Correlation Between NAFLD, Epicardial Adipose Tissue and Vascular Inflammation Measured by Positron Emission Tomography (PET) With 18F-fluoro-deoxyglucose (FDG)

Atherosclerosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01958411
• Other study ID #: PET(NAFLD, EAT)
• Status: Completed
• Phase: N/A
• First received: October 7, 2013
• Last updated: October 7, 2013
• Start date: December 2008

Study information

• Verified date: October 2013
• Source: Korea University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical 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.

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Atherosclerosis
• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between vascular inflammatory status measured by 18FDG PET and NAFLD measured by un-enhanced CT		12 weeks	No
Primary	Correlation between vascular inflammatory status measured by 18FDG PET and epicardial adipose tissue measured by CT		12 weeks	No
Secondary	The relationship of NAFLD with carotid intima media thickness		12 weeks	No
Secondary	The relationship of epicardial adipose tissue volume with carotid intima media thickness		12 weeks	No