- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01958411
Correlation Between NAFLD, Epicardial Adipose Tissue and Vascular Inflammation Measured by Positron Emission Tomography (PET) With 18F-fluoro-deoxyglucose (FDG)
October 7, 2013 updated by: K. M. Choi, Korea University
- 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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
340
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Korea University Guro Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy participants who underwent a medical health check in the health promotion center in Korea Guro University
Description
Inclusion Criteria:
- Healthy patients for visiting routine medical check in our clinic
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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18FDG-PET/CT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation between vascular inflammatory status measured by 18FDG PET and NAFLD measured by un-enhanced CT
Time Frame: 12 weeks
|
12 weeks
|
Correlation between vascular inflammatory status measured by 18FDG PET and epicardial adipose tissue measured by CT
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The relationship of NAFLD with carotid intima media thickness
Time Frame: 12 weeks
|
12 weeks
|
The relationship of epicardial adipose tissue volume with carotid intima media thickness
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
October 7, 2013
First Submitted That Met QC Criteria
October 7, 2013
First Posted (Estimate)
October 9, 2013
Study Record Updates
Last Update Posted (Estimate)
October 9, 2013
Last Update Submitted That Met QC Criteria
October 7, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PET(NAFLD, EAT)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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