Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
Study NCT ID:
NCT01150006
Status:
COMPLETED
Last Update Posted:
2010-06-29
First Post:
2010-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Correlation Between Various Adipokines and Vascular Inflammation Measured by Positron Emission Tomography (PET) With 18F-fluoro-deoxyglucose (FDG) (18FDG-PET)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003430', 'term': 'Cross-Sectional Studies'}], 'ancestors': [{'id': 'D016021', 'term': 'Epidemiologic Studies'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'whole blood, plasma, serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-28', 'studyFirstSubmitDate': '2010-06-09', 'studyFirstSubmitQcDate': '2010-06-23', 'lastUpdatePostDateStruct': {'date': '2010-06-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vascular inflammation in carotid arterial wall, represented as the target-to-background ratio (TBR), using FDG-PET', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Circulating serum A-FABP levels', 'timeFrame': '12 weeks'}, {'measure': 'Circulating serum leptin levels', 'timeFrame': '12weeks'}, {'measure': 'Circulating serum adiponectin levels', 'timeFrame': '12 weeks'}, {'measure': 'Carotid intima-media thickness levels measured using ultrasonography', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['atherosclerosis', 'vascular inflammation', 'adipocyte fatty acid binding protein', 'adiponectin', 'leptin', '18FDG-PET'], 'conditions': ['Atherosclerosis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy male participats who underwent a medical health check in the health promotion center in Korea Guro University', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male volunteers for visiting routine medical check in our clinic\n\nExclusion Criteria:\n\n* History of cardiovascular disease (myocardial infarction, unstable angina,stroke, or cardiovascular revascularization)\n* Diabetes\n* Hypertension\n* Malignancy\n* Severe renal or hepatic disease\n* Subjects taking medications that might affect inflammation such as NSIAD and statin'}, 'identificationModule': {'nctId': 'NCT01150006', 'briefTitle': 'Correlation Between Various Adipokines and Vascular Inflammation Measured by Positron Emission Tomography (PET) With 18F-fluoro-deoxyglucose (FDG) (18FDG-PET)', 'organization': {'class': 'OTHER', 'fullName': 'Korea University'}, 'officialTitle': 'Correlation Between Various Adipokines and Vascular Inflammation Measured by 18FDG-PET In Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'PET_Adipokines'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy male participants', 'interventionNames': ['Other: Cross sectional study']}], 'interventions': [{'name': 'Cross sectional study', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Healthy male participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '152-703', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hye Jin Yoo', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyung Mook Choi, MD.PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Name/Official Title: Kyung Mook Choi', 'oldOrganization': 'Korea University'}}}}