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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1337-3930 | Other Identifier | World Health Organization (WHO) |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Atherosclerotic Cardiovascular Disease (ASCVD) with or without CKD |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No treatment given | Other | No treatment given |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 (%). |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline characteristics by subgroup cohort | Measured as descriptive statistics. | Cohort index date (2013-2018) |
| All-cause mortality over cohort follow-up | Measured in Hazard Ratio (HR). |
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Inclusion Criteria:
Primary Analysis:
Secondary Analysis (Subgroup Cohorts):
Exclusion Criteria:
Primary Analysis:
Secondary Analysis (Subgroup Cohorts)
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Pharma Korea, Ltd. | Seoul | 01000 | South Korea |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Participants with ASCVD where the first ASCVD identification occurred during biennial screening (2013-2018), after the ≥1-year washout window. |
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| 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) |
| 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) | Measured as outpatient visits, hospitalizations, and emergency room visits in terms of 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) | Measured as outpatient visits, hospitalizations, and emergency room visits in terms of 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) | Measured as Cumulative total costs and annualized costs per person-year in terms of means with standard deviations. | From cohort index date (entry restricted to 2013-2018; ≥5 yr potential FU) |
| Total medical costs over cohort follow-up (Median) | Measured as Cumulative total costs and annualized costs per person-year in terms of medians with Interquartile Range (IQR) | 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 | Measured in Hazard Ratio (HR). | 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 | Measured in proportion (%) by phenotype. | Cohort index date (2013-2018) |
| Proportion of participants with GDMT prescription patterns, calendar-year trends, and prescription disparities (HF cohort) | Measured in proportion (%). | Over cohort follow-up (2013-2023) |
| Time to CKM stage progression (CKM stage cohort) | Measured as median time to progression, if estimable; number and proportion with progression | From cohort index date (entry restricted to 2013-2018; ≥5 years potential FU) to date of Progression |
| Time to tier change (High obesity cohort) | Measured as median time to tier change, if estimable; number and proportion with tier change. | From cohort index date (entry restricted to 2013-2018; ≥5 years potential FU) to tier change |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |