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Not yet recruitingNCT07884903Updated Oct 21, 2026

Chinese Overweight/Obesity Cohort: Metabolic & Comorbidity Risks

An observational study in Obesity & Overweight, Diabetes Mellitus, Type 2 and Hypertension, sponsored by Shanxi Bethune Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Shanxi Bethune Hospital · Observational

Updated Oct 21, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25,974
Ages
18 Years to 79 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity & Overweight
  • Diabetes Mellitus, Type 2
  • Hypertension
  • Non-alcoholic Fatty Liver Disease (MASLD)
  • Cardiovascular Diseases
  • Sleep Apnea, Obstructives
  • Polycystic Ovary Syndrome
  • Hyperuricemia
  • Dyslipidemias
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's planned enrollment of 25,974 is above the median of 132 across 1,338 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Shanxi Bethune Hospital is the lead sponsor of 23 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Overweight and obese adults (BMI ≥23.0 kg/m²) aged 18-79 years from 39 centers across China, stratified into four BMI groups: overweight, mild obesity, moderate obesity, and severe obesity.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25,974 participants (estimated)
Patient registry
No

Groups and cohorts

  • Overweight

    Adults with BMI 23.0-27.4 kg/m². Target enrollment: 7,785 participants.

    Other: No intervention; observational assessment only

  • Mild Obesity

    Adults with BMI 27.5-32.4 kg/m². Target enrollment: 7,785 participants.

    Other: No intervention; observational assessment only

  • Moderate Obesity

    Adults with BMI 32.5-37.4 kg/m². Target enrollment: 7,785 participants.

    Other: No intervention; observational assessment only

  • Severe Obesity

    Adults with BMI ≥37.5 kg/m². Target enrollment: 2,544 participants.

    Other: No intervention; observational assessment only

Interventions

  • OtherNo intervention; observational assessment only

    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.

06

What researchers measure

Primary outcomes

  1. Incidence of Type 2 Diabetes Mellitus

    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)

    Time frame: 3 years

  2. Incidence of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

    3-year incidence of new-onset MASLD diagnosed by abdominal ultrasound and/or FibroScan with hepatic steatosis, excluding other causes of liver disease

    Time frame: 3 years

  3. Incidence of Hypertension

    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)

    Time frame: 3 years

  4. Incidence of Atherosclerotic Cardiovascular Disease (ASCVD)

    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

    Time frame: 3 years

Secondary outcomes

  1. Incidence of Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS)

    Diagnosed by polysomnography with AHI ≥5 events/hour

    Time frame: 3 years

  2. Incidence of Polycystic Ovary Syndrome (PCOS)

    Diagnosed by Rotterdam criteria in women of reproductive age

    Time frame: 3 years

  3. Incidence of Osteoarticular Disease

    New-onset lumbar/knee/hip joint disease confirmed by imaging

    Time frame: 3 years

  4. Incidence of Hyperuricemia

    Serum uric acid \>420 μmol/L (men) or \>360 μmol/L (women)

    Time frame: 3 years

  5. Incidence of Dyslipidemia

    New-onset abnormal lipid profile requiring treatment per guidelines

    Time frame: 3 years

  6. Incidence of Microalbuminuria

    Urine albumin-to-creatinine ratio ≥30 mg/g on 2 occasions

    Time frame: 3 years

  7. Progression of Prediabetes to Diabetes

    Conversion from prediabetes (IFG/IGT) to overt type 2 diabetes

    Time frame: 3 years

07

Study locations

1 site
  • Department of Endocrinology, Shanxi Bethune Hospital
    Taiyuan, Shanxi 030032, China
08

References and documents

Individual participant data

Plan to share: No — If there is a need to use data, please contact the person in charge and follow the relevant procedures to achieve data sharing. Without permission, do not use the data directly.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07884903
Lead sponsor
Shanxi Bethune Hospital
Responsible party
Sponsor
First posted
Oct 21, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Jun 1, 2028 (estimated)
Completion
Sep 30, 2029 (estimated)
Last update
Oct 21, 2026

Study contacts

Shiwei Liu, Doctor
Contact
Iswspring6@aliyun.com
+86 13191072733
Junwei Wang, Doctor
Contact
wangjunwei@sxbqeh.com.cn
Shiwei Liu, MD
principal investigator · Shanxi Bethune Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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