AI-Driven Metabolic Cohort in Overweight/Obese Chinese Adults
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorZhujiang Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,800 Participants
are grouped into 3 trial groupsGroup A: MH-OW/OB
Group B: MU-OW/OB
Group C: T2DM-OW/OB
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 2.5 years, 5 years2
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.
Time frame
Baseline, 2.5 years, 5 yearsSecondary outcomes
1
Longitudinal Changes in Metabolic Parameters
Absolute change and annual rate of change from baseline to 2.5 and 5 years for weight, BMI, waist circumference, hip circumference, waist-to-hip ratio, waist-to-height ratio, body fat mass, body fat percentage, muscle mass, visceral fat area, fasting glucose, fasting insulin, fasting C-peptide, HOMA-IR, HbA1c, total cholesterol, triglycerides, HDL-C, LDL-C, ALT, AST, creatinine, urea, uric acid.
Time frame
Baseline, 2.5 years, 5 years2
Diabetic Microvascular Complications
Incidence and progression of diabetic nephropathy and diabetic retinopathy. (Diabetic neuropathy is also assessed but not included as a formal outcome for this measure.)
Time frame
Baseline, 2.5 years, 5 years3
Major Adverse Cardiovascular Events
Time to first occurrence of myocardial infarction, stroke, coronary revascularization, or cardiovascular death.
Time frame
Baseline, 2.5 years, 5 years4
All-Cause Mortality
Death from any cause.
Time frame
Baseline, 2.5 years, 5 yearsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: