Prevalence and Overlap of Cardiovascular, Kidney, and Metabolic Diseases in Korea: A Population-based Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 800,000
- 试验地点
- 1
- 主要终点
- Proportion of participants with obesity (BMI ≥25 kilograms per square meter (kg/m^2))
研究概览
简要总结
This study tests the prevalence and characteristics of overlapping obesity, type 2 diabetes (T2D), cardiovascular disease (CVD), chronic kidney disease (CKD), and metabolic dysfunction-associated steatotic liver disease [MASLD/Metabolic Dysfunction-Associated Steatohepatitis (MASH)], osteoarthritis, hypertension, and dyslipidemia. The purpose of the study is to measure how common cardiovascular, kidney, and metabolic diseases are in the Korean adult population and how often they occur together (overlap) over time (2013-2023). Participants will not receive any study medicine as this is an observational analysis of existing survey data. The study does not involve a new investigational drug; it analyses health and outcome data collected in routine practice and national surveys.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For an eligible participant, all inclusion criteria must be answered "yes".
- •Primary Analysis:
- •Enrolled in the Korean National Health Insurance Service (NHIS) with valid insurance eligibility during the assessment year.
- •Adults aged 19 years or older at the index date (January 1 of each assessment year, annually from 2013 to 2023).
- •Secondary Analysis (Subgroup Cohorts):
- •Enrolled in the Korean National Health Insurance Service (NHIS) with valid insurance eligibility during the cohort entry year.
- •Adults aged 19 years or older at the cohort entry date (i.e., the index date defined per the relevant subgroup cohort in) (per the SAP).
- •Meets the operational definition of the index disease or state for one of the four pre-specified subgroup cohorts (MASLD, HF, CKM stage, or High obesity) (per the SAP).
排除标准
- •For an eligible participant, all exclusion criteria must be answered "no".
- •Primary Analysis:
- •Individuals with missing age or sex information in the NHIS database.
- •Individuals with less than 1 year of continuous enrollment prior to the index date (to ensure adequate lookback period for disease identification).
- •Secondary Analysis (Subgroup Cohorts)
- •Individuals with missing age or sex information in the NHIS database.
- •Individuals with less than 1 year of continuous NHIS enrollment prior to the cohort entry date (to ensure adequate washout for incident-case ascertainment).
- •Individuals with prior record of respective disease within the 1-year lookback window
研究组 & 干预措施
MASLD
Participants with MASLD where the date of first MASLD identification at biennial screening (2013-2018), after the greater than or equal to (≥) 1-year washout window; follow-up continues until death, loss of NHIS eligibility, or end of available data.
干预措施: No treatment given (Other)
Heart Failure (HF)
Participants for whom the date of first HF diagnosis is at biennial screening (2013-2028), after the ≥1-year washout window; follow-up continues for a minimum of 5 years from the index date.
干预措施: No treatment given (Other)
CKM Stage
Participants were categorized according to CKM staging (Stages 0-4), based on their CKM stage assessed at the initial national health screening, after the ≥1-year washout window; follow-up continues until death, loss of National Health Insurance Service (NHIS) eligibility, or end of available data.
干预措施: No treatment given (Other)
High Obesity
Participants with pre-specified obesity participants of interest tier that indicating significant overweight and were classified into three categories: 1) Body Mass Index (BMI) greater than or equal to (≥) 27 kg/m^2 with established CVD. 2) BMI ≥27 kg/m^2 with one or more obesity-related comorbidities. 3) BMI ≥25 kg/m^2 and less than (<) 30 kg/m^2 with 1 or more obesity-related comorbidities.
干预措施: No treatment given (Other)
Atherosclerotic Cardiovascular Disease (ASCVD) with or without CKD
Participants with ASCVD where the first ASCVD identification occurred during biennial screening (2013-2018), after the ≥1-year washout window.
干预措施: No treatment given (Other)
结局指标
主要结局
Proportion of participants with obesity (BMI ≥25 kilograms per square meter (kg/m^2))
时间窗: 2013-2018 (Annually)
Measured in proportion (%).
Proportion of participants with T2D
时间窗: 2013-2018 (Annually)
Measured in proportion (%).
Proportion of participants with hypertension
时间窗: 2013-2018 (Annually)
Measured in proportion (%).
Proportion of participants with dyslipidemia
时间窗: 2013-2018 (Annually)
Measured in proportion (%).
Proportion of participants with CVD (ASCVD, HF with atrial fibrillation, HF without atrial fibrillation)
时间窗: 2013-2018 (Annually)
Measured in proportion (%).
Proportion of participants with CKD
时间窗: 2013-2018 (Annually)
Measured in proportion (%).
Proportion of participants with MASLD; at-risk Metabolic Dysfunction-Associated Steatohepatitis (MASH)(within MASLD)
时间窗: 2013-2018 (Annually)
Measured in proportion (%).
Proportion of participants with Osteoarthritis (OA)
时间窗: 2013-2018 (Annually)
Measured in proportion (%).
Multi-disease overlap (≥2, ≥3 conditions)
时间窗: 2013-2018 (Annually)
Measured in proportion (%).
Patient characteristics in obesity/diabetes-anchored strata
时间窗: 2013-2018 (Annually)
Measured as descriptive statistics.
次要结局
- Baseline characteristics by subgroup cohort(Cohort index date (2013-2018))
- All-cause mortality over cohort follow-up(From cohort index date (entry restricted to 2013-2018; ≥5 yr potential follow up (FU)))
- Healthcare resource utilization (HCRU) over cohort follow-up (Number of participants)(From cohort index date (entry restricted to 2013-2018; ≥5 yr potential FU))
- Healthcare resource utilization (HCRU) over cohort follow-up (rates per person-year)(From cohort index date (entry restricted to 2013-2018; ≥5 yr potential FU))
- Total medical costs over cohort follow-up (Mean)(From cohort index date (entry restricted to 2013-2018; ≥5 yr potential FU))
- Total medical costs over cohort follow-up (Median)(From cohort index date (entry restricted to 2013-2018; ≥5 yr potential FU))
- Three-point major adverse cardiovascular events (3P-MACE) composite assessment for CV-death proxy, non-fatal myocardial infarction, and non-fatal stroke(From cohort index date (entry restricted to 2013-2018; ≥5 yr potential (FU))
- Proportion of participants with baseline organ-axis phenotype distribution (HF cohort): ASCVD, renal, metabolic, hepatic axes(Cohort index date (2013-2018))
- Proportion of participants with GDMT prescription patterns, calendar-year trends, and prescription disparities (HF cohort)(Over cohort follow-up (2013-2023))
- Time to CKM stage progression (CKM stage cohort)(From cohort index date (entry restricted to 2013-2018; ≥5 years potential FU) to date of Progression)
- Time to tier change (High obesity cohort)(From cohort index date (entry restricted to 2013-2018; ≥5 years potential FU) to tier change)