Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-06 @ 11:17 PM
Study NCT ID:
NCT06424860
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2024-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fish Oil, Metformin and Heart Health in PCOS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D058226', 'term': 'Plaque, Atherosclerotic'}, {'id': 'D006332', 'term': 'Cardiomegaly'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006984', 'term': 'Hypertrophy'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 146}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2024-04-29', 'studyFirstSubmitQcDate': '2024-05-16', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Carotid intimal medial thickness', 'timeFrame': '12 months', 'description': 'mm'}, {'measure': 'carotid plaque height', 'timeFrame': '12 months', 'description': 'mm'}, {'measure': 'Left ventricular global longitudinal strain (LVGLS)', 'timeFrame': '12 months', 'description': 'percent change in LVGLS'}], 'secondaryOutcomes': [{'measure': 'Blood lipids', 'timeFrame': '12 months', 'description': 'TG, LDL-C, HDL-C, non-HDL-C mmol/l'}, {'measure': 'ApoB-lipoproteins', 'timeFrame': '12 months', 'description': 'apob48 and apoB100 mg/l'}, {'measure': 'remnant-cholesterol', 'timeFrame': '12 months', 'description': 'mmol/l'}, {'measure': 'Testosterone', 'timeFrame': '12 months', 'description': 'nmol/l'}, {'measure': 'insulin', 'timeFrame': '12 months', 'description': 'pmol/l'}, {'measure': 'glucose', 'timeFrame': '12 months', 'description': 'mmol/l'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PCOS', 'Cardiovascular Disease', 'Atherosclerotic Cardiovascular Disease', 'Atherosclerotic Plaque', 'Cardiac Hypertrophy']}, 'descriptionModule': {'briefSummary': 'Women with Polycystic Ovary Syndrome (PCOS) have high testosterone levels which is associated with altered insulin-glucose metabolism and an adverse blood lipid profile, predisposing them to the development of Type II Diabetes and Cardiovascular Disease (CVD). This study will investigate the use of dietary fish oil supplementation as a safe and effective intervention, and as an adjunct therapy to standard of care treatment with metformin to improve heart health, blood lipids and insulin-glucose metabolism in women with PCOS, and those with PCOS and Type 2 Diabetes.', 'detailedDescription': 'OBJECTIVES The objective in this proposed study is to determine the effect of dietary fish oil supplementation with metformin compared to standard of care metformin-alone treatment for 12 months on plasma lipids and apoB- remnant lipoprotein metabolism, and atherosclerotic cardiovascular disease and cardiac function in high-risk overweight-obese young individuals with PCOS.\n\nThis study will provide evidence-based research on the efficacy of fish oil, in the form as an adjunct therapy to standard treatment with metformin, as a safe nutritional treatment to add to therapeutic guidelines to reduce early CVD risk in young women with PCOS.\n\nSpecific Objectives;\n\n1. To quantify carotid intimal medical thickness (cIMT) and plaque height before and after the intervention to assess the effect of fish oil supplementation combined with metformin standard of care on atherosclerotic cardiovascular disease and cardiac function.\n2. To determine the effects of dietary fish oil supplementation combined with metformin and metformin standard of care on fasting and non-fasting plasma TG, apoB48 and apoB100-lipoprotein concentrations, and cardiac function variables including left ventricular (LV) posterior wall thickness, LV ejection fraction.\n3. To assess the effect of dietary fish oil supplementation on insulin, glucose, and endocrine parameters.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of PCOS\n* overweight-obese (BMI \\>25 kg/m2)\n* elevated fasting plasma TG (\\>150 mg/dL)\n* and/or apoB48-remnant cholesterol lipoproteins (\\>20 ug/ml)\n* impaired insulin sensitivity (glucose 100-125 mg/dL and/or insulin \\>15 (uM/ml), and may be diagnosed with T2D (blood glucose \\>126 mg/dL).\n\nExclusion Criteria:\n\n-pregnancy, lactation'}, 'identificationModule': {'nctId': 'NCT06424860', 'briefTitle': 'Fish Oil, Metformin and Heart Health in PCOS', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Dietary Fish Oil and Metformin Intervention for Heart Health in PCOS', 'orgStudyIdInfo': {'id': '00141704'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin', 'description': 'metformin (1500mg/d) and placebo (olive oil capsule)', 'interventionNames': ['Drug: Metformin']}, {'type': 'EXPERIMENTAL', 'label': 'Fishoil and metformin', 'description': 'metformin (1500mg/d) and fish oil (4000mg/d)', 'interventionNames': ['Dietary Supplement: Fish oil', 'Combination Product: Fish Oil and Metformin']}], 'interventions': [{'name': 'Fish oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'For 12 months', 'armGroupLabels': ['Fishoil and metformin']}, {'name': 'Metformin', 'type': 'DRUG', 'description': '12 months', 'armGroupLabels': ['Metformin']}, {'name': 'Fish Oil and Metformin', 'type': 'COMBINATION_PRODUCT', 'description': '12 months', 'armGroupLabels': ['Fishoil and metformin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2E1', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Donna Vine, PhD', 'role': 'CONTACT', 'email': 'dvine@ualberta.ca', 'phone': '780-492-4393'}, {'name': 'Beate Sydora, PhD', 'role': 'CONTACT', 'email': 'bsydora@ualberta.ca', 'phone': '780-940-1476'}], 'facility': 'Human Nutrition Research Unit - Li Ka Shing Health Research Center', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T6G-2B7', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Donna Vine, PhD', 'role': 'CONTACT', 'email': 'dvine@ualberta.ca', 'phone': '780-492-4393'}, {'name': 'Beate Sydora, PhD', 'role': 'CONTACT', 'email': 'bsydora@ualberta.ca', 'phone': '780-940-1476'}], 'facility': 'Mazankowski Alberta Heart Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T6G-2B7', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Beate Sydora, PhD', 'role': 'CONTACT', 'email': 'reoffice@ualberta.ca', 'phone': '7804920302'}, {'name': 'Beate Sydora', 'role': 'CONTACT'}], 'facility': 'University of Alberta Hospital - Division of Endocrinology', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'centralContacts': [{'name': 'Donna Vine, PhD', 'role': 'CONTACT', 'email': 'dvine@ualberta.ca', 'phone': '780-492-4393'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heart and Stroke Foundation of Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}