Extending Time Without Diabetes After Bariatric Surgery: a Trial Comparing the Metformin Addition or Not to Standard Care (DiabOUT)
Diabetes, Bariatric Surgery, Metformin
About this trial
This is an interventional prevention trial for Diabetes focused on measuring Diabetes, Bariatric Surgery, Sleeve gastrectomy, Gastric bypass, Metformin
Eligibility Criteria
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
Sites / Locations
- CHU Amiens-Picardie - hôpital NordRecruiting
- AP-HP - hôpital Avicenne
- CHU de Bordeaux - hôpital Haut-LévêqueRecruiting
- AP-HP - hôpital Ambroise-ParéRecruiting
- AP-HP - hôpital Louis-MourierRecruiting
- Centre hospitalier intercommunal de CréteilRecruiting
- CHU de Lille - hôpital Claude HuriezRecruiting
- AP-HM - hôpital de la ConceptionRecruiting
- AP-HM - hôpital Nord
- AP-HP - hôpital européen Georges-PompidouRecruiting
- AP-HP - hôpital Bichat-Claude BernardRecruiting
- AP-HP - hôpital de la Pitié-SalpêtrièreRecruiting
- Institut Mutualiste MontsourisRecruiting
- HCL - centre hospitalier Lyon-SudRecruiting
- CH de Saint-Denis - hôpital Delafontaire
- CHU de Toulouse - hôpital LarreyRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Metformin + Standard care
Standard Care
The pharmacological treatment (Metformin) will start at dose of 850 mg once daily and, at one month, increased to 850 mg twice daily. The dosage will be adjusted if necessary because of gastrointestinal symptoms and information on dose change during follow-up will be collected Adherence to study medications will be assessed by pills count and plasmatic dosage (Metformin group). All participants will receive standardized lifestyle recommendations regularly during all the time of the study Lifestyle recommendations will be provided by a nutritionist/diabetologist every 6 months at each study visit and reinforced by dedicated consultations with a dietician and a physical activity coach as usually performed in each center. This follow-up will be standardized for each center and applied equally to patients of both groups. Ancillary study measuring metformin-induced enterohormones secretion will be performed on a subgroup of 30 patients randomized in this arm.
All participants will receive standardized lifestyle recommendations regularly during all the time of the study Lifestyle recommendations will be provided by a nutritionist/diabetologist every 6 months at each study visit and reinforced by dedicated consultations with a dietician and a physical activity coach as usually performed in each center. This follow-up will be standardized for each center and applied equally to patients of both groups. Ancillary study measuring metformin-induced enterohormones secretion will be performed on a subgroup of 30 patients randomized in this arm.