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

Novo Nordisk

Status: Completed

Conditions: Overweight; Obesity

Treatments: Other: No treatment given

Study type: Observational

Funder types: Industry

Identifiers

NCT07358052

DAS-8633

U1111-1325-5282 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 551,931 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

551,931 participants in 3 patient groups

Part 1

Description:

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.

Treatment:

Other: No treatment given

Part 2

Description:

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.

Treatment:

Other: No treatment given

Part 3

Description:

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.

Treatment:

Other: No treatment given