AtherosclerosisNCT01958411
Correlation Between NAFLD, Epicardial Adipose Tissue and Vascular Inflammation Measured by Positron Emission Tomography (PET) With 18F-fluoro-deoxyglucose (FDG)
An observational study of Atherosclerosis and Non-alcoholic Fatty Liver Disease, run by Korea University at 1 site in South Korea.
Trial summary
Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Non-alcoholic Fatty Liver Disease
- How many people
- 340 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2008to Mar 2011
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy participants who underwent a medical health check in the health promotion center in Korea Guro University
Who may be able to join
- Healthy patients for visiting routine medical check in our clinic
Who cannot join
- History of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
- Diabetes
- Stage 2 hypertension (resting blood pressure, ≥ 160/100 mmHg)
- Malignancy
- Severe renal or hepatic disease
- Subjects taking medications that might affect inflammation such as nonsteroidal antiinflammatory drug and statin
Trial locations and contacts
1 site in 1 country.
About this study
- Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.
- Non-alcoholic fatty liver disease (NAFLD) is closely associated with many cardiometabolic risk factors. NAFLD can be detected by measuring liver fat accumulation using computed tomography (CT).
- Also epicardial adipose tissue (EAT) volume as determined by computed tomography (CT) is an independent marker of cardiovascular events in the general population.
- Therefore, the purpose of this investigators study is to compare the NAFLD severity and EAT volume with FDG uptake measured by PET/CT.
- Conditions
- Atherosclerosis, Non-alcoholic Fatty Liver Disease
- Medical subject headings
- Atherosclerosis, Non-alcoholic Fatty Liver Disease
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 |
|---|---|---|
| 18FDG-PET/CT | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between vascular inflammatory status measured by 18FDG PET and NAFLD measured by un-enhanced CT
Measured: 12 weeks
Correlation between vascular inflammatory status measured by 18FDG PET and epicardial adipose tissue measured by CT
Measured: 12 weeks
Secondary outcomes (2)
The relationship of NAFLD with carotid intima media thickness
Measured: 12 weeks
The relationship of epicardial adipose tissue volume with carotid intima media thickness
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startDec 2008
- Primary completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, K. M. Choi, Korea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958411
- Sponsor's protocol ID
- PET(NAFLD, EAT)
- Status last verified
- Oct 2013
- First submitted
- 7 Oct 2013
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee HJ, Lee CH, Kim S, Hwang SY, Hong HC, Choi HY, Chung HS, Yoo HJ, Seo JA, Kim SG, Kim NH, Baik SH, Choi DS, Choi KM. Association between vascular inflammation and non-alcoholic fatty liver disease: Analysis by 18F-fluorodeoxyglucose positron emission tomography. Metabolism. 2017 Feb;67:72-79. doi: 10.1016/j.metabol.2016.11.004. Epub 2016 Nov 6.
PubMed 28081780
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between NAFLD, Epicardial Adipose Tissue and Vascular Inflammation Measured by Positron Emission Tomography (PET) With 18F-fluoro-deoxyglucose (FDG)
- ClinicalTrials.gov ID
- NCT01958411
- Acronym / sponsor ID
- PET(NAFLD, EAT)
- Conditions
- Atherosclerosis, Non-alcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Mar 2011 (actual)
- First posted
- 9 Oct 2013 (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.
- Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.
- Non-alcoholic fatty liver disease (NAFLD) is closely associated with many cardiometabolic risk factors. NAFLD can be detected by measuring liver fat accumulation using computed tomography (CT).
- Also epicardial adipose tissue (EAT) volume as determined by computed tomography (CT) is an independent marker of cardiovascular events in the general population.
- Therefore, the purpose of this investigators study is to compare the NAFLD severity and EAT volume with FDG uptake measured by PET/CT.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18FDG-PET/CT | – | – |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy participants who underwent a medical health check in the health promotion center in Korea Guro University
Key inclusion criteria (1 listed)
- Healthy patients for visiting routine medical check in our clinic
Key exclusion criteria (6 listed)
- History of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
- Diabetes
- Stage 2 hypertension (resting blood pressure, ≥ 160/100 mmHg)
- Malignancy
- Severe renal or hepatic disease
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
Correlation between vascular inflammatory status measured by 18FDG PET and NAFLD measured by un-enhanced CT
Time frame: 12 weeks
Correlation between vascular inflammatory status measured by 18FDG PET and epicardial adipose tissue measured by CT
Time frame: 12 weeks
2 secondary outcomes
The relationship of NAFLD with carotid intima media thickness
Time frame: 12 weeks
The relationship of epicardial adipose tissue volume with carotid intima media thickness
Time frame: 12 weeks
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 9 Oct 2013.
- Derived from this study: PubMed 28081780Lee HJ, Lee CH, Kim S, Hwang SY, Hong HC, Choi HY, Chung HS, Yoo HJ, Seo JA, Kim SG, Kim NH, Baik SH, Choi DS, Choi KM. Association between vascular inflammation and non-alcoholic fatty liver disease: Analysis by 18F-fluorodeoxyglucose positron emission tomography. Metabolism. 2017 Feb;67:72-79. doi: 10.1016/j.metabol.2016.11.004. Epub 2016 Nov 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Atherosclerosis and Non-alcoholic Fatty Liver Disease, run by Korea University 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 1 inclusion and 6 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 9 Oct 2013. 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?
Correlation between vascular inflammatory status measured by 18FDG PET and NAFLD measured by un-enhanced CT (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01958411, which also lists 1 linked publication.
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 9 Oct 2013.