic treatment
• Positive HBsAg, HCV antibody, HIV antibody, or Treponema pallidum antibody
• Any other condition that, in the investigator's opinion, makes the participant unsuitable for this study
• Blood dyscrasia or any disease causing hemolysis or unstable red blood cells, or hemoglobinopathy that may affect HbA1c measurement
• Use of medications affecting glucose regulation within 3 months before randomization, such as glucocorticoids, growth hormone, thyroid hormone, sex hormones, cyclosporine, or phenytoin
• Abnormal laboratory results, including AST or ALT >2.5 × upper limit of normal, bilirubin >2.5 × upper limit of normal, triglycerides ≥5.7 mmol/L, estimated creatinine clearance <60 mL/min using the Cockcroft-Gault formula, or clinically significant anemia with hemoglobin <120 g/L in men or <110 g/L in women
• Pregnant or breastfeeding women
• Fasting C-peptide <0.81 ng/mL
• Calcitonin ≥50 pg/mL