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Enrolling by invitation NCT07673822

Prevalence and Overlap of Cardiovascular, Kidney, and Metabolic Diseases in Korea: A Population-based Study

— Observational Diabetes Mellitus, Type 2 Obesity Chronic Kidney Disease Cardiovascular Risk

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No treatment given.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 2, Obesity, Chronic Kidney Disease, Cardiovascular Risk. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other No treatment given
    No treatment given

Primary outcome measures

  • Proportion of participants with obesity (BMI ≥25 kilograms per square meter (kg/m^2)) [Time frame: 2013-2018 (Annually)]
  • Proportion of participants with T2D [Time frame: 2013-2018 (Annually)]
  • Proportion of participants with hypertension [Time frame: 2013-2018 (Annually)]
  • Proportion of participants with dyslipidemia [Time frame: 2013-2018 (Annually)]
  • Proportion of participants with CVD (ASCVD, HF with atrial fibrillation, HF without atrial fibrillation) [Time frame: 2013-2018 (Annually)]
  • Proportion of participants with CKD [Time frame: 2013-2018 (Annually)]
  • Proportion of participants with MASLD; at-risk Metabolic Dysfunction-Associated Steatohepatitis (MASH)(within MASLD) [Time frame: 2013-2018 (Annually)]
  • Proportion of participants with Osteoarthritis (OA) [Time frame: 2013-2018 (Annually)]
  • Multi-disease overlap (≥2, ≥3 conditions) [Time frame: 2013-2018 (Annually)]
  • Patient characteristics in obesity/diabetes-anchored strata [Time frame: 2013-2018 (Annually)]
Secondary outcome measures (11)
  • Baseline characteristics by subgroup cohort [Time frame: Cohort index date (2013-2018)]
  • All-cause mortality over cohort follow-up [Time frame: 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) [Time frame: 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) [Time frame: From cohort index date (entry restricted to 2013-2018; ≥5 yr potential FU)]
  • Total medical costs over cohort follow-up (Mean) [Time frame: From cohort index date (entry restricted to 2013-2018; ≥5 yr potential FU)]
  • Total medical costs over cohort follow-up (Median) [Time frame: 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 [Time frame: 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 [Time frame: Cohort index date (2013-2018)]
  • Proportion of participants with GDMT prescription patterns, calendar-year trends, and prescription disparities (HF cohort) [Time frame: Over cohort follow-up (2013-2023)]
  • Time to CKM stage progression (CKM stage cohort) [Time frame: From cohort index date (entry restricted to 2013-2018; ≥5 years potential FU) to date of Progression]
  • Time to tier change (High obesity cohort) [Time frame: From cohort index date (entry restricted to 2013-2018; ≥5 years potential FU) to tier change]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Novo Nordisk Pharma Korea, Ltd. — Seoul

Identifiers

NCT: NCT07673822 · DAS-8867 · U1111-1337-3930

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗