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NCT Number: NCT07043166

Cardiovascular-Kidney-Metabolic Syndrome in Shanghai Zicitizens

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.

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Key information

Conditions

Metabolic Syndrome Body Weight Bone Diseases Bone Diseases, Metabolic Bone Metabolism Disorder Cardiovascular Diseases Cardiovascular Diseases (CVD) Cardiovascular-kidney-metabolic Syndrome Chronic Disease Chronic Kidney Disease(CKD) Diabetes Diabetes Mellitus Disease Attributes Dyslipidemia Dyslipidemias Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperinsulinism Hypertension Insulin Resistance Kidney Diseases Lipid Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity and Overweight Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Thyroid Diseases Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of Participants Who developed metabolic disorders.

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

    Metabolic disorders include obesity, dyslipidemia, diabetes, fatty liver diseases, hypertension, hyperuricemia, chronic kidney disease, thyroid diseases, and bone metabolism-related disorders.

Study contacts

Contact information is provided by the study sponsor or research team.

tuo Tuo Li, Doctor

CONTACT

[email protected]

86-13918507887

Sponsors and collaborators

Lead sponsor

Shanghai Changzheng Hospital

Other

Registry information

Official study title

Epidemiological Survey and Follow-up of Cardiovascular-Kidney-Metabolic Diseases Among Adults in Shanghai

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Jun 29, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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