Overweight and ObesityCOMET-AINCT07584330
AI-Driven Metabolic Cohort in Overweight/Obese Chinese Adults
An observational study of Overweight and Obesity and Diabetes Mellitus, Type 2, run by Zhujiang Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Overweight and Obesity, Diabetes Mellitus, Type 2, Prediabetic State
- How many people
- 2,800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 1 Apr 2032
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Chinese adults aged 18-60 years with overweight or obesity (BMI ≥ 24 kg/m² or central obesity: male waist circumference ≥ 90 cm, female ≥ 85 cm). Enrolled from 24 hospitals across China. Participants are classified into three groups: metabolically healthy overweight/obesity (MH-OW/OB), metabolically unhealthy overweight/obesity (MU-OW/OB), and type 2 diabetes with overweight/obesity (T2DM-OW/OB). All participants must be able to use a smartphone for daily communication and provide written informed consent. Key exclusions include type 1 diabetes, severe hepatic/renal impairment, uncontrolled hypertension or diabetes (HbA1c > 9.0%), active malignancy, pregnancy, and conditions interfering with follow-up or AI platform use.
Who may be able to join
- Able to understand and voluntarily sign the informed consent form, and willing to comply with all study requirements.
- Age between 18 and 60 years (inclusive).
- 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.
- Capable of basic smartphone operation and able to use WeChat or similar communication tools for daily communication.
Who cannot join
- Diagnosis of type 1 diabetes, latent autoimmune diabetes in adults (LADA), maturity-onset diabetes of the young (MODY), or other specific types of diabetes.
- 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.
- Severe liver disease (Child-Pugh class B or C).
- Renal insufficiency (estimated glomerular filtration rate < 30 mL/min/1.73 m²).
- Severe cardiac dysfunction (New York Heart Association class III or IV).
- Major cardiovascular or cerebrovascular event within the past 3 months (acute coronary syndrome, stroke).
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- Uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg or diastolic ≥ 110 mmHg) or uncontrolled diabetes (HbA1c ≥ 9.0%).
- Active malignancy (diagnosed or treated within the last 3 years).
- Inflammatory bowel disease or conditions causing malabsorption (Crohn disease, active ulcerative colitis, pancreatitis with steatorrhea).
- Neuropsychiatric disorders (anorexia nervosa, bulimia nervosa, schizophrenia, major depression, or bipolar disorder).
- Diseases or physical conditions that impair motor function (severe osteoarthritis, Parkinson disease, paralysis, or cardiopulmonary insufficiency).
- Long-term use of antipsychotic drugs, systemic glucocorticoids, or other medications judged by the investigator to affect study outcomes.
- Pregnancy or planned pregnancy during the study period.
- History of or planned organ transplantation.
- Inability to operate the AI-based system or comply with follow-up procedures.
- Concurrent participation in another interventional clinical trial that may influence the results of this study.
- Unwilling or unable to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital
Guangzhou, Guangdong, 510280
Hong Chen, Ph.D., +86 20 61643888, rubychfq@163.com
About this study
Official title: Chinese Overweight/Obese - Diabetes Metabolic Spectrum Cohort: An Artificial Intelligence-Driven Prospective Study
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.
- Keywords
- Overweight and Obesity, Type 2 Diabetes Mellitus, Metabolic Syndrome, Metabolic Phenotype, Prospective Study, Cohort Study
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 2, Prediabetic State, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). | |
| 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). | |
| 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%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotype Transition Rate
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.
Measured: Baseline, 2.5 years, 5 years
Complications in T2DM-OW/OB Group
Incidence of new-onset diabetic complications (nephropathy, retinopathy, neuropathy) and progression of pre-existing complications in participants with type 2 diabetes and overweight/obesity.
Measured: Baseline, 2.5 years, 5 years
Secondary outcomes (5)
Longitudinal Changes in Metabolic Parameters
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.
Measured: Baseline, 2.5 years, 5 years
Diabetic Microvascular Complications
Incidence and progression of diabetic nephropathy and diabetic retinopathy. (Diabetic neuropathy is also assessed but not included as a formal outcome for this measure.)
Measured: Baseline, 2.5 years, 5 years
Major Adverse Cardiovascular Events
Time to first occurrence of myocardial infarction, stroke, coronary revascularization, or cardiovascular death.
Measured: Baseline, 2.5 years, 5 years
All-Cause Mortality
Death from any cause.
Measured: Baseline, 2.5 years, 5 years
Cardiovascular Risk Comparison Across Phenotypes
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.
Measured: Baseline, 2.5 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Jul 2026
- Primary completion1 Apr 2032 (estimated)
- Study completion1 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- 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
- 2,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584330
- Sponsor's protocol ID
- COMET-AI
- Acronym
- COMET-AI
- Status last verified
- Apr 2026
- First submitted
- 7 May 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Overweight/Obese - Diabetes Metabolic Spectrum Cohort: An Artificial Intelligence-Driven Prospective Study
- ClinicalTrials.gov ID
- NCT07584330
- Acronym / sponsor ID
- COMET-AI / COMET-AI
- Keywords
- Overweight and Obesity, Type 2 Diabetes Mellitus, Metabolic Syndrome, Metabolic Phenotype, Prospective Study, Cohort Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Apr 2032 (estimated)
- Study completion
- 1 Apr 2032 (estimated)
- First posted
- 13 May 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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). |
| 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). |
| 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%. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Chinese adults aged 18-60 years with overweight or obesity (BMI ≥ 24 kg/m² or central obesity: male waist circumference ≥ 90 cm, female ≥ 85 cm). Enrolled from 24 hospitals across China. Participants are classified into three groups: metabolically healthy overweight/obesity (MH-OW/OB), metabolically unhealthy overweight/obesity (MU-OW/OB), and type 2 diabetes with overweight/obesity (T2DM-OW/OB). All participants must be able to use a smartphone for daily communication and provide written informed consent. Key exclusions include type 1 diabetes, severe hepatic/renal impairment, uncontrolled hypertension or diabetes (HbA1c > 9.0%), active malignancy, pregnancy, and conditions interfering with follow-up or AI platform use.
Key inclusion criteria (4 listed)
- Able to understand and voluntarily sign the informed consent form, and willing to comply with all study requirements.
- Age between 18 and 60 years (inclusive).
- 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.
- Capable of basic smartphone operation and able to use WeChat or similar communication tools for daily communication.
Key exclusion criteria (17 listed)
- Diagnosis of type 1 diabetes, latent autoimmune diabetes in adults (LADA), maturity-onset diabetes of the young (MODY), or other specific types of diabetes.
- 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.
- Severe liver disease (Child-Pugh class B or C).
- Renal insufficiency (estimated glomerular filtration rate < 30 mL/min/1.73 m²).
- Severe cardiac dysfunction (New York Heart Association class III or IV).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Phenotype Transition Rate
Time frame: 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
Time frame: 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.
5 secondary outcomes
Longitudinal Changes in Metabolic Parameters
Time frame: Baseline, 2.5 years, 5 years
Diabetic Microvascular Complications
Time frame: Baseline, 2.5 years, 5 years
Major Adverse Cardiovascular Events
Time frame: Baseline, 2.5 years, 5 years
All-Cause Mortality
Time frame: Baseline, 2.5 years, 5 years
Cardiovascular Risk Comparison Across Phenotypes
Time frame: Baseline, 2.5 years, 5 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 27 Oct 2026.
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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.
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 Overweight and Obesity and Diabetes Mellitus, Type 2, run by Zhujiang 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 4 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 27 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 Hong Chen, Ph.D. (+86 20 61643888, rubychfq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenotype Transition Rate (time frame: Baseline, 2.5 years, 5 years). The study lists 2 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 27 Oct 2026.