Study comparing a metformin treatment to standard care to extend time without diabetes after bariatric surgery

Phase 1

Conditions: Type 2 Diabetes complete remission after bariatric surgery under antidiabetic drug
MedDRA version: 20.0Level: LLTClassification code: 10012594Term: Diabetes Class: 10027433
MedDRA version: 20.0Level: SOCClassification code: 10014698Term: Endocrine disorders Class: 5
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: CTIS2024-516409-22-00

Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 126

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: 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