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

This study has been completed.
Sponsor:
Information provided by:
Korea University
ClinicalTrials.gov Identifier:
NCT01150006
First received: June 9, 2010
Last updated: June 28, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention
Atherosclerosis
Other: Cross sectional study

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Correlation Between Various Adipokines and Vascular Inflammation Measured by 18FDG-PET In Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Korea University:

Primary Outcome Measures:
  • Vascular inflammation in carotid arterial wall, represented as the target-to-background ratio (TBR), using FDG-PET [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Circulating serum A-FABP levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Circulating serum leptin levels [ Time Frame: 12weeks ] [ Designated as safety issue: No ]
  • Circulating serum adiponectin levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Carotid intima-media thickness levels measured using ultrasonography [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

whole blood, plasma, serum


Enrollment: 90
Study Start Date: April 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy male participants 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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150006

Locations
Korea, Republic of
Hye Jin Yoo
Seoul, Korea, Republic of, 152-703
Sponsors and Collaborators
Korea University
Investigators
Principal Investigator: Kyung Mook Choi, MD.PhD Korea University
  More Information

No publications provided

Responsible Party: Name/Official Title: Kyung Mook Choi, Korea University
ClinicalTrials.gov Identifier: NCT01150006     History of Changes
Other Study ID Numbers: PET_Adipokines
Study First Received: June 9, 2010
Last Updated: June 28, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by Korea University:
atherosclerosis
vascular inflammation
adipocyte fatty acid binding protein
adiponectin
leptin
18FDG-PET

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Inflammation
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014