DIABOUT - Extending time without diabetes after bariatric surgery: a randomized controlled trial comparing the metformin addition or not to standard care - P170901J

Assistance Publique Hopitaux De Paris0 个研究点目标入组 126 人开始时间: 2024年7月16日最近更新: 2024年8月21日

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•Adults 18-70 years-old, Having undergone gastric bypass or sleeve gastrectomy 12 to 36 ±3 months before inclusion, Ex-T2D treated with at least one anti-diabetic drug before bariatric surgery or HbA1c = 6.5% before bariatric surgery, HbA1C < 6.5 % at inclusion with no anti-hyperglycemic medications for the last three months, Written consent

•Known type 1 diabetes, Pregnancy and breastfeeding, Estimated glomerular filtration rate =44 ml/min (MDRD), Known intolerance to metformin, Known contraindication to metformin: oAcute metabolic acidosis oAcute affection which could lead to renal deterioration (ex: dehydration, serious infection, shock, intravascular administration of iodinated contrast agent within the last 48 hours) oAcute 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) oHepatocellular insufficiency oProthrombin ratio = 50% oSGOT or SGPT levels = 10 times the upper limits of the normal range oAlcohol use disorder, Medications and medical conditions likely to confound the assessment of diabetes: oglucocorticoids treatment orenal graft oCushing’s syndrome oacromegaly ofasting plasma triglyceride > 600 mg/dl despite treatment, Patient under legal protection

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