AI-Driven Metabolic Cohort in Overweight/Obese Chinese Adults

NCT07584330 | Not Yet Recruiting

• 1 other identifier: COMET-AI
• Study Type: observational
• Target: 2,800
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Overweight and Obesity; Prediabetic State; Diabetes Mellitus, Type 2; Metabolic Syndrome

Keywords

Overweight and Obesity; Type 2 Diabetes Mellitus; Metabolic Syndrome; Metabolic Phenotype; Prospective Study; Cohort Study

Outcome Measures

Primary Outcomes (2)

• Phenotype Transition Rate

  Conversion from metabolically healthy overweight/obesity (MH-OW/OB) to metabolically unhealthy overweight/obesity (MU-OW/OB) or to type 2 diabetes with overweight/obesity (T2DM-OW/OB); including transition rate and time to transition.

  Baseline, 2.5 years, 5 years

• Complications in T2DM-OW/OB Group

  Incidence of new-onset diabetic complications (nephropathy, retinopathy, neuropathy) and progression of pre-existing complications in participants with type 2 diabetes and overweight/obesity.

  Baseline, 2.5 years, 5 years

Secondary Outcomes (5)

• Longitudinal Changes in Metabolic Parameters

  Baseline, 2.5 years, 5 years

• Diabetic Microvascular Complications

  Baseline, 2.5 years, 5 years

• Major Adverse Cardiovascular Events

  Baseline, 2.5 years, 5 years

• All-Cause Mortality

  Baseline, 2.5 years, 5 years

• Cardiovascular Risk Comparison Across Phenotypes

  Baseline, 2.5 years, 5 years

Study Arms (3)

MH-OW/OB

Participants with overweight or obesity without diabetes; HbA1c \< 5.7% and fasting glucose \< 5.6 mmol/L; no metabolic abnormalities (blood pressure \<130/85 mmHg or no antihypertensives; triglycerides \<1.7 mmol/L or no lipid-lowering drugs; HDL-C ≥1.0 mmol/L for men or ≥1.3 mmol/L for women).

MU-OW/OB

Participants with overweight or obesity without diabetes; HbA1c \< 6.5% and fasting glucose \< 7.0 mmol/L; at least one metabolic abnormality (blood pressure ≥130/85 mmHg or on antihypertensives; triglycerides ≥1.7 mmol/L or on lipid-lowering drugs; HDL-C \<1.0 mmol/L for men or \<1.3 mmol/L for women; or fasting glucose 5.6-6.9 mmol/L).

T2DM-OW/OB

Participants with overweight or obesity with established type 2 diabetes (fasting glucose ≥7.0 mmol/L, 2h-post-OGTT glucose ≥11.1 mmol/L, HbA1c ≥6.5%, or random glucose ≥11.1 mmol/L with typical symptoms); stable antidiabetic treatment for ≥3 months; screening HbA1c ≤ 9.0%.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Chinese adults aged 18-60 years with overweight or obesity (BMI ≥ 24 kg/m² or central obesity: male waist circumference ≥ 90 cm, female ≥ 85 cm). Enrolled from 24 hospitals across China. Participants are classified into three groups: metabolically healthy overweight/obesity (MH-OW/OB), metabolically unhealthy overweight/obesity (MU-OW/OB), and type 2 diabetes with overweight/obesity (T2DM-OW/OB). All participants must be able to use a smartphone for daily communication and provide written informed consent. Key exclusions include type 1 diabetes, severe hepatic/renal impairment, uncontrolled hypertension or diabetes (HbA1c \> 9.0%), active malignancy, pregnancy, and conditions interfering with follow-up or AI platform use.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

MeSH Terms

Conditions

Overweight; Obesity; Diabetes Mellitus, Type 2; Prediabetic State; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 1, 2032
• Study Completion (Estimated): April 1, 2032
• Last Updated: May 13, 2026

Record last verified: 2026-04