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

NCT07673822 | Enrolling By Invitation

• 2 other identifiers: DAS-8867U1111-1337-3930
• Study Type: observational
• Target: 800,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2; Obesity; Chronic Kidney Disease; Cardiovascular Risk

Outcome Measures

Primary Outcomes (10)

• Proportion of participants with obesity (BMI ≥25 kilograms per square meter (kg/m^2))

  Measured in proportion (%).

  2013-2018 (Annually)

• Proportion of participants with T2D

  Measured in proportion (%).

  2013-2018 (Annually)

• Proportion of participants with hypertension

  Measured in proportion (%).

  2013-2018 (Annually)

• Proportion of participants with dyslipidemia

  Measured in proportion (%).

  2013-2018 (Annually)

• Proportion of participants with CVD (ASCVD, HF with atrial fibrillation, HF without atrial fibrillation)

  Measured in proportion (%).

  2013-2018 (Annually)

• Proportion of participants with CKD

  Measured in proportion (%).

  2013-2018 (Annually)

• Proportion of participants with MASLD; at-risk Metabolic Dysfunction-Associated Steatohepatitis (MASH)(within MASLD)

  Measured in proportion (%).

  2013-2018 (Annually)

• Proportion of participants with Osteoarthritis (OA)

  Measured in proportion (%).

  2013-2018 (Annually)

• Multi-disease overlap (≥2, ≥3 conditions)

  Measured in proportion (%).

  2013-2018 (Annually)

• Patient characteristics in obesity/diabetes-anchored strata

  Measured as descriptive statistics.

  2013-2018 (Annually)

Secondary Outcomes (11)

• 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)

Study Arms (5)

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.

Other: No treatment given

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.

Other: No treatment given

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.

Other: No treatment given

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.

Other: No treatment given

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.

Other: No treatment given

Interventions

No treatment given OTHER

No treatment given

Atherosclerotic Cardiovascular Disease (ASCVD) with or without CKD; CKM Stage; Heart Failure (HF); High Obesity; MASLD

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants in this study are drawn from Korean National Health Insurance Service (NHIS) - National Sample Cohort (NSC) aged 19 years and older. The eligible participants were selected by stratified random sampling in 2006 with follow-up through December 2023.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Pharma Korea, Ltd.

Seoul, 01000, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 29, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): August 3, 2026
• Study Completion (Estimated): August 3, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-06

Locations

KR (1)