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RecruitingNCT07043166Updated Sep 8, 2025

Cardiovascular-Kidney-Metabolic Syndrome in Shanghai Zicitizens

An observational study in Metabolic Syndrome, Diabetes and Obesity and Overweight, sponsored by Shanghai Changzheng Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-08.

Sponsored by Shanghai Changzheng Hospital · Observational

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,094
Ages
18 Years and older
Sex
All
01

Study 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 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).

02

Conditions studied

  • Metabolic Syndrome
  • Diabetes
  • Obesity and Overweight
  • Hypertension
  • Dyslipidemia
  • Thyroid Diseases
  • Bone Metabolism Disorder
  • Chronic Kidney Disease(CKD)
  • Cardiovascular Diseases (CVD)
  • Cardiovascular-kidney-metabolic Syndrome

Keywords

  • Cardiovascular-Kidney-Metabolic Syndrome
  • metabolic disorders
  • screening
  • risk factor
  • evaluation
  • prediction
03

In context

Metabolic Syndrome

2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.

This study's planned enrollment of 4,094 is above the median of 197 across 496 observational studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

Shanghai Changzheng Hospital is the lead sponsor of 128 studies on the registry; 60 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

A total of 4,094 residents were drawn from 10 communities in Shanghai, with baseline multidimensional data collected."

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

  1. The 4,094 residents of Shanghai communities who have been enrolled in the STONE cohort.
  2. Individuals who completed the baseline questionnaire survey, physical examination, and related clinical tests between 2016 and 2017, with complete data records.
  3. Willingness to participate in this follow-up study and provision of .

Exclusion criteria

Exclusion Criteria:

  1. Participants who have moved away from their original community and have been living elsewhere for more than two years.
  2. Participants whose contact information has changed or become invalid, resulting in loss of contact (those who remain uncontactable after three attempts to reach out).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,094 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Through study completion, an average of 10 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07043166
Responsible party
Tuo Li, MD (Deputy Director, Shanghai Changzheng Hospital) — Principal investigator
First posted
Jun 29, 2025
Start date
Jul 1, 2025
Primary completion
May 30, 2035 (estimated)
Completion
Dec 31, 2035 (estimated)
Last update
Sep 8, 2025

Study contacts

tuo Tuo Li, Doctor
Contact
dr.lituo@smmu.edu.cn
86-13918507887
tuo Li, Prof.
study director · Shanghai Changzheng Hospital

Oversight

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

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