[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638542":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":38,"centralContacts":43,"locations":53,"responsibleParty":74,"collaborators":78,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":30,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":106,"overallStatus":131,"whyStopped":30,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Institut de Recherches Cliniques de Montreal","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Eicosapentaenoic acid (EPA)","ACTIVE_COMPARATOR","4 g EPA per day",[13],"Dietary Supplement: Fish Oil",{"label":15,"type":10,"description":16,"interventionNames":17},"Docosahexaenoic acid (DHA)","4 g DHA per day",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Corn oil","PLACEBO_COMPARATOR","0 g EPA and DHA per day",[23],"Dietary Supplement: Corn oil control",[25,31,34],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DIETARY_SUPPLEMENT","Fish Oil","Four softgels of Carlson Elite EPA Gems taken orally per day (NPN 80079735, 1 g EPA\u002Fsoftgel)",[9],null,{"type":26,"name":27,"description":32,"armGroupLabels":33,"otherNames":30},"Four softgels of Carlson Elite DHA Gems taken orally per day (NPN 80079736, 1 g DHA\u002Fsoftgel)",[15],{"type":26,"name":35,"description":36,"armGroupLabels":37,"otherNames":30},"Corn oil control","Four softgels of Carlson placebo taken orally per day (food-grade corn oil, 0 g EPA and DHA per softgel)",[19],[39],{"name":40,"affiliation":41,"role":42},"May Faraj, P.Dt., Ph.D.","Institut de recherches cliniques de Montréal (IRCM)\u002F Université de Montréal","PRINCIPAL_INVESTIGATOR",[44,50],{"name":45,"role":46,"phone":47,"phoneExt":48,"email":49},"Justine Fricher, M.Sc.","CONTACT","514-987-5500","3260","t2dresearch@ircm.qc.ca",{"name":51,"role":46,"phone":52,"phoneExt":30,"email":49},"Clinical coordinator and nurse","514-987-5655",[54],{"facility":55,"status":30,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Institut de recherches cliniques de Montréal (IRCM)","Montreal","Quebec","H2W 1R7","Canada","CA",{"type":62,"coordinates":63},"Point",[64,65],-73.58781,45.50884,{"lat":65,"lon":64},[68,70,71],{"name":40,"role":46,"phone":30,"phoneExt":30,"email":69},"T2Dresearch@ircm.qc.ca",{"name":40,"role":42,"phone":30,"phoneExt":30,"email":30},{"name":72,"role":73,"phone":30,"phoneExt":30,"email":30},"Study physician: Remi Rabasa-Lhoret, M.D., Ph.D.","SUB_INVESTIGATOR",{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","May Faraj, PDt, PhD","Professor",[79],{"name":80,"class":6},"Diabetes Canada","100638542","phase-2-effects-of-different-fish-oil-types-on-type-2-diabetes-risk-factors-in-high-risk-adults-100638542",false,"NCT07575438","Effects of Different Fish Oil Types on Type 2 Diabetes Risk Factors in High-Risk Adults","Role of EPA and DHA as Tailored Therapy for People Living With Obesity and High-risk for Type 2 Diabetes (END-T2D): a Randomized Controlled Trial","END-T2D","Inclusion Criteria:\n\nMales and post-menopausal females:\n\n* With a body mass index (BMI \\>25-40 kg\u002Fm2)\n* Having confirmed menopausal status (FSH ≥ 30 U\u002Fl)\n* Non-smokers (tobacco) or have quitted for over a year\n* Low-moderate alcohol consumption: \\\u003C7 alcoholic servings\u002F week\n* Plasma apoB ≥1.05 g\u002FL\n\nExclusion Criteria:\n\n* Elevated risk of cardiovascular disease (≥ 20% of calculated Framingham Risk Score)\n* Prior history of cardiovascular events (e.g. stroke, transient ischemic attack, myocardial infarction, angina, heart failure, arrhythmias, flutter, atrial …)\n* Systolic blood pressure \\> 140 mmHg or diastolic blood pressure \\> 90 mmHg\n* Diabetes or HbA1c ≥ 6.5%\n* Reactive hypoglycaemia\n* Prior history of cancer within the last 3 years or if lymph nodes were removed\n* Thyroid disease - untreated or unstable Synthroid dose\n* Severe renal dysfunction - eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²\n* Hepatic dysfunction - AST\u002FALT \\> 3 times normal limit\n* Anemia - Hb \\\u003C 120 g\u002FL in females and \\\u003C 130 in males\n* Bleeding disorders\n* Blood coagulation problems (i.e. bleeding predisposition)\n* Malabsorptive disease or surgeries (e.g. bariatric surgeries)\n* Autoimmune and chronic inflammatory disease (i.e. celiac, inflammatory bowel, Graves, multiple sclerosis, psoriasis, rheumatoid arthritis, and lupus).\n* Chronic diarrhea\n* Cholecystectomy (e.g. removal of gall bladder)\n* Sleep apnea\n* Seizures\n* Known history of difficulties accessing a vein\n* Known history of vagal shock or loss of consciousness during blood withdrawal\n* Concomitant medications (systemic corticosteroids; hypertension medication; anti-psychotic medications - psycho-active medication that promote weight gain; anticoagulant or anti-aggregates treatment (e.g. aspirin, NSAIDs, warfarin, coumadin..); systemic adrenergic agonists; weight-loss medication (e.g. GLP-1 agonists); lipid lowering medication (e.g. statins, anti-PCSK9); )\n* Allergy to seafood\u002Ffish or corn oil\n* Allergy to bovine gelatine or glycerine (softgel components)\n* Allergy to Xylocaine (anesthesia used during fat tissue biopsy)\n* Anticipated surgery or blood transfusion\n* Known substance abuse\n* Very high physical activity (\\> 5 hours of aerobic exercise per week)\n* Already taking more than 1 gm of EPA and\u002For DHA supplementation per day\n* Lack of compliance to the study requirements (i.e. not being fasting)\n* Cancellation of the same scheduled testing visit more than once\n* Lack of time to participate in the full length of the study (18-22 weeks)\n* Other conditions deemed inappropriate by the study physician (e.g. difficulties in understanding\u002Fcommunicating in French or English)",true,"ALL","40 Years","70 Years",{"count":94,"type":95},84,"ESTIMATED","INTERVENTIONAL",[98],"PHASE2","The purpose of this clinical trial is to find out whether one type of fish oil works better than another at improving metabolic health in people who are at high risk of developing type 2 diabetes.\n\nSome metabolic problems-such as difficulty controlling blood sugar, unhealthy particles that transport cholesterol in the blood, and poor fat tissue function-can increase the risk of type 2 diabetes. This study aims to determine whether different types of fish oil can:\n\n1. Improve how well the body produces insulin and responds to it,\n2. Improve the quality of the particles that carry \"bad\" cholesterol in the blood, and 3) Improve the health and function of participants' fat tissue.\n\nTo answer these questions, researchers will compare the effects of two types of fish oil: EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid). These will be compared with corn oil, which is used as a placebo and does not contain EPA or DHA.\n\nWhen included in this study, participants will:\n\nA) Take softgel capsules containing EPA, DHA, or placebo (corn oil) every day for 12 weeks, B) Keep a daily log to record when they take their study softgels, and C) Visit the research unit six times, including one and a half days before and after the intervention, to complete specialized metabolic tests that are mostly only available in research settings.",[101,102,103,104,105],"Type 2 Diabetes","Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)","Prediabetes \u002F Type 2 Diabetes","Obesity & Overweight","Obesity and Diabetes Mellitus, Type 2",[107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130],"Omega-3 fatty acids","EPA","DHA","Low-density lipoproteins","LDL","Overweight","Obesity","Insulin secretion","Insulin sensitivity","LDL size","LDL diameter","Inflammation","White adipose tissue","HyperapoB","Prediabetes","Botnia clamp","Intravenous glucose tolerance test","Hyperinsulinemic euglycemic clamp","Adipose tissue needle biopsy","Oral glucose tolerance test","Eicosapentaenoic acid","Docosahexaenoic acid","High plasma apoB","Disposition index","NOT_YET_RECRUITING","2026-05-08",{"date":134,"type":135},"2026-05-12","ACTUAL",{"date":137,"type":95},"2026-07",{"date":139,"type":95},"2029-12",{"name":76,"class":6},1]