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

• Status: Recruiting
• Trial end date: 2026-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Ministry of Health, France
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Adults 18-70 years old

• Having undergone gastric bypass or sleeve gastrectomy 12 to 24 +/-3 months before inclusion

• "ex-T2D" treated with at least one anti-diabetic drug 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