Tongzhou Cohort Study

September 29, 2025 updated by: Beijing Friendship Hospital

Long-term Impact of Overweight/Obesity and Hypertension on Cardiovascular Risk in Middle-aged and Elderly Adults: A Cohort Study

Long-term Impact of Overweight/Obesity and Hypertension on Cardiovascular Risk in Middle-aged and Elderly Adults

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Overweight and obesity are major risk factors associated with the development of hypertension, poor blood pressure control, and adverse cardiovascular outcomes. However, evidence regarding the long-term impact of overweight/obesity and hypertension on cardiovascular risk in middle-aged and elderly populations remains limited. Therefore, the present study aims to evaluate the long-term effects of overweight/obesity and hypertension on cardiovascular risk in middle-aged and elderly adults.Additionally, a subgroup analysis will be conducted in participants with sarcopenia to assess the influence of blood pressure on prognosis, exploring potential interactions between muscle loss, hypertension, and cardiovascular outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31080

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100050
        • Beijing Friendship hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults undergoing routine physical examinations at community health service centers in Tongzhou, China.

Description

Inclusion Criteria:

  • Ages of ≥ 45 years
  • Participants from routine health examinations at Tongzhou Community Health Service Center
  • Availability for follow-up until 2026
  • No major barriers to provide written consent

Exclusion Criteria:

  • NA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Obese hypertensive group
Patients who were diagnosed with obesity (body mass index (BMI)≥28kg/m2) and hypertension (systolic blood pressure (SBP)/diastolic blood pressure (DBP) ≥ 140/90 mmHg).
Other: No intervention
This is an observational study without any intervention
Overweight hypertensive group
Overweight patients (24 kg/m2≤BMI≤28 kg/m2) diagnosed with hypertension (SBP/DBP≥140/90 mmHg).
Other: No intervention
This is an observational study without any intervention
Lean hypertensive group
Lean patients (BMI ≤ 24 kg/m2) diagnosed with hypertension (SBP/DBP ≥ 140/90 mmHg).
Other: No intervention
This is an observational study without any intervention
Lean normotensive
Lean patients (BMI ≤ 24 kg/m2) diagnosed with normotensive (SBP/DBP < 140/90 mmHg).
Other: No intervention
This is an observational study without any intervention
Overweight normotensive
Overweight patients (24 kg/m2≤BMI≤28 kg/m2) diagnosed with normotensive (SBP/DBP<140/90 mmHg)
Other: No intervention
This is an observational study without any intervention
Obese normotensive
Patients who were diagnosed with obesity (BMI≥28kg/m2) and normotensive (SBP/DBP<140/90 mmHg).
Other: No intervention
This is an observational study without any intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of participants with major adverse cardiovascular events (MACEs)
Time Frame: 2021-2026
Percentage of participants with major adverse cardiovascular events (MACEs), including all-cause death, nonfatal myocardial infarction (MI), nonfatal stroke and coronary revascularization.
2021-2026

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of participants with all-cause death
Time Frame: 2021-2026
Percentage of participants with cardiovascular, non-cardiovascular and undetermined death.
2021-2026
Percentage of participants with MI
Time Frame: 2021-2026
Percentage of participants with fatal and nonfatal MI.
2021-2026
Percentage of participants with stroke
Time Frame: 2021-2026
Percentage of participants with fatal and nonfatal stroke.
2021-2026
Percentage of participants undergoing coronary revascularization
Time Frame: 2021-2026
Percentage of participants undergoing ischemia- and non-ischemia-driven coronary revascularization.
2021-2026
Change in BP control rate
Time Frame: 2021-2026
Change in BP control rate (office BP: SBP < 140 mmHg and DBP < 90 mmHg) from baseline to follow-up.
2021-2026
Change in SBP
Time Frame: 2021-2026
Change in SBP from baseline to follow-up.
2021-2026
Change in estimated glomerular filtration rate (eGFR)
Time Frame: 2021-2026
Change in estimated glomerular filtration rate (eGFR) in ml/min/1.73m2 from baseline to follow-up.
2021-2026
Change in low-density lipoprotein-cholesterol (LDL-c)
Time Frame: 2021-2026
Change in low-density lipoprotein-cholesterol (LDL-c) in mmol/L from baseline to follow-up.
2021-2026
Percentage of participants with Metabolic dysfunction-associated steatotic liver disease (MASLD)
Time Frame: 2021-2026
Percentage of participants with Metabolic dysfunction-associated steatotic liver disease.
2021-2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Friendship Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing Tongzhou Yongshun Community Health Service
Beijing Tongzhou Lucheng Community Health Service
Beijing Tongzhou Xuxinzhuang Community Health Service

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rongchong Huang, M.D., Beijing Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-P2-163-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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