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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Known type 1 diabetes

Pregnancy and breastfeeding

Estimated glomerular filtration rate<44 ml/min (MDRD)

Known intolerance to metformin

Trial design

Treatments tested in this trial

  • Metformin
  • Standard Care
  • Standardized meal

Treatment groups

126 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Ministry of Health, France

Collaborator