Correlation Between Various Adipokines and Vascular Inflammation Measured by Positron Emission Tomography (PET) With 18F-fluoro-deoxyglucose (FDG) (18FDG-PET)

Atherosclerosis Clinical Trial

Official title:

Correlation Between Various Adipokines and Vascular Inflammation Measured by 18FDG-PET In Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150006
• Other study ID #: PET_Adipokines
• Status: Completed
• Phase: N/A
• First received: June 9, 2010
• Last updated: June 28, 2010
• Start date: April 2010
• Est. completion date: June 2010

Study information

• Verified date: April 2010
• Source: Korea University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The inflammatory state and composition of atherosclerotic plaques are considered the main contributing factors responsible for acute cardiovascular events, rather than the degree of stenosis. Recently, positron emission tomography (PET) with 18F-fluoro-deoxyglucose (FDG) has been suggested as a promising novel imaging technique to identify the inflammatory state of atherosclerotic plaque. Recently, a few clinical studies showed that circulating A-FABP level had a close relation with the development of atherosclerosis in human. Therefore, in the present study, the investigators examined the relationship between circulating A-FABP and vascular inflammation of carotid arteries measured using FDG-PET in healthy male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Healthy male volunteers for visiting routine medical check in our clinic

Exclusion Criteria:

• History of cardiovascular disease (myocardial infarction, unstable angina,stroke, or cardiovascular revascularization)

• Diabetes

• Hypertension

• Malignancy

• Severe renal or hepatic disease

• Subjects taking medications that might affect inflammation such as NSIAD and statin

Study Design

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

Related Conditions & MeSH terms

• Atherosclerosis
• Inflammation

Intervention

Other:
• Cross sectional study
This is not intervention study. The purpose of the study is to examine the relationship between various adipokine levels and PET imaging at the cross section setting

Locations

Country	Name	City	State
Korea, Republic of	Hye Jin Yoo	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	Vascular inflammation in carotid arterial wall, represented as the target-to-background ratio (TBR), using FDG-PET		12 weeks	No
Secondary	Circulating serum A-FABP levels		12 weeks	No
Secondary	Circulating serum leptin levels		12weeks	No
Secondary	Circulating serum adiponectin levels		12 weeks	No
Secondary	Carotid intima-media thickness levels measured using ultrasonography		12 weeks	No