Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-02-12 @ 10:23 AM
Study NCT ID:
NCT01660932
Status:
COMPLETED
Last Update Posted:
2014-11-04
First Post:
2012-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vascular and Metabolic Effects of Omega-3 Fatty Acids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015228', 'term': 'Hypertriglyceridemia'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-01', 'studyFirstSubmitDate': '2012-08-08', 'studyFirstSubmitQcDate': '2012-08-08', 'lastUpdatePostDateStruct': {'date': '2014-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'flow-mediated dilation', 'timeFrame': '8 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'insulin resistance', 'timeFrame': '8 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['insulin resistance'], 'conditions': ['Hypertriglyceridemia']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that omega does-dependently improves vascular and insulin resistance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hypertriglyceridemia\n\nExclusion Criteria:\n\n* overt liver disease, chronic renal failure, hypothyroidism, myopathy, uncontrolled diabetes (HbA1c \\> 9%), severe hypertension, stroke, acute coronary events, coronary revascularization within the preceding 3 months, or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT01660932', 'briefTitle': 'Vascular and Metabolic Effects of Omega-3 Fatty Acids', 'organization': {'class': 'OTHER', 'fullName': 'Gachon University Gil Medical Center'}, 'orgStudyIdInfo': {'id': 'GMC-201103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'omega 1', 'description': 'omega 1 gm', 'interventionNames': ['Drug: omega']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'omega 2', 'description': 'omega 2 gm', 'interventionNames': ['Drug: omega']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'omega 4', 'description': 'omega 4 gm', 'interventionNames': ['Drug: omega']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['placebo']}, {'name': 'omega', 'type': 'DRUG', 'armGroupLabels': ['omega 1', 'omega 2', 'omega 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '405-760', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Kwang Kon Koh', 'investigatorAffiliation': 'Gachon University Gil Medical Center'}}}}