[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100407132":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":47,"responsibleParty":226,"collaborators":228,"id":232,"slug":233,"hasResults":234,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":234,"sex":240,"minAge":241,"maxAge":242,"enrollmentInfo":243,"targetDuration":26,"studyType":246,"phases":247,"briefSummary":249,"conditions":250,"keywords":253,"overallStatus":50,"whyStopped":26,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":265},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Metformin + Standard care","EXPERIMENTAL","The pharmacological treatment (Metformin) will start at dose of 850 mg once daily and, at one month, increased to 850 mg twice daily. The dosage will be adjusted if necessary because of gastrointestinal symptoms and information on dose change during follow-up will be collected Adherence to study medications will be assessed by pills count and plasmatic dosage (Metformin group).\n\nAll participants will receive standardized lifestyle recommendations regularly during all the time of the study Lifestyle recommendations will be provided by a nutritionist\u002Fdiabetologist every 6 months at each study visit and reinforced by dedicated consultations with a dietician and a physical activity coach as usually performed in each center. This follow-up will be standardized for each center and applied equally to patients of both groups.\n\nAncillary study measuring metformin-induced enterohormones secretion will be performed on a subgroup of 30 patients randomized in this arm.",[13,14,15],"Drug: Metformin","Other: Standard Care","Dietary Supplement: Standardized meal",{"label":17,"type":6,"description":18,"interventionNames":19},"Standard Care","All participants will receive standardized lifestyle recommendations regularly during all the time of the study Lifestyle recommendations will be provided by a nutritionist\u002Fdiabetologist every 6 months at each study visit and reinforced by dedicated consultations with a dietician and a physical activity coach as usually performed in each center. This follow-up will be standardized for each center and applied equally to patients of both groups.\n\nAncillary study measuring metformin-induced enterohormones secretion will be performed on a subgroup of 30 patients randomized in this arm.",[14,15],[21,27,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Metformin","Metformin will start at dose of 850 mg once daily and, at one month increased to 850 mg twice daily",[9],null,{"type":6,"name":17,"description":17,"armGroupLabels":28,"otherNames":26},[9,17],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":26},"DIETARY_SUPPLEMENT","Standardized meal","Measurements of metformin-induced enterohormones secretion will be done after standardized meal test in a subgroup of patients (ancillary study)",[9,17],[35],{"name":36,"affiliation":37,"role":38},"Claire CARETTE, MD","claire.carette@aphp.fr","PRINCIPAL_INVESTIGATOR",[40,44],{"name":41,"role":42,"phone":26,"phoneExt":26,"email":43},"Aurélie GUIMFACK","CONTACT","aurelie.guimfack@aphp.fr",{"name":45,"role":42,"phone":26,"phoneExt":26,"email":46},"Yvann FRIGOUT","yvann.frigout@aphp.fr",[48,64,73,85,97,109,121,133,145,150,162,171,180,189,201,214],{"facility":49,"status":50,"city":51,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"CHU Amiens-Picardie - hôpital Nord","RECRUITING","Amiens","France","FR",{"type":55,"coordinates":56},"Point",[57,58],2.3,49.9,{"lat":58,"lon":57},[61],{"name":62,"role":42,"phone":26,"phoneExt":26,"email":63},"Jean-Daniel Lalau, MD","lalau.jean-daniel@chu-amiens.fr",{"facility":65,"status":66,"city":67,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":68,"geoPoint":72,"contacts":26},"AP-HP - hôpital Avicenne","WITHDRAWN","Bobigny",{"type":55,"coordinates":69},[70,71],2.45012,48.90982,{"lat":71,"lon":70},{"facility":74,"status":50,"city":75,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"CHU de Bordeaux - hôpital Haut-Lévêque","Bordeaux",{"type":55,"coordinates":77},[78,79],-0.58046,44.84124,{"lat":79,"lon":78},[82],{"name":83,"role":42,"phone":26,"phoneExt":26,"email":84},"Maud Monsaingeon-Henry, MD","maud.monsaingeon-henry@chu-bordeaux.fr",{"facility":86,"status":50,"city":87,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"AP-HP - hôpital Ambroise-Paré","Boulogne-Billancourt",{"type":55,"coordinates":89},[90,91],2.24128,48.83545,{"lat":91,"lon":90},[94],{"name":95,"role":42,"phone":26,"phoneExt":26,"email":96},"Marion Bretault, MD","marion.bretault@aphp.fr",{"facility":98,"status":50,"city":99,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"AP-HP - hôpital Louis-Mourier","Colombes",{"type":55,"coordinates":101},[102,103],2.25404,48.91882,{"lat":103,"lon":102},[106],{"name":107,"role":42,"phone":26,"phoneExt":26,"email":108},"Séverine Ledoux, MD","severine.ledoux@aphp.fr",{"facility":110,"status":50,"city":111,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Centre hospitalier intercommunal de Créteil","Créteil",{"type":55,"coordinates":113},[114,115],2.46569,48.79266,{"lat":115,"lon":114},[118],{"name":119,"role":42,"phone":26,"phoneExt":26,"email":120},"Perle Sayedoff, MD","perle.sayedoff@chicreteil.fr",{"facility":122,"status":50,"city":123,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"CHU de Lille - hôpital Claude Huriez","Lille",{"type":55,"coordinates":125},[126,127],3.05512,50.63391,{"lat":127,"lon":126},[130],{"name":131,"role":42,"phone":26,"phoneExt":26,"email":132},"Hélène Verkindt, MD","helene.verkindt@chu-lille.fr",{"facility":134,"status":50,"city":135,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"AP-HM - hôpital de la Conception","Marseille",{"type":55,"coordinates":137},[138,139],5.38107,43.29695,{"lat":139,"lon":138},[142],{"name":143,"role":42,"phone":26,"phoneExt":26,"email":144},"Bénédicte Gaborit, MD","benedicte.gaborit@ap-hm.fr",{"facility":146,"status":66,"city":135,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":147,"geoPoint":149,"contacts":26},"AP-HM - hôpital Nord",{"type":55,"coordinates":148},[138,139],{"lat":139,"lon":138},{"facility":151,"status":50,"city":152,"state":26,"zip":153,"country":52,"countryCode":53,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"AP-HP - hôpital européen Georges-Pompidou","Paris","75015",{"type":55,"coordinates":155},[156,157],2.3488,48.85341,{"lat":157,"lon":156},[160],{"name":161,"role":42,"phone":26,"phoneExt":26,"email":37},"Claire Carette, MD",{"facility":163,"status":50,"city":152,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":164,"geoPoint":166,"contacts":167},"AP-HP - hôpital Bichat-Claude Bernard",{"type":55,"coordinates":165},[156,157],{"lat":157,"lon":156},[168],{"name":169,"role":42,"phone":26,"phoneExt":26,"email":170},"Boris Hansel, MD","boris.hansel@aphp.fr",{"facility":172,"status":50,"city":152,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":173,"geoPoint":175,"contacts":176},"AP-HP - hôpital de la Pitié-Salpêtrière",{"type":55,"coordinates":174},[156,157],{"lat":157,"lon":156},[177],{"name":178,"role":42,"phone":26,"phoneExt":26,"email":179},"Judith Aron-Wisnewsky, MD","judith.aron-wisnewsky@aphp.fr",{"facility":181,"status":50,"city":152,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":182,"geoPoint":184,"contacts":185},"Institut Mutualiste Montsouris",{"type":55,"coordinates":183},[156,157],{"lat":157,"lon":156},[186],{"name":187,"role":42,"phone":26,"phoneExt":26,"email":188},"Guillaume Pourcher, MD","guillaume.pourcher@imm.fr",{"facility":190,"status":50,"city":191,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"HCL - centre hospitalier Lyon-Sud","Pierre-Bénite",{"type":55,"coordinates":193},[194,195],4.82424,45.70359,{"lat":195,"lon":194},[198],{"name":199,"role":42,"phone":26,"phoneExt":26,"email":200},"Emmanuel Disse, MD","emmanuel.disse@chu-lyon.fr",{"facility":202,"status":203,"city":204,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":205,"geoPoint":209,"contacts":210},"CH de Saint-Denis - hôpital Delafontaire","NOT_YET_RECRUITING","Saint-Denis",{"type":55,"coordinates":206},[207,208],2.35387,48.93564,{"lat":208,"lon":207},[211],{"name":212,"role":42,"phone":26,"phoneExt":26,"email":213},"Jean-Marc Catheline, MD","jeanmarc.catheline@ch-stdenis.fr",{"facility":215,"status":50,"city":216,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"CHU de Toulouse - hôpital Larrey","Toulouse",{"type":55,"coordinates":218},[219,220],1.44367,43.60426,{"lat":220,"lon":219},[223],{"name":224,"role":42,"phone":26,"phoneExt":26,"email":225},"Patrick Ritz, MD","ritz.p@chu-toulouse.fr",{"type":227,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[229],{"name":230,"class":231},"Ministry of Health, France","OTHER_GOV","100407132","phase-3-extending-time-without-diabetes-after-bariatric-surgery-a-trial-comparing-the-metformin-addition-or-not-to-standard-care-100407132",false,"NCT04581447","Extending Time Without Diabetes After Bariatric Surgery: a Trial Comparing the Metformin Addition or Not to Standard Care","Extending Time Without Diabetes After Bariatric Surgery: a Randomized Controlled Trial Comparing the Metformin Addition or Not to Standard Care","DiabOUT","Inclusion Criteria:\n\n* Adults 18-70 years old\n* Having undergone gastric bypass or sleeve gastrectomy 12 to 36 +\u002F-3 months before inclusion\n* \"ex-T2D\" treated with at least one anti-diabetic drug before bariatric surgery or HbA1c ≥ 6.5 % before bariatric surgery\n* HbA1C \\\u003C 6.5 % at inclusion with no anti-hyperglycemic medications for the last three months\n* Written consent\n\nExclusion Criteria:\n\n* Known type 1 diabetes\n* Pregnancy and breastfeeding\n* Estimated glomerular filtration rate\\\u003C44 ml\u002Fmin (MDRD)\n* Known intolerance to metformin\n* Known contraindication to metformin:\n\n  * Acute metabolic acidosis\n  * Acute affection which could lead to renal deterioration (ex: dehydration, serious infection, shock, intravascular administration of iodinated contrast agent within the last 48 hours)\n  * Acute or chronic disease which could lead to a tissue hypoxia (ex : severe cardiac insufficiency, severe respiratory insufficiency, myocardial infarction within the last 3 months, shock)\n  * Hepatocellular insufficiency\n  * Prothrombin ratio ≤ 50%\n  * SGOT or SGPT levels ≥ 10 times the upper limits of the normal range\n  * Alcohol use disorder\n* Medications and medical conditions likely to confound the assessment of diabetes:\n\n  * glucocorticoids treatment\n  * renal graft\n  * Cushing's syndrome\n  * acromegaly\n  * fasting plasma triglyceride \\> 600 mg\u002Fdl despite treatment\n* Patient under legal protection","ALL","18 Years","70 Years",{"count":244,"type":245},126,"ESTIMATED","INTERVENTIONAL",[248],"PHASE3","This study is a randomized trial that evaluates the effect of metformin addition or not to standard care on the duration of diabetes remission after bariatric surgery.",[251,252,23],"Diabetes","Bariatric Surgery",[251,252,254,255,23],"Sleeve gastrectomy","Gastric bypass","2023-06-07",{"date":258,"type":259},"2023-06-08","ACTUAL",{"date":261,"type":259},"2021-01-07",{"date":263,"type":245},"2026-11",{"name":5,"class":6},16]