Extending Time Without Diabetes After Bariatric Surgery: a Trial Comparing the Metformin Addition or Not to Standard Care
Extending Time Without Diabetes After Bariatric Surgery: a Randomized Controlled Trial Comparing the Metformin Addition or Not to Standard Care
Assistance Publique - Hôpitaux de Paris
126 participants
Jan 7, 2021
INTERVENTIONAL
Conditions
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 Criteria5
- 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 Criteria19
- 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
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Interventions
Metformin will start at dose of 850 mg once daily and, at one month increased to 850 mg twice daily
Standard Care
Measurements of metformin-induced enterohormones secretion will be done after standardized meal test in a subgroup of patients (ancillary study)
Locations(16)
View Full Details on ClinicalTrials.gov
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NCT04581447