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
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 285
- 试验地点
- 2
- 主要终点
- Percent Change in Body Weight From Baseline to Week 52
研究概览
简要总结
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/m² and newly diagnosed type 2 diabetes who have not used glucose-lowering medications in the past 3 months.
Participants 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Type 1 diabetes mellitus, type 2 diabetes requiring insulin treatment, or other specific types of diabetes.
- •Body weight change >5% within 12 weeks before screening.
- •Pregnant or breastfeeding women.
- •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.
- •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.
- •Blood dyscrasia or any disease causing hemolysis or unstable red blood cells, or hemoglobinopathy that may affect HbA1c measurement.
- •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.
- •Use of medications affecting glucose regulation within 3 months before randomization, such as glucocorticoids, growth hormone, thyroid hormone, sex hormones, cyclosporine, or phenytoin.
- •Allergic constitution, defined as allergy to two or more categories of substances.
- •Fasting C-peptide <0.81 ng/mL.
- •Calcitonin ≥50 pg/mL.
- •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.
- •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.
- •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.
- •Any other condition that, in the investigator's opinion, makes the participant unsuitable for this study.
研究组 & 干预措施
AI-Assisted Intensive Lifestyle Intervention
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.
干预措施: AI-Assisted Intensive Lifestyle Intervention (Behavioral)
AI-Assisted Intensive Lifestyle Intervention
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.
干预措施: Standard Lifestyle Management (Behavioral)
Tirzepatide Treatment
Participants in this arm will receive tirzepatide treatment according to the study protocol, in addition to standardized lifestyle education.
干预措施: Standard Lifestyle Management (Behavioral)
Standard Lifestyle Management
Participants in this arm will receive standardized lifestyle management and health education according to the study protocol.
干预措施: Standard Lifestyle Management (Behavioral)
Tirzepatide Treatment
Participants in this arm will receive tirzepatide treatment according to the study protocol, in addition to standardized lifestyle education.
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Percent Change in Body Weight From Baseline to Week 52
时间窗: Baseline to Week 52
Percent change in body weight from baseline to week 52 will be calculated as \[(body weight at week 52 - body weight at baseline) / body weight at baseline\] × 100%. A negative value indicates weight loss.
次要结局
- Change in HbA1c From Baseline to Week 52(Baseline to Week 52)
- Change in Fasting Plasma Glucose From Baseline to Week 52(Baseline to Week 52)
- Change in Waist Circumference From Baseline to Week 52(Baseline to Week 52)
- Change in Body Mass Index From Baseline to Week 52(Baseline to Week 52)
- Proportion of Participants Achieving Type 2 Diabetes Remission at Week 64(Week 64)
- Change in CGM Time in Range From Baseline to Week 52(Baseline to Week 52)
- Change in CGM Time Above Range From Baseline to Week 52(Baseline to Week 52)
- Change in CGM Time Below Range From Baseline to Week 52(Baseline to Week 52)
- Change in CGM Coefficient of Variation From Baseline to Week 52(Baseline to Week 52)
- Incidence of Adverse Events(From enrollment to Week 64)
- Incidence of Serious Adverse Events(From enrollment to Week 64)