NCT01150019

Brief Summary

Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis.Resistin was shown to induce vascular endothelial dysfunction and vascular smooth muscle cell proliferation. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.Therefore, the purpose of the study is to demonstrate the correlation between circulating resistin and vascular inflammation detected by 18FDG-PET in obese persons.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

Shorter than P25 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

April 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 24, 2010

Completed
Last Updated

July 8, 2010

Status Verified

April 1, 2010

Enrollment Period

2 months

First QC Date

June 9, 2010

Last Update Submit

July 7, 2010

Conditions

Keywords

atherosclerosisvascular inflammationresistinadiponectin18FDG-PET

Outcome Measures

Primary Outcomes (1)

  • Vascular inflammation in carotid arterial wall represented as the target-to-background ratio (TBR) using FDG-PET

    12 weeks

Secondary Outcomes (3)

  • Circulating serum adiponectin levels

    12 weeks

  • carotid intima-media thickness levels measured using ultrasonography

    12 weeks

  • Circulating serum resistin levels

    12 weeks

Study Arms (2)

Obese Group

Other: Cross sectional study

Non Obese Group

Other: Cross sectional study

Interventions

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

Non Obese GroupObese Group

Eligibility Criteria

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

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

You may qualify if:

  • Healthy volunteers 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
  • Hypertension
  • Malignancy
  • Severe renal or hepatic disease
  • Subjects taking medications that might affect inflammation such as non-steroidal anti-inflammatory drugs (NSAIDs) and statin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hae Yoon Choi

Seoul, 152-703, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, whole blood, serum

MeSH Terms

Conditions

Atherosclerosis

Interventions

Cross-Sectional Studies

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Kyung Mook Choi, MD.PhD

    Korea University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2010

First Posted

June 24, 2010

Study Start

April 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

July 8, 2010

Record last verified: 2010-04

Locations