NCT01958411

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
Last Updated

October 9, 2013

Status Verified

October 1, 2013

Enrollment Period

2.2 years

First QC Date

October 7, 2013

Last Update Submit

October 7, 2013

Conditions

Outcome Measures

Primary Outcomes (2)

  • Correlation between vascular inflammatory status measured by 18FDG PET and NAFLD measured by un-enhanced CT

    12 weeks

  • Correlation between vascular inflammatory status measured by 18FDG PET and epicardial adipose tissue measured by CT

    12 weeks

Secondary Outcomes (2)

  • The relationship of NAFLD with carotid intima media thickness

    12 weeks

  • The relationship of epicardial adipose tissue volume with carotid intima media thickness

    12 weeks

Study Arms (1)

18FDG-PET/CT

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy participants who underwent a medical health check in the health promotion center in Korea Guro University

You may qualify if:

  • Healthy patients for visiting routine medical check in our clinic

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Guro Hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

AtherosclerosisNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesFatty LiverLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 9, 2013

Study Start

December 1, 2008

Primary Completion

March 1, 2011

Last Updated

October 9, 2013

Record last verified: 2013-10

Locations