Current Status of Cardiovascular Diseases in Chinese Overweight/ Obesity Population: An Epidemiological Study (COPE） (COPE)

January 21, 2026 updated by: Novo Nordisk A/S
This study is testing how overweight and obesity affect cardiovascular disease (CVD) prevalence, risk factors, and mortality among Chinese adults using nationally representative CCDRFS (China Chronic Disease and Risk Factor Surveillance) data. The purpose of the study is to characterize trends and determinants of CVD in adults with overweight or obesity and to quantify the excess mortality and population burden attributable to overweight/obesity. Participants will not receive any study medicine as this is an observational analysis of existing survey and mortality data. The study does not involve a new investigational drug; it analyses health and outcome data collected in routine practice and national surveys. The study will last for the duration needed to analyse the CCDRFS datasets and linked mortality follow-up.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

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.
551931

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, China
        • Novonordisk Facility
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 102206
        • National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese CDC

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The subjects in this study are permanent residents aged 18 years and older who participated in the CCDRFS in 2013, 2018, and 2023. Eligible participants were permanent residents (residing ≥6 months) of the survey sites, which included 298 counties/districts across all 31 provinces, autonomous regions, and municipalities of mainland China.

Description

Inclusion Criteria:

  • Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
  • Male or female, age above or equal to 18 years at the time of signing informed consent.
  • Permanent residents (residing in the survey counties/cities/districts for ≥6 months) from the 2013, 2018, and 2023 CCDRFS surveys; With complete information from physical examinations, blood biochemical tests, and questionnaires, including:
  • Demographic information (age, sex, urban/rural classification, etc.);
  • Height, weight, waist circumference, blood pressure;
  • Blood biochemical indicators (fasting/2-hour postprandial blood glucose, glycated hemoglobin, lipid panel: high density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, total cholesterol, serum creatinine, etc.);
  • Routine urine indicators: urine protein (or urine microalbumin); self-reported prevalence of CVD and major chronic diseases (e.g., hypertension, diabetes, dyslipidemia, etc.);
  • Major behavioral risk factors (smoking, alcohol consumption, physical activity, dietary patterns, etc.);
  • Information on concomitant medication use.

Exclusion Criteria:

- Exclusion criteria include missing core baseline or follow-up data relevant to each part. The medical conditions under investigation include overweight and obesity, along with their comorbidity with CVD and associated risk factors.

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.
Part 1
Using CCDRFS data from 2013, 2018, and 2023, we will examine trends in CVD and key risk factors (hypertension, dyslipidemia, hyperglycemia, CKD) among overweight/obese adults, comparing prevalence by sex, urban/rural residence, and age to assess the impact of overweight/obesity on cardiovascular health for public health planning.
Other: No treatment given
No treatment given
Part 2
Using CCDRFS 2023 data, we will perform a cross-sectional analysis to identify CVD risk factors in overweight and obese Chinese adults. We will: (1) compare characteristics of overweight/obese individuals with and without CVD, and (2) compare CVD patients who are overweight/obese versus normal weight. Odds ratios will be estimated to assess associations between risk factors and CVD within the overweight/obese group and to compare these associations against the normal-weight group. Subgroup and sensitivity analyses will be conducted to examine heterogeneity and robustness.
Other: No treatment given
No treatment given
Part 3
We will link CCDRFS baseline data from 2013 and 2018 to the 2023 mortality follow-up database to estimate all-cause and cardiovascular mortality, population attributable fractions (PAF), and years of life lost (YLL) associated with overweight/obesity using Cox proportional hazards models.
Other: No treatment given
No treatment given

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
Primary End point
Time Frame: 2013-2023
Primary outcome: prevalence of cardiovascular disease (CVD), defined as the proportion of participants reporting a physician diagnosis or self-reported history of coronary heart disease, stroke, heart failure, or peripheral artery disease. We will summarize how common CVD and related conditions are in the study population. Categorical variables (e.g., overweight/obesity, central obesity, prior diagnoses) will be reported as counts and percentages. Continuous variables (e.g., BMI, waist circumference) will be reported as n, mean, and SD. For each survey year (2013, 2018, 2023) we will compute crude and age-standardized, population-weighted prevalence estimates. Trends over time will be assessed using Joinpoint regression to estimate the Average Annual Percent Change (AAPC) with 95% confidence intervals.
2013-2023

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.
Novo Nordisk A/S

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.
  • Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

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.
December 8, 2025

Primary Completion (Actual)

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.
December 12, 2025

Study Completion (Actual)

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.
December 12, 2025

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, 2025

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.
January 21, 2026

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.
January 22, 2026

Study Record Updates

Last Update Posted (Actual)

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.
January 22, 2026

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.
January 21, 2026

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.
January 1, 2026

More Information

Terms related to this study

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.
  • DAS-8633
  • U1111-1325-5282 (Other Identifier: World Health Organization ( WHO ))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

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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