Cardiovascular DiseaseNCT02640859
Investigation of Metabolic Risk in Korean Adults
An observational study of Cardiovascular Disease, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
A cohort study with Korean adults to investigate biomarkers in prediction of cardiometabolic and other diseases Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 1,003 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2015to 28 Feb 2019
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Korean Adults
Who may be able to join
- Healthy adults without chronic diseases
- Diabetic patients who are well controlled with oral antidiabetic agents
- Hypertensive patients who are well controlled with oral antihypertensive agents
- Dyslipidemic patients who are well controlled with oral lipid-lowering agents
Who cannot join
- Malignancy
- Chronic wasting disease
- Long-term steroid use
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
A cohort study with Korean adults to investigate biomarkers in prediction of cardiometabolic and other diseases
Read the detailed description
This is a prospective cohort study with Korean adults to investigate biomarkers in prediction of cardiometabolic and other diseases
- Conditions
- Cardiovascular Disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal cohort | Normal cohort for biobank |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cardiovascular disease
Measured: 5 years
Secondary outcomes (5)
Incidence of diabetes mellitus
Measured: 5 years
Incidence of fatty liver
Measured: 5 years
Incidence of metabolic syndrome
Measured: 5 years
Incidence of osteoporosis
Measured: 5 years
Incidence of sarcopenia
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startSep 2015
- Primary completion30 Nov 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Prospective
- Enrolment
- 1,003 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
- Investigators
- Soo Lim, MD, PhD, Principal investigator, SNUBH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640859
- Sponsor's protocol ID
- SNUBH-Biobank
- Status last verified
- Mar 2019
- First submitted
- 19 Dec 2015
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Metabolic Risk in Korean Adults
- ClinicalTrials.gov ID
- NCT02640859
- Acronym / sponsor ID
- SNUBH-Biobank
- Conditions
- Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,003 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 29 Dec 2015 (estimated)
- 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.
A cohort study with Korean adults to investigate biomarkers in prediction of cardiometabolic and other diseases
Detailed description
This is a prospective cohort study with Korean adults to investigate biomarkers in prediction of cardiometabolic and other diseases
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal cohort | – | –Normal cohort for biobank |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Korean Adults
Key inclusion criteria (4 listed)
- Healthy adults without chronic diseases
- Diabetic patients who are well controlled with oral antidiabetic agents
- Hypertensive patients who are well controlled with oral antihypertensive agents
- Dyslipidemic patients who are well controlled with oral lipid-lowering agents
Key exclusion criteria (3 listed)
- Malignancy
- Chronic wasting disease
- Long-term steroid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of cardiovascular disease
Time frame: 5 years
5 secondary outcomes
Incidence of diabetes mellitus
Time frame: 5 years
Incidence of fatty liver
Time frame: 5 years
Incidence of metabolic syndrome
Time frame: 5 years
Incidence of osteoporosis
Time frame: 5 years
Incidence of sarcopenia
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Soo Lim, MD, PhD principal investigator
SNUBH
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 Cardiovascular Disease, run by Seoul National University Bundang Hospital 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 15 Mar 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of cardiovascular disease (time frame: 5 years). 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 15 Mar 2019.