[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574805":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":37,"centralContacts":42,"locations":51,"responsibleParty":73,"collaborators":29,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":29,"enrollmentInfo":86,"targetDuration":29,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":104,"whyStopped":29,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Institut universitaire de cardiologie et de pneumologie de Québec, University Laval","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Nutrition","ACTIVE_COMPARATOR","This arm will only participate in an individualized nutritionnal approach.",[13],"Other: Diet",{"label":15,"type":10,"description":16,"interventionNames":17},"Nutrition + Semaglutide","This arm will initiate a pharmacological intervention to treat obesity (Semaglutide) and will participate in an individualized nutritionnal approach.",[18,13],"Drug: semaglutide",{"label":20,"type":10,"description":21,"interventionNames":22},"Semaglutide","This arm will only initiate a pharmacological intervention to treat obesity (Semaglutide)",[18],[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","semaglutide","Participants receiving this intervention will be starting with a dose of semaglutide 0.25 mg. Physicians will follow Wegovy® Dosing Schedule guidelines, ending with a final dose of 2.4 mg at the fifth month. Type 2 diabetes participants wishing to stop at 1.0 mg will be allowed.",[15,20],null,{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Diet","Participants receiving this intervention will be seeing a registered dietician at each visit. The individualized approach will be based on recent literature (mostly hypocaloric) by using different methods.",[9,15],[35,36],"Individualized nutritionnal intervention","Nutritionnal counselling",[38],{"name":39,"affiliation":40,"role":41},"Fannie Lajeunesse-Trempe, MD., Ph.D.","Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval","PRINCIPAL_INVESTIGATOR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":29,"email":47},"Tristan Rocheleau, RD., M.Sc.","CONTACT","418-656-8711, #2681","tristan.rocheleau.2@ulaval.ca",{"name":39,"role":45,"phone":49,"phoneExt":29,"email":50},"418-656-8711, #8052","fanny.lajeunesse-trempe.1@ulaval.ca",[52],{"facility":40,"status":29,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Québec","Quebec","G1V 4G5","Canada","CA",{"type":59,"coordinates":60},"Point",[61,62],-71.21454,46.81228,{"lat":62,"lon":61},[65,68,69,71],{"name":66,"role":45,"phone":67,"phoneExt":29,"email":47},"Tristan Rocheleau, RD., Ph.D.(c)","5819969946",{"name":39,"role":45,"phone":29,"phoneExt":29,"email":29},{"name":70,"role":45,"phone":29,"phoneExt":29,"email":29},"André Tchernof, Ph.D.",{"name":72,"role":45,"phone":29,"phoneExt":29,"email":29},"André Marette, Ph.D.",{"type":41,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Fannie Lajeunesse-Trempe","Principal Investigator","100574805","characterization-and-management-of-metabolic-dysfunction-associated-fatty-liver-disease-mafld-100574805",false,"NCT06764056","Characterization and Management of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)","Characterization and Management of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) Through an Individualized Nutritionnal Approach and Semaglutide Therapy.","METAfoie","Inclusion Criteria:\n\n* Body mass index between 30 and 50 kg\u002Fm2;\n* Stade 2 or 3 (S2 or S3) hepatic steatosis with or without liver fibrosis.\n\nExclusion Criteria:\n\n* Type 1 diabetes diagnosis;\n* Alcohol consumption exceeding recommendations \\[\\>140 g\u002Fweek (women) and \\>210 g\u002Fweek (men)\\];\n* Known chronic hepatic disease non-steatotic at the entry of the study (Wilson's disease, hemochromatosis, alpha-1-antitrypsin deficiency, viral hepatitis, auto-immune hepatitis, etc.);\n* Pharmacological treatment targeting obesity active or ended in the last 3 months;\n* Bariatric surgery;\n* Gastro-intestinal pathologies (GI cancers, IBD, etc.);\n* Capsulated probiotics consumption;\n* Antibiotic treatment in the last 3 months;\n* Pregnancy;\n* Cirrhosis diagnosis (hepatic decompensation).","ALL","18 Years",{"count":87,"type":88},120,"ESTIMATED","INTERVENTIONAL",[91],"NA","The goal of this clinical trial is to improve the treatment of hepatic steatosis associated with obesity with pharmacological and nutritionnal approaches. The main question it aims to answer is:\n\nDoes an individualized nutritionnal approach with a dietician combined with medication targeting obesity is the most efficient way to treat hepatic steatosis associated with obesity?\n\nParticipants will either participate in one of three groups:\n\n* Nutrition: Participant will only have a regular follow-up with a registered dietician;\n* Nutrition + Semaglutide: Participants will start a new medication targeting obesity and will have a regular follow-up with a registered dietician;\n* Semaglutide: Participants will start a new medication targeting obesity.",[94,95,96],"Metabolic Associated Fatty Liver Disease","Metabolic Associated-dysfunction Steatohepatitis (MASH)","Obesity",[96,98,99,100,9,101,20,102,103],"Metabolic associated fatty liver disease","GLP-1 receptor analogs","Pharmacotherapy","Transient elastography","Microbiome","Lipidomics","NOT_YET_RECRUITING","2025-01-07",{"date":107,"type":108},"2025-01-08","ACTUAL",{"date":110,"type":88},"2025-01",{"date":112,"type":88},"2026-05",{"name":5,"class":6},1]