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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Oct 5, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of adding a medication called metformin to standard care for patients who have had bariatric surgery, like gastric bypass or sleeve gastrectomy. The goal is to see if this combination can help people stay free from diabetes for a longer time after their surgery. The trial is currently looking for participants who are between 18 and 70 years old and have completed their surgery 12 to 36 months ago. Eligible participants should have had diabetes before their surgery but currently have normal blood sugar levels without taking diabetes medications.

If you decide to join the trial, you will receive either metformin along with your usual care or just the usual care alone. Throughout the study, your health will be closely monitored to see how well you respond to the treatment. It's important to note that certain health conditions, like type 1 diabetes or severe kidney problems, may prevent you from participating. This trial is a great opportunity to help researchers understand how to improve diabetes management after weight loss surgery, which could benefit many others in the future.

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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