Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 10:47 PM
Study NCT ID:
NCT01301794
Status:
UNKNOWN
Last Update Posted:
2013-02-25
First Post:
2011-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lovaza Mechanisms of Action
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015228', 'term': 'Hypertriglyceridemia'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'C405603', 'term': 'Omacor'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-02-21', 'studyFirstSubmitDate': '2011-02-18', 'studyFirstSubmitQcDate': '2011-02-22', 'lastUpdatePostDateStruct': {'date': '2013-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in lipoprotein metabolite content and their ability to activate PPAR-alpha in an established cell culture system.', 'timeFrame': '3 months', 'description': 'Enrolled subjects will serve as their own controls and will be studied at baseline and after 3 months of Lovaza. The primary endpoint will test changes in lipoproteins as a function of their content and ability to activate PPAR-alpha in standard transfected cell culture systems.'}], 'secondaryOutcomes': [{'measure': 'Changes in plasma markers for atherosclerosis', 'timeFrame': '3 months', 'description': 'Subjects will also be studied before and after Lovaza for changes in lipid profile and c- reactive protein'}, {'measure': 'Change in plasma markers of diabetes', 'timeFrame': '3 months', 'description': 'Plasma markers of diabetes will be measure before and after Lovaza treatment for 3 months, specifically glucose and A1C levels'}, {'measure': 'Changes in plasma markers of liver function', 'timeFrame': '3 months', 'description': 'Plasma levels of liver function tests, specifically ALT and AST before and after 3 months of Lovaza.\n\nThis is not a safety issue since elevated triglycerides can cause increased liver function tests and fish oil (like Lovaza) can lower triglyceride levels and hence ALT and AST levels.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertriglyceridemia', 'Fish oil', 'Omega 3 fatty acids'], 'conditions': ['Moderate Hypertriglyceridemia.']}, 'descriptionModule': {'briefSummary': 'High levels of triglycerides is a common abnormality found in patients with diabetes and also cardiovascular disease, and may contribute to the risk for both. Omega 3 fatty acids, as found enriched in fish and also in the commercial agent called Lovaza lower triglyceride levels. Prior work from the investigators group demonstrated that an enzyme responsible for the break down of triglycerides - lipoprotein lipase - generates molecules that can activate a specific nuclear receptor known as PPAR-alpha. This study investigates the hypothesis that taking Lovaza shifts the specific fatty acid content of triglyceride containing lipoproteins and increases the ability of those lipoproteins to activate PPAR-alpha.', 'detailedDescription': 'This study will investigate changes in lipid and other metabolic parameters as well as the ability of isolated lipoproteins to activate PPARs in the presence or absence of lipoprotein lipase in a cohort of normal healthy individuals with modest hypertriglyceridemia before and after a course of Lovaza.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Otherwise healthy 21 to 65 year old men and women\n* Triglycerides \\>150 \\< 500 mg/dL\n\nExclusion Criteria:\n\n* Other lipid lowering medication including fish oil\n* Major illnesses\n* Diabetes\n* Cardiovascular disease\n* Abnormalities uncovered on screening blood work including undiagnosed diabetes, abnormal liver function tests, triglycerides \\> 500 mg/dL\n* Indication for immediate statin therapy\n* Pregnancy\n* Contraindication for fish oil use or muscle biopsy'}, 'identificationModule': {'nctId': 'NCT01301794', 'briefTitle': 'Lovaza Mechanisms of Action', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Study of the Effects of Lovaza (Omega 3 Fatty Acids) On Lipoprotein Particles and Their Transcriptional Effects', 'orgStudyIdInfo': {'id': 'BWHp001640'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Omega 3 fatty acid (Lovaza)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Lovaza LVZ112737, formerly known as Omacor.', 'Omega 3 fatty acids are also available over the counter but Lovaza is a proprietary form.'], 'description': 'Lovaza is an FDA approved omega 3 fatty acid taken as 4 grams a day (two one gram formulations twice a day).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sutanuka Lahiri', 'role': 'CONTACT', 'email': 'Sutanuka Lahiri <SLAHIRI@PARTNERS.ORG>', 'phone': '617-525-6823'}, {'name': 'Jorge Plutzky', 'role': 'CONTACT', 'email': 'jplutzky@rics.bwh.harvard.edu', 'phone': '326-055-200'}], 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Jorge Plutzky, MD', 'role': 'CONTACT', 'email': 'jplutzky@rics.bwh.harvard.edu', 'phone': '617-525-4360'}, {'name': 'Jon Brown, MD', 'role': 'CONTACT', 'email': 'jbrown0@partners.org', 'phone': '617-525-4360'}], 'overallOfficials': [{'name': 'Jorge Plutzky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}, {'name': 'Jonathan Brown, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Vascular Disease Prevention Program', 'investigatorFullName': 'Jorge Plutzky', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}