Chinese Overweight/Obesity Cohort: Metabolic & Comorbidity Risks

NCT07884903 — Not yet recruiting, 25974 participants, Shanxi Bethune Hospital

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A National Multicenter Prospective Cohort Study on the Incidence Characteristics and Risk Associations of Metabolic and Multi-system Comorbidities in Overweight and Obese Populations Stratified by Body Mass Index

Registry	NCT07884903
Status	Not yet recruiting
Study type	Observational
Enrollment	25974 (Estimated)
Sponsor	Shanxi Bethune Hospital (Other)
Conditions	Obesity & Overweight, Diabetes Mellitus, Type 2, Hypertension, Non-alcoholic Fatty Liver Disease (MASLD), Cardiovascular Diseases, Sleep Apnea, Obstructives, Polycystic Ovary Syndrome, Hyperuricemia, Dyslipidemias
Interventions	No intervention; observational assessment only (Other)
Dates	start 2026-11-01 (estimated), primary completion 2028-06-01 (estimated), completion 2029-09-30 (estimated), first posted 2026-10-21, last updated 2026-10-21
Locations	1 site in China

-Summary

This is a nationwide, multi-center, long-term follow-up study of overweight and obese adults in China. The study aims to recruit approximately 26,000 participants across 39 hospitals to better understand how body weight affects the development of obesity-related diseases over a 3-year period.

Eligible participants are adults aged 18 to 79 years with a body mass index (BMI) of 23 kg/m² or higher. Participants will be grouped into four categories based on their BMI: overweight, mild obesity, moderate obesity, and severe obesity.

At the beginning of the study, all participants will undergo a comprehensive health assessment, including physical measurements, body composition analysis, blood tests, and lifestyle questionnaires. Participants will then be followed for 3 years with annual check-ins to track any new health conditions.

The main goal is to identify the 3-year risk of developing conditions such as type 2 diabetes, fatty liver disease, high blood pressure, and heart disease in different weight groups. This information will help doctors better predict and prevent obesity-related health problems in the future.

Participation is voluntary, and all personal information will be kept confidential.

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+Arms and interventions

Arm	Interventions	Description
Overweight	Other: No intervention; observational assessment only	Adults with BMI 23.0-27.4 kg/m². Target enrollment: 7,785 participants.
Mild Obesity	Other: No intervention; observational assessment only	Adults with BMI 27.5-32.4 kg/m². Target enrollment: 7,785 participants.
Moderate Obesity	Other: No intervention; observational assessment only	Adults with BMI 32.5-37.4 kg/m². Target enrollment: 7,785 participants.
Severe Obesity	Other: No intervention; observational assessment only	Adults with BMI ≥37.5 kg/m². Target enrollment: 2,544 participants.

No intervention; observational assessment only (Other): This is an observational cohort study with no intervention. Participants will undergo standardized health assessments and follow-up visits, but no investigational drug, device, or behavioral intervention will be administered. All data collection is purely observational to document the natural course of obesity-related comorbidities.

+Outcome measures

Primary outcomes

Incidence of Type 2 Diabetes Mellitus [3 years]: 3-year incidence of new-onset type 2 diabetes mellitus diagnosed according to ADA criteria (fasting glucose ≥7.0 mmol/L, HbA1c ≥6.5%, or 2h OGTT ≥11.1 mmol/L)
Incidence of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) [3 years]: 3-year incidence of new-onset MASLD diagnosed by abdominal ultrasound and/or FibroScan with hepatic steatosis, excluding other causes of liver disease
Incidence of Hypertension [3 years]: 3-year incidence of new-onset hypertension (systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg on at least 2 occasions, or initiation of antihypertensive medication)
Incidence of Atherosclerotic Cardiovascular Disease (ASCVD) [3 years]: 3-year incidence of ASCVD events including coronary heart disease, cerebral infarction, transient ischemic attack (TIA), and peripheral artery disease, confirmed by clinical diagnosis and imaging

Secondary outcomes

Incidence of Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) [3 years]: Diagnosed by polysomnography with AHI ≥5 events/hour
Incidence of Polycystic Ovary Syndrome (PCOS) [3 years]: Diagnosed by Rotterdam criteria in women of reproductive age
Incidence of Osteoarticular Disease [3 years]: New-onset lumbar/knee/hip joint disease confirmed by imaging
Incidence of Hyperuricemia [3 years]: Serum uric acid >420 μmol/L (men) or >360 μmol/L (women)
Incidence of Dyslipidemia [3 years]: New-onset abnormal lipid profile requiring treatment per guidelines
Incidence of Microalbuminuria [3 years]: Urine albumin-to-creatinine ratio ≥30 mg/g on 2 occasions
Progression of Prediabetes to Diabetes [3 years]: Conversion from prediabetes (IFG/IGT) to overt type 2 diabetes

+Eligibility

Sex: All, ages: 18 Years to 79 Years

Inclusion Criteria:

* Adults aged 18 to 79 years
* BMI ≥23.0 kg/m² (overweight or obese per 2026 ADA criteria)
* Able to provide written informed consent
* Capable of completing baseline assessment and 3-year follow-up
* Local residency for ≥3 years
* Willing to provide fasting blood samples for storage

Exclusion Criteria:

* Secondary obesity (Cushing's syndrome, hypothyroidism, drug-induced or genetic obesity)
* End-stage severe chronic diseases (refractory heart failure, advanced malignancy, AIDS)
* Severe psychiatric disorders or cognitive impairment
* Pregnancy or lactation
* Concurrent participation in other weight-loss or metabolic intervention trials

+Locations (1)

Facility	City	Country	Status
Department of Endocrinology, Shanxi Bethune Hospital	Taiyuan, Shanxi	China

+Investigators

Shiwei Liu, MD, Principal investigator, Shanxi Bethune Hospital