Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-04-10 @ 8:17 PM
Study NCT ID:
NCT01577056
Status:
UNKNOWN
Last Update Posted:
2012-04-13
First Post:
2012-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postprandial Lipid Metabolism in Familial Hypercholesterolaemia:Effects of Fish Oils
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015228', 'term': 'Hypertriglyceridemia'}, {'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], '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': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'C405603', 'term': 'Omacor'}, {'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-04-11', 'studyFirstSubmitDate': '2012-04-10', 'studyFirstSubmitQcDate': '2012-04-11', 'lastUpdatePostDateStruct': {'date': '2012-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postprandial changes in triglyceride-rich lipoprotein concentrations', 'timeFrame': '12 weeks', 'description': 'Incremental area-under-the-curve (AUC) for triglycerides, apoB-48 and retinyl palmitate'}], 'secondaryOutcomes': [{'measure': 'Triglyceride-rich lipoprotein kinetics', 'timeFrame': '12 weeks', 'description': 'Kinetic studies of apoB48 and apoB-100 kinetics'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Familial hypercholesterolaemia', 'Postprandial dyslipidaemia', 'Fish oil treatment', 'Cardiovascular disease'], 'conditions': ['Hypertriglyceridaemia', 'Familial Hypercholesterolaemia']}, 'referencesModule': {'references': [{'pmid': '37202042', 'type': 'DERIVED', 'citation': 'Ying Q, Chan DC, Pang J, Croyal M, Blanchard V, Krempf M, Watts GF. Effect of omega-3 fatty acid ethyl esters on postprandial arterial elasticity in patients with familial hypercholesterolemia. Clin Nutr ESPEN. 2023 Jun;55:174-177. doi: 10.1016/j.clnesp.2023.03.012. Epub 2023 Mar 21.'}, {'pmid': '27614801', 'type': 'DERIVED', 'citation': 'Chan DC, Pang J, Barrett PH, Sullivan DR, Mori TA, Burnett JR, van Bockxmeer FM, Watts GF. Effect of omega-3 fatty acid supplementation on arterial elasticity in patients with familial hypercholesterolaemia on statin therapy. Nutr Metab Cardiovasc Dis. 2016 Dec;26(12):1140-1145. doi: 10.1016/j.numecd.2016.07.012. Epub 2016 Aug 3.'}, {'pmid': '27490922', 'type': 'DERIVED', 'citation': 'Chan DC, Pang J, Barrett PH, Sullivan DR, Burnett JR, van Bockxmeer FM, Watts GF. omega-3 Fatty Acid Ethyl Esters Diminish Postprandial Lipemia in Familial Hypercholesterolemia. J Clin Endocrinol Metab. 2016 Oct;101(10):3732-3739. doi: 10.1210/jc.2016-2217. Epub 2016 Aug 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether fish oil supplementation is effective in the treatment of abnormal fat metabolism in subjects with elevated cholesterolaemia.', 'detailedDescription': 'The use of statin therapy in familial hypercholesterolaemia (FH) is known to reduce cardiovascular risk and is a first line recommendation, however, there is considerable residual risk predicted by the presence of fasting and post-prandial hypertriglyceridaemia.\n\nThis study will examine the effect of oral n-3 fatty acid ethyl esters supplementation (4g/day, Omacor) on postprandial hypertriglyceridaemia and post-prandial arterial function when administrated to FH patients at increased risk of cardiovascular disease due to their residual fasting hypertriglyceridaemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with FH (genetically defined LDL-receptor mutation or Dutch score \\>8) on statin treatment only\n* Hypertriglyceridaemia on a random blood sample (triglycerides \\>1.5mml/L)\n\nExclusion Criteria:\n\n* Subjects with diabetes mellitus\n* major systemic illness or use of steroids or other lipid-regulating drugs (such as niacin, fibrate and colesevelam)\n* patients on hypocaloric diets or LDL apheresis; anaemia, haemorrhage and pregnancy.'}, 'identificationModule': {'nctId': 'NCT01577056', 'acronym': 'FIFH', 'briefTitle': 'Postprandial Lipid Metabolism in Familial Hypercholesterolaemia:Effects of Fish Oils', 'organization': {'class': 'OTHER', 'fullName': 'The University of Western Australia'}, 'officialTitle': 'Effect of Fish Oil Supplementation on Postprandial Lipid Metabolism in Familial Hypercholesterolaemia', 'orgStudyIdInfo': {'id': '1028883'}, 'secondaryIdInfos': [{'id': 'NHMRC1028883', 'type': 'OTHER_GRANT', 'domain': 'NHMRC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fish oil', 'interventionNames': ['Dietary Supplement: Fish oil capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'FH subjects with standard treatment (statin treatment)', 'interventionNames': ['Drug: HMG Coenzyme reductase']}], 'interventions': [{'name': 'Fish oil capsule', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Omacor'], 'description': '4g Omega capsule for 12 weeks', 'armGroupLabels': ['Fish oil']}, {'name': 'HMG Coenzyme reductase', 'type': 'DRUG', 'otherNames': ['Statin'], 'description': 'All FH subjects are on standard statin treatment during study period', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6000', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'contacts': [{'name': 'Dick Chan, PhD', 'role': 'CONTACT', 'email': 'dick.chan@uwa.edu.au', 'phone': '61-8-92240268'}], 'facility': 'School of Medicine & Pharmacology,University of Western Australia', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'centralContacts': [{'name': 'Dick Chan, PhD', 'role': 'CONTACT', 'email': 'dick.chan@uwa.edu.au', 'phone': '61-8-92240268'}], 'overallOfficials': [{'name': 'Dick Chan, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Western Australia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Western Australia', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Health and Medical Research Council, Australia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dick C Chan', 'investigatorAffiliation': 'The University of Western Australia'}}}}