[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548735":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":42,"responsibleParty":83,"collaborators":85,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":27,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":27,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":27,"overallStatus":45,"whyStopped":27,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"University of Alberta","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Metformin","ACTIVE_COMPARATOR","metformin (1500mg\u002Fd) and placebo (olive oil capsule)",[13],"Drug: Metformin",{"label":15,"type":16,"description":17,"interventionNames":18},"Fishoil and metformin","EXPERIMENTAL","metformin (1500mg\u002Fd) and fish oil (4000mg\u002Fd)",[19,20],"Dietary Supplement: Fish oil","Combination Product: Fish Oil and Metformin",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DIETARY_SUPPLEMENT","Fish oil","For 12 months",[15],null,{"type":29,"name":9,"description":30,"armGroupLabels":31,"otherNames":27},"DRUG","12 months",[9],{"type":33,"name":34,"description":30,"armGroupLabels":35,"otherNames":27},"COMBINATION_PRODUCT","Fish Oil and Metformin",[15],[37],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},"Donna Vine, PhD","CONTACT","780-492-4393","dvine@ualberta.ca",[43,63,72],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Human Nutrition Research Unit - Li Ka Shing Health Research Center","RECRUITING","Edmonton","Alberta","T6G 2E1","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-113.46871,53.55014,{"lat":55,"lon":54},[58,59],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},{"name":60,"role":39,"phone":61,"phoneExt":27,"email":62},"Beate Sydora, PhD","780-940-1476","bsydora@ualberta.ca",{"facility":64,"status":45,"city":46,"state":47,"zip":65,"country":49,"countryCode":50,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},"Mazankowski Alberta Heart Institute","T6G-2B7",{"type":52,"coordinates":67},[54,55],{"lat":55,"lon":54},[70,71],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},{"name":60,"role":39,"phone":61,"phoneExt":27,"email":62},{"facility":73,"status":45,"city":46,"state":47,"zip":65,"country":49,"countryCode":50,"cosmosGeoPoint":74,"geoPoint":76,"contacts":77},"University of Alberta Hospital - Division of Endocrinology",{"type":52,"coordinates":75},[54,55],{"lat":55,"lon":54},[78,81],{"name":60,"role":39,"phone":79,"phoneExt":27,"email":80},"7804920302","reoffice@ualberta.ca",{"name":82,"role":39,"phone":27,"phoneExt":27,"email":27},"Beate Sydora",{"type":84,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[86],{"name":87,"class":6},"Heart and Stroke Foundation of Canada","100548735","phase-1-fish-oil-metformin-and-heart-health-in-pcos-100548735",false,"NCT06424860","Fish Oil, Metformin and Heart Health in PCOS","Dietary Fish Oil and Metformin Intervention for Heart Health in PCOS","Inclusion Criteria:\n\n* diagnosis of PCOS\n* overweight-obese (BMI \\>25 kg\u002Fm2)\n* elevated fasting plasma TG (\\>150 mg\u002FdL)\n* and\u002For apoB48-remnant cholesterol lipoproteins (\\>20 ug\u002Fml)\n* impaired insulin sensitivity (glucose 100-125 mg\u002FdL and\u002For insulin \\>15 (uM\u002Fml), and may be diagnosed with T2D (blood glucose \\>126 mg\u002FdL).\n\nExclusion Criteria:\n\n-pregnancy, lactation","FEMALE","25 Years","45 Years",{"count":99,"type":100},146,"ESTIMATED","INTERVENTIONAL",[103],"PHASE1","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.",[106,107,108,109,110],"PCOS","Cardiovascular Disease","Atherosclerotic Cardiovascular Disease","Atherosclerotic Plaque","Cardiac Hypertrophy","2025-12-04",{"date":113,"type":114},"2025-12-12","ACTUAL",{"date":116,"type":114},"2025-11-01",{"date":118,"type":100},"2027-12-30",{"name":5,"class":6},3]