Extending time without diabetes after bariatric surgery: a randomized controlled trial comparing the metformin addition or not to standard care
- Conditions
- Type 2 Diabetes complete remission after Bariatric surgery under antidiabetic drugTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Registration Number
- EUCTR2019-000312-28-FR
- Lead Sponsor
- APHP / DRCI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 350
-Adults 18-70 years-old
-Having undergone gastric bypass or sleeve gastrectomy 12 to 24 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-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)
oAcute or chronic disease which could lead to a tissue hypoxia (ex : cardiac insufficiency, respiratory insufficiency, latest myocardial infarction, shock)
oHepatocellular insufficiency
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method