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

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.

Eligibility

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

Conditions3

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