[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511051":3},{"organization":4,"outcomesModule":7,"designInfo":62,"detailedDescription":69,"studyPopulation":61,"armGroups":70,"interventions":83,"overallOfficials":96,"centralContacts":100,"locations":107,"responsibleParty":126,"collaborators":129,"id":134,"slug":61,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":141,"sex":142,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":61,"studyType":148,"phases":149,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":110,"whyStopped":61,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},{"fullName":5,"class":6},"Université de Sherbrooke","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":26,"otherOutcomes":61},[9,13,15,19,23],{"measure":10,"description":11,"timeFrame":12},"Change in white adipose tissue dietary fatty acid (DFA) trapping and partitioning","\\[18F\\]-FTHA PET","measured after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)",{"measure":14,"description":11,"timeFrame":12},"Change in lean organ (liver, heart and muscle) DFA uptake and partitioning",{"measure":16,"description":17,"timeFrame":18},"Change in liver non-esterified fatty acid (NEFA) uptake, oxidation, esterification and secretion into very low-density lipoprotein (VLDL).","calculated from the same multicompartmental equation using liver \\[11C\\]-palmitate kinetics","measured before and after liquid meal at Baseline (A0), at Day 12 (B0) and at Week 52 (C0)",{"measure":20,"description":21,"timeFrame":22},"Change in Endogenous Glucose production and meal glucose systemic flux","i.v. and oral stable isotope tracer","measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)",{"measure":24,"description":25,"timeFrame":18},"Change in cardiac non-esterified fatty acid (NEFA) uptake, oxidation and esterification","calculated from the same multicompartmental equation using cardiac \\[11C\\]-palmitate kinetics",[27,30,34,37,40,43,46,49,51,55,58],{"measure":28,"description":29,"timeFrame":22},"Change in plasma NEFA flux","calculated from i.v. stable isotope tracer (mass spectrometry).",{"measure":31,"description":32,"timeFrame":33},"Change in hepatic Triglyceride (TG) content","magnetic resonance imaging (MRI)","measured at Baseline (A0), at Day 12 (B0) and at Week 52 (C0)",{"measure":35,"description":36,"timeFrame":22},"Change in insulin secretion","Determined by measuring C-peptide kinetics following the liquid meal",{"measure":38,"description":39,"timeFrame":22},"Change in total substrate utilisation","measured by using indirect calorimetry",{"measure":41,"description":42,"timeFrame":33},"Change in gene and protein expression of white adipose tissue (WAT)","WAT biopsy",{"measure":44,"description":45,"timeFrame":22},"Change in hormonal response","Multiplex assay",{"measure":47,"description":48,"timeFrame":22},"Change in insulin resistance \u002Fsensitivity","Determined by measuring circulating glucose, NEFA and insulin following the liquid meal",{"measure":50,"description":42,"timeFrame":33},"Change in histology of white adipose tissue (WAT)",{"measure":52,"description":53,"timeFrame":54},"Change in metabolite response","Colorimetric assay","measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0",{"measure":56,"description":57,"timeFrame":22},"Change in plasma distribution of DFA metabolites (WAT DFA spillover)","calculated from i.v. and oral stable isotope tracers (mass spectrometry) incorporated into triglyceride-rich lipoproteins and NEFA.",{"measure":59,"description":60,"timeFrame":22},"Change in glycerol turnover","calculated from \\[1,1,2,3,3-2H\\]-glycerol i.v.",null,{"allocation":63,"interventionModel":64,"interventionModelDescription":65,"primaryPurpose":66,"observationalModel":61,"timePerspective":61,"maskingInfo":67},"NON_RANDOMIZED","PARALLEL","It will be a randomized crossover study prior to bariatric surgery (visits A0 and A1) followed by a longitudinal follow-up study after surgery (visits B0 and C0) in two groups (type 2 diabetes vs. controls). Inside each group, the protocol will be carried out as a within-subject, in which each subject will serve as his\u002Fher own control.","BASIC_SCIENCE",{"masking":68,"maskingDescription":61,"whoMasked":61},"NONE","This clinical assay will include 5 visits: the screening visit and four 9-hour postprandial metabolic sessions (A0, A1, B0 and C0) before and after surgery:\n\n* initial visit: screening\n* before surgery: 2 metabolic sessions A0 and A1 (without\u002Fwith niacin) will be performed, in random order, at least one week interval.\n* 12 days post surgery: 1 metabolic session B0 (without niacin)\n* 1 year post surgery: 1 metabolic session C0 (without niacin)\n\nEach metabolic visit will last 9 hours with:\n\n* perfusion of stable tracers,\n* ingestion of a liquid meal\n* Positron-Emitting-Tomography (PET) acquisitions using radiopharmaceuticals such as \\[18F\\]-fluoro-6-thia-heptadecanoic acid (\\[18F\\]-FTHA) and \\[11C\\]-palmitate,\n* MRI acquisitions.\\[18F\\]fluoro-6-thia-heptadecanoic acid (FTHA).\n\nThe niacin will be given during metabolic visits A1 as a regulator of lipids metabolism. During these visits, the subjects will ingest 150mg every half hour for 6 hours. Niacin will be used as a pharmacological suppressor of dietary fatty acid (DFA) spillover in order to determine the role played by this mechanism in the reduction of postprandial endogen glucose production (EGP) in T2D after bariatric surgery.",[71,78],{"label":72,"type":73,"description":74,"interventionNames":75},"Control group","ACTIVE_COMPARATOR","without T2D according to Diabetes Canada diagnostics criteria:",[76,77],"Procedure: Bariatric surgery","Drug: Nicotinic Acid",{"label":79,"type":80,"description":81,"interventionNames":82},"group with Type 2 diabetes","EXPERIMENTAL","with T2D according to Diabetes Canada diagnostics criteria:",[76,77],[84,89],{"type":85,"name":86,"description":87,"armGroupLabels":88,"otherNames":61},"PROCEDURE","Bariatric surgery","Laparoscopic Sleeve Gastrectomy",[72,79],{"type":90,"name":91,"description":92,"armGroupLabels":93,"otherNames":94},"DRUG","Nicotinic Acid","Only during A1. 150mg every half hour for 6 hours. A total dose of 1800mg will be ingested.",[72,79],[95],"Niacin",[97],{"name":98,"affiliation":5,"role":99},"André Carpentier, MD","PRINCIPAL_INVESTIGATOR",[101],{"name":102,"role":103,"phone":104,"phoneExt":105,"email":106},"Frédérique Frisch","CONTACT","1-819-346-1110","12394","frederique.frisch@usherbrooke.ca",[108],{"facility":109,"status":110,"city":111,"state":112,"zip":113,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":121,"contacts":122},"centre de recherche du CHUS","RECRUITING","Sherbrooke","Quebec","J1H 5N4","Canada","CA",{"type":117,"coordinates":118},"Point",[119,120],-71.89908,45.40008,{"lat":120,"lon":119},[123],{"name":124,"role":103,"phone":125,"phoneExt":61,"email":106},"Frederique Frisch","8193461110",{"type":99,"investigatorFullName":127,"investigatorTitle":128,"investigatorAffiliation":5,"oldNameTitle":61,"oldOrganization":61},"André Carpentier","Tenure professor",[130,132],{"name":131,"class":6},"Institut universitaire de cardiologie et de pneumologie de Québec, University Laval",{"name":133,"class":6},"Centre de recherche du Centre hospitalier universitaire de Sherbrooke","100511051",false,"NCT05934409","Adipose Tissue Storage in the Rapid Remission of Hepatic and Cardiac Metabolic Dysfunction After Bariatric Surgery","Improved Adipose Tissue Storage of Dietary Fatty Acids as a New Mechanism for the Rapid Remission of Hepatic and Cardiac Metabolic Dysfunction After Bariatric Surgery","CB5","Inclusion Criteria:\n\n* Aged 18 to 65\n* BMI 35 kg\u002Fm2\n* Diagnosed T2D - according to Diabetes Canada diagnostics criteria.\n* Diagnosed non-T2D - according to Diabetes Canada diagnostics criteria.\n* Women with a negative serum pregnancy test.\n\nExclusion Criteria:\n\n* Treatment with an oral contraceptive;\n* Treatment with fibrate, thiazolidinedione, insulin, or beta-blocker, drugs that affect metabolism and cannot be stopped temporarily or which have long-lasting effects;\n* Presence of overt cardiovascular disease, liver or renal failure or other uncontrolled medical conditions;\n* Any other contraindication to surgery or to temporarily suspending current medications for diabetes, lipids or hypertension;\n* Smoking or consumption of more than 2 alcoholic beverages per day;\n* Any contraindication to MRI;\n* A Diabetes Remission (DiaRem) score \\>8 (low probability of T2D remission);\n* Having participated to a research study with exposure to radiation in the last two years before the start of the study;\n* Pregnant or breastfeeding women;\n* Patients weighing more than 200 kg to respect the weight and gantry limit of our MRI and PET\u002FCT scanners.\n* Being allergic to eggs",true,"ALL","18 Years","65 Years",{"count":146,"type":147},40,"ESTIMATED","INTERVENTIONAL",[150],"NA","The present protocol aims to understand and establish whether there is a causal link between adipose tissue metabolic remodeling and Type 2 Diabetes (T2D) remission after bariatric surgery.\n\nAll participants will have a bariatric surgery, divided in 2 groups: with or without T2D.",[153],"Diabetes Mellitus Type 2",[86,155,156,157],"remission from Type 2 diabetes","PET imaging","adipose tissue","2026-02-09",{"date":160,"type":161},"2026-02-10","ACTUAL",{"date":163,"type":161},"2023-11-01",{"date":165,"type":147},"2028-05-01",{"name":5,"class":6},1]