Cardiovascular Risk, Chronic Kidney Disease, Diabetes Mellitus, Type 2, Obesity
Conditions
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.
Interventions
OTHERNo treatment given
No treatment given
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Inclusion criteria
* For an eligible participant, all inclusion criteria must be answered "yes". Primary Analysis: 1. Enrolled in the Korean National Health Insurance Service (NHIS) with valid insurance eligibility during the assessment year. 2. 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): 1. Enrolled in the Korean National Health Insurance Service (NHIS) with valid insurance eligibility during the cohort entry year. 2. 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). 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with obesity (BMI ≥25 kilograms per square meter (kg/m^2)) | 2013-2018 (Annually) | Measured in proportion (%). |
| Proportion of participants with T2D | 2013-2018 (Annually) | Measured in proportion (%). |
| Proportion of participants with hypertension | 2013-2018 (Annually) | Measured in proportion (%). |
| Proportion of participants with dyslipidemia | 2013-2018 (Annually) | Measured in proportion (%). |
| Proportion of participants with CVD (ASCVD, HF with atrial fibrillation, HF without atrial fibrillation) | 2013-2018 (Annually) | Measured in proportion (%). |
| Proportion of participants with CKD | 2013-2018 (Annually) | Measured in proportion (%). |
| Proportion of participants with MASLD; at-risk Metabolic Dysfunction-Associated Steatohepatitis (MASH)(within MASLD) | 2013-2018 (Annually) | Measured in proportion (%). |
| Proportion of participants with Osteoarthritis (OA) | 2013-2018 (Annually) | Measured in proportion (%). |
| Multi-disease overlap (≥2, ≥3 conditions) | 2013-2018 (Annually) | Measured in proportion (%). |
| Patient characteristics in obesity/diabetes-anchored strata | 2013-2018 (Annually) | Measured as descriptive statistics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline characteristics by subgroup cohort | Cohort index date (2013-2018) | Measured as descriptive statistics. |
| All-cause mortality over cohort follow-up | From cohort index date (entry restricted to 2013-2018; ≥5 yr potential follow up (FU)) | Measured in Hazard Ratio (HR). |
| Healthcare resource utilization (HCRU) over cohort follow-up (Number of participants) | 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. |
| 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) | Measured as outpatient visits, hospitalizations, and emergency room visits in terms of rates per person-year. |
| Total medical costs over cohort follow-up (Mean) | 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. |
| Total medical costs over cohort follow-up (Median) | 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) |
| 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) | Measured in Hazard Ratio (HR). |
| Proportion of participants with baseline organ-axis phenotype distribution (HF cohort): ASCVD, renal, metabolic, hepatic axes | Cohort index date (2013-2018) | Measured in proportion (%) by phenotype. |
| Proportion of participants with GDMT prescription patterns, calendar-year trends, and prescription disparities (HF cohort) | Over cohort follow-up (2013-2023) | Measured in proportion (%). |
| 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 | Measured as median time to progression, if estimable; number and proportion with progression |
| Time to tier change (High obesity cohort) | 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. |
Countries
South Korea
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed