Obesity & OverweightNCT07884903
Chinese Overweight/Obesity Cohort: Metabolic & Comorbidity Risks
An observational study of Obesity & Overweight and Diabetes Mellitus, Type 2, run by Shanxi Bethune Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Obesity & Overweight, Diabetes Mellitus, Type 2, Hypertension
- How many people
- 25,974 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 30 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Junwei Wang, Doctor contact
China1 site
Department of Endocrinology, Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032
Junwei Wang, Doctor, +86 13593196178, wangjunwei@sxbqeh.com.cn
About this study
Official title: 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
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.
Read more
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.
- Conditions
- Obesity & Overweight, Diabetes Mellitus, Type 2, Hypertension, Non-alcoholic Fatty Liver Disease (MASLD), Cardiovascular Diseases, Sleep Apnea, Obstructives
- Being tested
- No intervention; observational assessment only
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus, Type 2, Hypertension, Non-alcoholic Fatty Liver Disease, Cardiovascular Diseases, Sleep Apnea Syndromes, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention; observational assessment onlyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Overweight | Adults with BMI 23.0-27.4 kg/m². Target enrollment: 7,785 participants. Receives: Other: No intervention; observational assessment only | |
| Mild Obesity | Adults with BMI 27.5-32.4 kg/m². Target enrollment: 7,785 participants. Receives: Other: No intervention; observational assessment only | |
| Moderate Obesity | Adults with BMI 32.5-37.4 kg/m². Target enrollment: 7,785 participants. Receives: Other: No intervention; observational assessment only | |
| Severe Obesity | Adults with BMI ≥37.5 kg/m². Target enrollment: 2,544 participants. Receives: Other: No intervention; observational assessment only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 years
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
Measured: 3 years
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)
Measured: 3 years
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
Measured: 3 years
Secondary outcomes (7)
Incidence of Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS)
Diagnosed by polysomnography with AHI ≥5 events/hour
Measured: 3 years
Incidence of Polycystic Ovary Syndrome (PCOS)
Diagnosed by Rotterdam criteria in women of reproductive age
Measured: 3 years
Incidence of Osteoarticular Disease
New-onset lumbar/knee/hip joint disease confirmed by imaging
Measured: 3 years
Incidence of Hyperuricemia
Serum uric acid >420 μmol/L (men) or >360 μmol/L (women)
Measured: 3 years
Incidence of Dyslipidemia
New-onset abnormal lipid profile requiring treatment per guidelines
Measured: 3 years
Incidence of Microalbuminuria
Urine albumin-to-creatinine ratio ≥30 mg/g on 2 occasions
Measured: 3 years
Progression of Prediabetes to Diabetes
Conversion from prediabetes (IFG/IGT) to overt type 2 diabetes
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,974 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Bethune Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shiwei Liu, MD, Principal investigator, Shanxi Bethune Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884903
- Sponsor's protocol ID
- YXLL-2026-105
- Status last verified
- Jul 2026
- First submitted
- 13 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07884903
- Acronym / sponsor ID
- YXLL-2026-105
- Conditions
- Obesity & Overweight, Diabetes Mellitus, Type 2, Hypertension, Non-alcoholic Fatty Liver Disease (MASLD), Cardiovascular Diseases, Sleep Apnea, Obstructives
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25,974 participants (estimated)
- Lead sponsor
- Shanxi Bethune HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Overweight | – | Other: No intervention; observational assessment onlyAdults with BMI 23.0-27.4 kg/m². Target enrollment: 7,785 participants. |
| Mild Obesity | – | Other: No intervention; observational assessment onlyAdults with BMI 27.5-32.4 kg/m². Target enrollment: 7,785 participants. |
| Moderate Obesity | – | Other: No intervention; observational assessment onlyAdults with BMI 32.5-37.4 kg/m². Target enrollment: 7,785 participants. |
| Severe Obesity | – | Other: No intervention; observational assessment onlyAdults with BMI ≥37.5 kg/m². Target enrollment: 2,544 participants. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention; observational assessment onlyThis 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. | Other | Mild Obesity, Moderate Obesity, Overweight, Severe Obesity |
Primary outcome
Incidence of Type 2 Diabetes Mellitus
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
7 secondary outcomes
Incidence of Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS)
Time frame: 3 years
Incidence of Polycystic Ovary Syndrome (PCOS)
Time frame: 3 years
Incidence of Osteoarticular Disease
Time frame: 3 years
Incidence of Hyperuricemia
Time frame: 3 years
Incidence of Dyslipidemia
Time frame: 3 years
Incidence of Microalbuminuria
Time frame: 3 years
Progression of Prediabetes to Diabetes
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Junwei Wang, Doctor contact
Shiwei Liu, MD principal investigator
Shanxi Bethune Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity & Overweight and Diabetes Mellitus, Type 2, run by Shanxi Bethune Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiwei Liu, Doctor (+86 13191072733, Iswspring6@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Type 2 Diabetes Mellitus (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.