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Extending Time Without Diabetes After Bariatric Surgery: a Trial Comparing the Metformin Addition or Not to Standard Care

RecruitingPhase 3Ages 18 Years - 70 YearsAllAssistance Publique - Hôpitaux de Paris
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * Known type 1 diabetes * Pregnancy and breastfeeding * Estimated glomerular filtration rate\<44 ml/min (MDRD) * Known intolerance to metformin * Known contraindication to metformin: * Acute metabolic acidosis * Acute affection which could lead to renal deterioration (ex: dehydration, serious infection, shock, intravascular administration of iodinated contrast agent within the last 48 hours) * 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) * Hepatocellular insufficiency * Prothrombin ratio ≤ 50% * SGOT or SGPT levels ≥ 10 times the upper limits of the normal range * Alcohol use disorder * Medications and medical conditions likely to confound the assessment of diabetes: * glucocorticoids treatment * renal graft * Cushing's syndrome * acromegaly * fasting plasma triglyceride \> 600 mg/dl despite treatment * Patient under legal protection
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What it tests

  • Metformin
  • Standard Care
  • Standardized meal
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Where

16 sites
CHU Amiens-Picardie - hôpital Nord
Amiens, France
AP-HP - hôpital Avicenne
Bobigny, France
CHU de Bordeaux - hôpital Haut-Lévêque
Bordeaux, France
AP-HP - hôpital Ambroise-Paré
Boulogne-Billancourt, France
AP-HP - hôpital Louis-Mourier
Colombes, France
Centre hospitalier intercommunal de Créteil
Créteil, France
CHU de Lille - hôpital Claude Huriez
Lille, France
AP-HM - hôpital de la Conception
Marseille, France

…and 8 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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