Metabolic SyndromeNCT07043166
Cardiovascular-Kidney-Metabolic Syndrome in Shanghai Zicitizens
An observational study of Metabolic Syndrome and Diabetes, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
The main purpose of this study is to conduct follow-up assessments and update the cardiorenal outcomes among the STONE cohort that was established during 2016-2017. The secondary aim is to compare metabolic risk factors, metabolic disturbances, and clinically relevant metabolic outcomes between the follow-up period… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Diabetes, Obesity and Overweight
- How many people
- 4,094 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 Dec 2035
- How long will I take part?
- 10 Years
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 4,094 residents were drawn from 10 communities in Shanghai, with baseline multidimensional data collected."
Who may be able to join
- The 4,094 residents of Shanghai communities who have been enrolled in the STONE cohort.
- Individuals who completed the baseline questionnaire survey, physical examination, and related clinical tests between 2016 and 2017, with complete data records.
- Willingness to participate in this follow-up study and provision of informed consent.
Who cannot join
- Participants who have moved away from their original community and have been living elsewhere for more than two years.
- Participants whose contact information has changed or become invalid, resulting in loss of contact (those who remain uncontactable after three attempts to reach out).
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
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
Tuo Li, MD, +86-139198507887, zoe_leeto@hotmail.com
Xin-yi Cai, MD., +86-18396514027, sinny379725@smmu.edu.cn
About this study
Official title: Epidemiological Survey and Follow-up of Cardiovascular-Kidney-Metabolic Diseases Among Adults in Shanghai
The main purpose of this study is to conduct follow-up assessments and update the cardiorenal outcomes among the STONE cohort that was established during 2016-2017. The secondary aim is to compare metabolic risk factors, metabolic disturbances, and clinically relevant metabolic outcomes between the follow-up period and the baseline assessment. The exploratory goal is to examine the relationships between changes in risk factors and clinical outcomes in the participants.
The study is planned to begin in May 2025 and will finalize the data collection for the entire population by June 2026. During this time, participants will be categorized based on CKM staging. The follow-up phase will continue until 2035.
Read the detailed description
Between 2016 and 2017, Shanghai Changzheng Hospital conducted a random stratified sampling in 10 communities in Shanghai among individuals aged 18-65 years who had resided in the community for more than six months. Pregnant women, individuals with fractures, severe mental disorders or dementia, bedridden individuals, and those with hepatitis, tuberculosis, AIDS, other infectious diseases, severe liver or kidney dysfunction, and other serious life-threatening diseases were excluded. The Shanghai Thyroid autOimmuNity: an Epidemiological research (STONE) cohort was established. Trained physicians collected multidimensional baseline health data from more than 4,000 Shanghai community residents through questionnaires, structured interviews, physical examinations, and clinical tests. The data included demographic information (gender, age, education level, marital status, employment status, income level, etc.), lifestyle and psychological status (smoking history, alcohol consumption history, dietary habits, sleep, physical activity, etc.), physical examination indicators (height, weight, waist circumference, blood pressure), comprehensive metabolic indicators (complete blood count, liver and kidney function, thyroid function, glucose metabolism indicators, lipid metabolism indicators, tumor immunity, hormone levels), and ultrasound imaging data (abdominal ultrasound, thyroid ultrasound, carotid ultrasound, bone density).
- Conditions
- Metabolic Syndrome, Diabetes, Obesity and Overweight, Hypertension, Dyslipidemia, Thyroid Diseases
- Keywords
- Cardiovascular-Kidney-Metabolic Syndrome, metabolic disorders, screening, risk factor, evaluation, prediction
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Obesity, Overweight, Hypertension, Dyslipidemias, Thyroid Diseases, Bone Diseases, Metabolic
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who developed cardiovascular diseases.
The diagnosis of cardiovascular diseases should be made according to the outcomes of carotid ultrasound and cardiac biomarkers.
Measured: Through study completion, an average of 10 year
Secondary outcomes (1)
Number of Participants Who developed metabolic disorders.
Metabolic disorders include obesity, dyslipidemia, diabetes, fatty liver diseases, hypertension, hyperuricemia, chronic kidney disease, thyroid diseases, and bone metabolism-related disorders.
Measured: Through study completion, an average of 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Jul 2025
- Primary completion30 May 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng 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
- 4,094 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuo Li, MD, Shanghai Changzheng Hospital
- Investigators
- tuo Li, Prof., Study director, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043166
- Sponsor's protocol ID
- STONE
- Status last verified
- Aug 2025
- First submitted
- 14 Jun 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Survey and Follow-up of Cardiovascular-Kidney-Metabolic Diseases Among Adults in Shanghai
- ClinicalTrials.gov ID
- NCT07043166
- Acronym / sponsor ID
- STONE
- Conditions
- Metabolic Syndrome, Diabetes, Obesity and Overweight, Hypertension, Dyslipidemia, Thyroid Diseases
- Keywords
- Cardiovascular-Kidney-Metabolic Syndrome, metabolic disorders, screening, risk factor, evaluation, prediction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,094 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 May 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 29 Jun 2025 (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 main purpose of this study is to conduct follow-up assessments and update the cardiorenal outcomes among the STONE cohort that was established during 2016-2017. The secondary aim is to compare metabolic risk factors, metabolic disturbances, and clinically relevant metabolic outcomes between the follow-up period and the baseline assessment. The exploratory goal is to examine the relationships between changes in risk factors and clinical outcomes in the participants.
The study is planned to begin in May 2025 and will finalize the data collection for the entire population by June 2026. During this time, participants will be categorized based on CKM staging. The follow-up phase will continue until 2035.
Detailed description
Between 2016 and 2017, Shanghai Changzheng Hospital conducted a random stratified sampling in 10 communities in Shanghai among individuals aged 18-65 years who had resided in the community for more than six months. Pregnant women, individuals with fractures, severe mental disorders or dementia, bedridden individuals, and those with hepatitis, tuberculosis, AIDS, other infectious diseases, severe liver or kidney dysfunction, and other serious life-threatening diseases were excluded. The Shanghai Thyroid autOimmuNity: an Epidemiological research (STONE) cohort was established. Trained physicians collected multidimensional baseline health data from more than 4,000 Shanghai community residents through questionnaires, structured interviews, physical examinations, and clinical tests. The data included demographic information (gender, age, education level, marital status, employment status, income level, etc.), lifestyle and psychological status (smoking history, alcohol consumption history, dietary habits, sleep, physical activity, etc.), physical examination indicators (height, weight, waist circumference, blood pressure), comprehensive metabolic indicators (complete blood count, liver and kidney function, thyroid function, glucose metabolism indicators, lipid metabolism indicators, tumor immunity, hormone levels), and ultrasound imaging data (abdominal ultrasound, thyroid ultrasound, carotid ultrasound, bone density).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 4,094 residents were drawn from 10 communities in Shanghai, with baseline multidimensional data collected."
Key inclusion criteria (3 listed)
- The 4,094 residents of Shanghai communities who have been enrolled in the STONE cohort.
- Individuals who completed the baseline questionnaire survey, physical examination, and related clinical tests between 2016 and 2017, with complete data records.
- Willingness to participate in this follow-up study and provision of informed consent.
Key exclusion criteria (2 listed)
- Participants who have moved away from their original community and have been living elsewhere for more than two years.
- Participants whose contact information has changed or become invalid, resulting in loss of contact (those who remain uncontactable after three attempts to reach out).
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
Number of Participants Who developed cardiovascular diseases.
Time frame: Through study completion, an average of 10 year
The diagnosis of cardiovascular diseases should be made according to the outcomes of carotid ultrasound and cardiac biomarkers.
1 secondary outcome
Number of Participants Who developed metabolic disorders.
Time frame: Through study completion, an average of 10 year
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 8 Sep 2025.
- Individual participant dataSharing planned: No
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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.
tuo Li, Prof. study director
Shanghai Changzheng 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 Metabolic Syndrome and Diabetes, run by Shanghai Changzheng 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 3 inclusion and 2 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 8 Sep 2025. 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 tuo Tuo Li, Doctor (86-13918507887, dr.lituo@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who developed cardiovascular diseases. (time frame: Through study completion, an average of 10 year). 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 8 Sep 2025.