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OpenTrials
Enrolling by Invitation

NCT Number: NCT07673822

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

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.

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No treatment given

Other

No treatment given

Primary outcomes

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

    Time frame: 2013-2018 (Annually)

    Measured in proportion (%).

  2. Proportion of participants with T2D

    Time frame: 2013-2018 (Annually)

    Measured in proportion (%).

  3. Proportion of participants with hypertension

    Time frame: 2013-2018 (Annually)

    Measured in proportion (%).

  4. Proportion of participants with dyslipidemia

    Time frame: 2013-2018 (Annually)

    Measured in proportion (%).

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

    Time frame: 2013-2018 (Annually)

    Measured in proportion (%).

  6. Proportion of participants with CKD

    Time frame: 2013-2018 (Annually)

    Measured in proportion (%).

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

    Time frame: 2013-2018 (Annually)

    Measured in proportion (%).

  8. Proportion of participants with Osteoarthritis (OA)

    Time frame: 2013-2018 (Annually)

    Measured in proportion (%).

  9. Multi-disease overlap (≥2, ≥3 conditions)

    Time frame: 2013-2018 (Annually)

    Measured in proportion (%).

  10. Patient characteristics in obesity/diabetes-anchored strata

    Time frame: 2013-2018 (Annually)

    Measured as descriptive statistics.

Secondary outcomes

  1. Baseline characteristics by subgroup cohort

    Time frame: Cohort index date (2013-2018)

    Measured as descriptive statistics.

  2. All-cause mortality over cohort follow-up

    Time frame: From cohort index date (entry restricted to 2013-2018; ≥5 yr potential follow up (FU))

    Measured in Hazard Ratio (HR).

  3. 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)

    Measured as outpatient visits, hospitalizations, and emergency room visits in terms of number of participants.

  4. 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)

    Measured as outpatient visits, hospitalizations, and emergency room visits in terms of rates per person-year.

  5. Total medical costs over cohort follow-up (Mean)

    Time frame: From cohort index date (entry restricted to 2013-2018; ≥5 yr potential FU)

    Measured as Cumulative total costs and annualized costs per person-year in terms of means with standard deviations.

  6. Total medical costs over cohort follow-up (Median)

    Time frame: From cohort index date (entry restricted to 2013-2018; ≥5 yr potential FU)

    Measured as Cumulative total costs and annualized costs per person-year in terms of medians with Interquartile Range (IQR)

  7. 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)

    Measured in Hazard Ratio (HR).

  8. Proportion of participants with baseline organ-axis phenotype distribution (HF cohort): ASCVD, renal, metabolic, hepatic axes

    Time frame: Cohort index date (2013-2018)

    Measured in proportion (%) by phenotype.

  9. Proportion of participants with GDMT prescription patterns, calendar-year trends, and prescription disparities (HF cohort)

    Time frame: Over cohort follow-up (2013-2023)

    Measured in proportion (%).

  10. 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

    Measured as median time to progression, if estimable; number and proportion with progression

  11. 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

    Measured as median time to tier change, if estimable; number and proportion with tier change.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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