- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07358052
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
Study Type
Observational
Enrollment (Actual)
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
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Beijing, China
- Novonordisk Facility
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Beijing Municipality
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Beijing, Beijing Municipality, China, 102206
- National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese CDC
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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
- 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 |
Intervention / Treatment |
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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.
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No treatment given
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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.
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No treatment given
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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.
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No treatment given
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Primary End point
Time Frame: 2013-2023
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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.
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2013-2023
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
December 8, 2025
Primary Completion (Actual)
December 12, 2025
Study Completion (Actual)
December 12, 2025
Study Registration Dates
First Submitted
November 24, 2025
First Submitted That Met QC Criteria
January 21, 2026
First Posted (Actual)
January 22, 2026
Study Record Updates
Last Update Posted (Actual)
January 22, 2026
Last Update Submitted That Met QC Criteria
January 21, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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