Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT02640859
Status:
COMPLETED
Last Update Posted:
2019-03-15
First Post:
2015-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Metabolic Risk in Korean Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'For measuring biomarkers'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1003}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-14', 'studyFirstSubmitDate': '2015-12-19', 'studyFirstSubmitQcDate': '2015-12-22', 'lastUpdatePostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of cardiovascular disease', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Incidence of diabetes mellitus', 'timeFrame': '5 years'}, {'measure': 'Incidence of fatty liver', 'timeFrame': '5 years'}, {'measure': 'Incidence of metabolic syndrome', 'timeFrame': '5 years'}, {'measure': 'Incidence of osteoporosis', 'timeFrame': '5 years'}, {'measure': 'Incidence of sarcopenia', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'A cohort study with Korean adults to investigate biomarkers in prediction of cardiometabolic and other diseases', 'detailedDescription': 'This is a prospective cohort study with Korean adults to investigate biomarkers in prediction of cardiometabolic and other diseases'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy Korean Adults', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults without chronic diseases\n* Diabetic patients who are well controlled with oral antidiabetic agents\n* Hypertensive patients who are well controlled with oral antihypertensive agents\n* Dyslipidemic patients who are well controlled with oral lipid-lowering agents\n\nExclusion Criteria:\n\n* Malignancy\n* Chronic wasting disease\n* Long-term steroid use'}, 'identificationModule': {'nctId': 'NCT02640859', 'briefTitle': 'Investigation of Metabolic Risk in Korean Adults', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Investigation of Metabolic Risk in Korean Adults', 'orgStudyIdInfo': {'id': 'SNUBH-Biobank'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal cohort', 'description': 'Normal cohort for biobank'}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Soo Lim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SNUBH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Soo Lim', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}