NCT07043166

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,094

participants targeted

Target at P75+ for all trials

Timeline
118mo left

Started Jul 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Jul 2025Dec 2035

First Submitted

Initial submission to the registry

June 14, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2035

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

9.9 years

First QC Date

June 14, 2025

Last Update Submit

August 31, 2025

Conditions

Keywords

Cardiovascular-Kidney-Metabolic Syndromemetabolic disordersscreeningrisk factorevaluationprediction

Outcome Measures

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.

    Through study completion, an average of 10 year

Secondary Outcomes (1)

  • Number of Participants Who developed metabolic disorders.

    Through study completion, an average of 10 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples will be collected at every visit

MeSH Terms

Conditions

Metabolic SyndromeDiabetes MellitusObesityOverweightHypertensionDyslipidemiasThyroid DiseasesBone Diseases, MetabolicRenal Insufficiency, ChronicCardiovascular DiseasesMetabolic Diseases

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesLipid Metabolism DisordersBone DiseasesMusculoskeletal DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic Processes

Study Officials

  • tuo Li, Prof.

    Shanghai Changzheng Hospital

    STUDY DIRECTOR

Central Study Contacts

tuo Tuo Li, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director

Study Record Dates

First Submitted

June 14, 2025

First Posted

June 29, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

May 30, 2035

Study Completion (Estimated)

December 31, 2035

Last Updated

September 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations