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

Korábbi kezelés

• 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.

Más betegség

• 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.

Laborértékek

• 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.

Egyéb

• Pregnant or breastfeeding women.
• Fasting C-peptide \<0.81 ng/mL.
• Calcitonin ≥50 pg/mL.

• 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.