AI-Driven Metabolic Cohort in Overweight/Obese Chinese Adults

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

First listed

May 13, 2026

Start date

May 1, 2026

Status verified

Apr 2026

Primary completion

Apr 1, 2032

Completion

Apr 1, 2032

Study Design

Enrollment

2,800 participants (estimated)

Arms

• Arm: 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).
• Arm: 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).
• Arm: 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%.

Primary Outcome Measure

Phenotype Transition Rate [ Time Frame: Baseline, 2.5 years, 5 years ]

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