Diabetes Mellitus, Type 2, Metabolic Syndrome, Overweight and Obesity, Prediabetic State
Conditions
Keywords
Overweight and Obesity, Type 2 Diabetes Mellitus, Metabolic Syndrome, Metabolic Phenotype, Prospective Study, Cohort Study
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.
Interventions
None listed
Sponsors
Zhujiang Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Able to understand and voluntarily sign the informed consent form, and willing to comply with all study requirements. 2. Age between 18 and 60 years (inclusive). 3. 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. 4. Capable of basic smartphone operation and able to use WeChat or similar communication tools for daily communication.
Exclusion criteria
1. Diagnosis of type 1 diabetes, latent autoimmune diabetes in adults (LADA), maturity-onset diabetes of the young (MODY), or other specific types of diabetes. 2. 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. 3. Severe liver disease (Child-Pugh class B or C). 4. Renal insufficiency (estimated glomerular filtration rate \< 30 mL/min/1.73 m²). 5. Severe cardiac dysfunction (New York Heart Association class III or IV). 6. Major cardiovascular or cerebrovascular event within the past 3 months (acute coronary syndrome, stroke). 7. Uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg or diastolic ≥ 110 mmHg) or uncontrolled diabetes (HbA1c ≥ 9.0%). 8. Active malignancy (diagnosed or treated within the last 3 years). 9. Inflammatory bowel disease or conditions causing malabsorption (Crohn disease, active ulcerative colitis, pancreatitis with steatorrhea). 10. Neuropsychiatric disorders (anorexia nervosa, bulimia nervosa, schizophrenia, major depression, or bipolar disorder). 11. Diseases or physical conditions that impair motor function (severe osteoarthritis, Parkinson disease, paralysis, or cardiopulmonary insufficiency). 12. Long-term use of antipsychotic drugs, systemic glucocorticoids, or other medications judged by the investigator to affect study outcomes. 13. Pregnancy or planned pregnancy during the study period. 14. History of or planned organ transplantation. 15. Inability to operate the AI-based system or comply with follow-up procedures. 16. Concurrent participation in another interventional clinical trial that may influence the results of this study. 17. Unwilling or unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phenotype Transition Rate | Baseline, 2.5 years, 5 years | 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. |
| Complications in T2DM-OW/OB Group | Baseline, 2.5 years, 5 years | Incidence of new-onset diabetic complications (nephropathy, retinopathy, neuropathy) and progression of pre-existing complications in participants with type 2 diabetes and overweight/obesity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Longitudinal Changes in Metabolic Parameters | Baseline, 2.5 years, 5 years | 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. |
| Diabetic Microvascular Complications | Baseline, 2.5 years, 5 years | Incidence and progression of diabetic nephropathy and diabetic retinopathy. (Diabetic neuropathy is also assessed but not included as a formal outcome for this measure.) |
| Major Adverse Cardiovascular Events | Baseline, 2.5 years, 5 years | Time to first occurrence of myocardial infarction, stroke, coronary revascularization, or cardiovascular death. |
| All-Cause Mortality | Baseline, 2.5 years, 5 years | Death from any cause. |
| Cardiovascular Risk Comparison Across Phenotypes | Baseline, 2.5 years, 5 years | 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. |
Outcome results
None listed