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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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%. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| D011236 | Prediabetic State |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Baseline, 2.5 years, 5 years |
| 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.) | Baseline, 2.5 years, 5 years |
| Major Adverse Cardiovascular Events | Time to first occurrence of myocardial infarction, stroke, coronary revascularization, or cardiovascular death. | Baseline, 2.5 years, 5 years |
| All-Cause Mortality | Death from any cause. | Baseline, 2.5 years, 5 years |
| Cardiovascular Risk Comparison Across Phenotypes | Cumulative incidence and hazard ratio of cardiovascular events (myocardial infarction, stroke, revascularization) among the three phenotype groups (MH-OW/OB, MU-OW/OB, T2DM-OW/OB) over 5 years of follow-up. | Baseline, 2.5 years, 5 years |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |