Diabetes Mellitus, Type 2NCT07673822
Prevalence and Overlap of Cardiovascular, Kidney, and Metabolic Diseases in Korea: A Population-based Study
An observational study of Diabetes Mellitus, Type 2 and Obesity, run by Novo Nordisk A/S at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity, Chronic Kidney Disease
- What is being tested?
- No treatment given
- How many people
- 800,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jun 2026to 3 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this 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.
- Being tested
- No treatment given
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
No treatment given
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with obesity (BMI ≥25 kilograms per square meter (kg/m^2))
Measured in proportion (%).
Measured: 2013-2018 (Annually)
Proportion of participants with T2D
Measured in proportion (%).
Measured: 2013-2018 (Annually)
Proportion of participants with hypertension
Measured in proportion (%).
Measured: 2013-2018 (Annually)
Proportion of participants with dyslipidemia
Measured in proportion (%).
Measured: 2013-2018 (Annually)
Proportion of participants with CVD (ASCVD, HF with atrial fibrillation, HF without atrial fibrillation)
Measured in proportion (%).
Measured: 2013-2018 (Annually)
Proportion of participants with CKD
Measured in proportion (%).
Measured: 2013-2018 (Annually)
Proportion of participants with MASLD; at-risk Metabolic Dysfunction-Associated Steatohepatitis (MASH)(within MASLD)
Measured in proportion (%).
Measured: 2013-2018 (Annually)
Proportion of participants with Osteoarthritis (OA)
Measured in proportion (%).
Measured: 2013-2018 (Annually)
Multi-disease overlap (≥2, ≥3 conditions)
Measured in proportion (%).
Measured: 2013-2018 (Annually)
Patient characteristics in obesity/diabetes-anchored strata
Measured as descriptive statistics.
Measured: 2013-2018 (Annually)
Secondary outcomes (11)
Baseline characteristics by subgroup cohort
Measured as descriptive statistics.
Measured: Cohort index date (2013-2018)
All-cause mortality over cohort follow-up
Measured in Hazard Ratio (HR).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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.
Measured: Cohort index date (2013-2018)
Proportion of participants with GDMT prescription patterns, calendar-year trends, and prescription disparities (HF cohort)
Measured in proportion (%).
Measured: 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
Measured: 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.
Measured: From cohort index date (entry restricted to 2013-2018; ≥5 years potential FU) to tier change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start8 Jun 2026
- Primary completion3 Aug 2026 (estimated)
- Study completion3 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 800,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673822
- Sponsor's protocol ID
- DAS-8867
- Other IDs
- U1111-1337-3930
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Overlap of Cardiovascular, Kidney, and Metabolic Diseases in Korea: A Population-based Study
- ClinicalTrials.gov ID
- NCT07673822
- Acronym / sponsor ID
- DAS-8867
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 800,000 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- 3 Aug 2026 (estimated)
- Study completion
- 3 Aug 2026 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MASLD | – | Other: No treatment givenParticipants 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. |
| Heart Failure (HF) | – | Other: No treatment givenParticipants 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. |
| CKM Stage | – | Other: No treatment givenParticipants 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. |
| High Obesity | – | Other: No treatment givenParticipants 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. |
| Atherosclerotic Cardiovascular Disease (ASCVD) with or without CKD | – | Other: No treatment givenParticipants with ASCVD where the first ASCVD identification occurred during biennial screening (2013-2018), after the ≥1-year washout window. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- For an eligible participant, all inclusion criteria must be answered "yes".
- 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).
- 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).
Key exclusion criteria (8 listed)
- For an eligible participant, all exclusion criteria must be answered "no".
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No treatment givenNo treatment given | Other | Atherosclerotic Cardiovascular Disease (ASCVD) with or without CKD, CKM Stage, Heart Failure (HF), High Obesity, MASLD |
Primary outcome
Proportion of participants with obesity (BMI ≥25 kilograms per square meter (kg/m^2))
Time frame: 2013-2018 (Annually)
Measured in proportion (%).
Proportion of participants with T2D
Time frame: 2013-2018 (Annually)
Measured in proportion (%).
Proportion of participants with hypertension
Time frame: 2013-2018 (Annually)
Measured in proportion (%).
Proportion of participants with dyslipidemia
Time frame: 2013-2018 (Annually)
Measured in proportion (%).
Proportion of participants with CVD (ASCVD, HF with atrial fibrillation, HF without atrial fibrillation)
Time frame: 2013-2018 (Annually)
Measured in proportion (%).
Proportion of participants with CKD
Time frame: 2013-2018 (Annually)
Measured in proportion (%).
Proportion of participants with MASLD; at-risk Metabolic Dysfunction-Associated Steatohepatitis (MASH)(within MASLD)
Time frame: 2013-2018 (Annually)
Measured in proportion (%).
Proportion of participants with Osteoarthritis (OA)
Time frame: 2013-2018 (Annually)
Measured in proportion (%).
Multi-disease overlap (≥2, ≥3 conditions)
Time frame: 2013-2018 (Annually)
Measured in proportion (%).
Patient characteristics in obesity/diabetes-anchored strata
Time frame: 2013-2018 (Annually)
Measured as descriptive statistics.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Obesity, run by Novo Nordisk A/S at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with obesity (BMI ≥25 kilograms per square meter (kg/m^2)) (time frame: 2013-2018 (Annually)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.