Chinese Overweight/Obese - Diabetes Metabolic Spectrum Cohort: An Artificial Intelligence-Driven Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,800
研究概览
简要总结
The goal of this observational cohort study is to delineate the five-year dynamic trajectories of metabolic phenotypes in Chinese adults with overweight or obesity, with or without type 2 diabetes, focusing on transition rates from metabolically healthy overweight/obesity to unhealthy overweight/obesity or to type 2 diabetes, as well as the incidence and progression of diabetic complications and cardiovascular events in those with type 2 diabetes and overweight/obesity. Researchers will compare three phenotype groups, namely metabolically healthy overweight/obesity, metabolically unhealthy overweight/obesity, and type 2 diabetes with overweight/obesity, to assess differences in metabolic parameter changes, complication rates, and cardiovascular risk. Participants will use a digital health management platform for data upload and lifestyle support, and will complete comprehensive health assessments at baseline, at 2.5 years, and at 5 years, along with annual light follow-ups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and voluntarily sign the informed consent form, and willing to comply with all study requirements.
- •Age between 18 and 60 years (inclusive).
- •Meets at least one of the following overweight/obesity criteria: a) BMI ≥ 24 kg/m²; b) male waist circumference ≥ 90 cm, female waist circumference ≥ 85 cm.
- •Capable of basic smartphone operation and able to use WeChat or similar communication tools for daily communication.
排除标准
- •Diagnosis of type 1 diabetes, latent autoimmune diabetes in adults (LADA), maturity-onset diabetes of the young (MODY), or other specific types of diabetes.
- •Endocrine or metabolic diseases that may affect body weight, including untreated thyroid disorders (hyperthyroidism: TSH < 0.1 mIU/L with FT4 > upper normal limit; hypothyroidism: TSH > 10 mIU/L), Cushing syndrome, acromegaly, polycystic ovary syndrome, or hypopituitarism.
- •Severe liver disease (Child-Pugh class B or C).
- •Renal insufficiency (estimated glomerular filtration rate < 30 mL/min/1.73 m²).
- •Severe cardiac dysfunction (New York Heart Association class III or IV).
- •Major cardiovascular or cerebrovascular event within the past 3 months (acute coronary syndrome, stroke).
- •Uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg or diastolic ≥ 110 mmHg) or uncontrolled diabetes (HbA1c ≥ 9.0%).
- •Active malignancy (diagnosed or treated within the last 3 years).
- •Inflammatory bowel disease or conditions causing malabsorption (Crohn disease, active ulcerative colitis, pancreatitis with steatorrhea).
- •Neuropsychiatric disorders (anorexia nervosa, bulimia nervosa, schizophrenia, major depression, or bipolar disorder).
- •Diseases or physical conditions that impair motor function (severe osteoarthritis, Parkinson disease, paralysis, or cardiopulmonary insufficiency).
- •Long-term use of antipsychotic drugs, systemic glucocorticoids, or other medications judged by the investigator to affect study outcomes.
- •Pregnancy or planned pregnancy during the study period.
- •History of or planned organ transplantation.
- •Inability to operate the AI-based system or comply with follow-up procedures.
- •Concurrent participation in another interventional clinical trial that may influence the results of this study.
- •Unwilling or unable to provide informed consent.