AI-Driven Metabolic Cohort in Overweight/Obese Chinese Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Overweight and Obesity, Diabetes Mellitus, Type 2, Prediabetic State, Metabolic Syndrome. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Chinese Overweight/Obese - Diabetes Metabolic Spectrum Cohort: An Artificial Intelligence-Driven Prospective Study
Overview
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.
Primary outcome measures
- Phenotype Transition Rate [Time frame: Baseline, 2.5 years, 5 years]
- Complications in T2DM-OW/OB Group [Time frame: Baseline, 2.5 years, 5 years]
Secondary outcome measures (5)
- Longitudinal Changes in Metabolic Parameters [Time frame: Baseline, 2.5 years, 5 years]
- Diabetic Microvascular Complications [Time frame: Baseline, 2.5 years, 5 years]
- Major Adverse Cardiovascular Events [Time frame: Baseline, 2.5 years, 5 years]
- All-Cause Mortality [Time frame: Baseline, 2.5 years, 5 years]
- Cardiovascular Risk Comparison Across Phenotypes [Time frame: Baseline, 2.5 years, 5 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07584330 · COMET-AI