- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05156580
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
Active, not recruiting
Conditions
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
-
-
Beijing Municipality
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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
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 |
Intervention / Treatment |
|---|---|
|
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).
|
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).
|
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).
|
This is an observational study without any intervention
|
|
Lean normotensive
Lean patients (BMI ≤ 24 kg/m2) diagnosed with normotensive (SBP/DBP < 140/90 mmHg).
|
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)
|
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).
|
This is an observational study without any intervention
|
What is the study measuring?
Primary Outcome Measures
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
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
Collaborators
Investigators
- 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)
July 1, 2016
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
November 24, 2021
First Submitted That Met QC Criteria
December 12, 2021
First Posted (Actual)
December 14, 2021
Study Record Updates
Last Update Posted (Estimated)
October 2, 2025
Last Update Submitted That Met QC Criteria
September 29, 2025
Last Verified
August 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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