Study comparing a metformin treatment to standard care to extend time without diabetes after bariatric surgery
- Conditions
- Type 2 Diabetes complete remission after bariatric surgery under antidiabetic drug
- Registration Number
- 2024-516409-22-00
- Lead Sponsor
- Assistance Publique Hopitaux De Paris
- Brief Summary
To demonstrate that metformin increases the proportion of patients with T2D remission compared to standard care among ex-T2D patients operated of BS, after a 3-year period of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 126
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
Known type 1 diabetes
Pregnancy and breastfeeding
Estimated glomerular filtration rate ≤44 ml/min (MDRD)
Known intolerance to metformin
Known contraindication to metformin: o Acute metabolic acidosis o Acute affection which could lead to renal deterioration (ex: dehydration, serious infection, shock, intravascular administration of iodinated contrast agent within the last 48 hours) o 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) o Hepatocellular insufficiency o Prothrombin ratio ≤ 50% o SGOT or SGPT levels ≥ 10 times the upper limits of the normal range o Alcohol use disorder
Medications and medical conditions likely to confound the assessment of diabetes: o glucocorticoids treatment o renal graft o Cushing’s syndrome o acromegaly o fasting 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 Proportion of patients with partial or complete T2D remission criteria at three years in T2D patients operated of BS (GB or SG). Criteria for diabetes remission assessment will be used as described in 2012 in the American Diabetes Association guidelines (8,9): - Complete remission: HbA1c<5.7% and no anti-diabetic medication (except metformin in the experimental group). - Partial remission: HbA1c<6.5% and no anti-diabetic medication (except metformin in the experimental group). Proportion of patients with partial or complete T2D remission criteria at three years in T2D patients operated of BS (GB or SG). Criteria for diabetes remission assessment will be used as described in 2012 in the American Diabetes Association guidelines (8,9): - Complete remission: HbA1c<5.7% and no anti-diabetic medication (except metformin in the experimental group). - Partial remission: HbA1c<6.5% and no anti-diabetic medication (except metformin in the experimental group).
- Secondary Outcome Measures
Name Time Method Proportion of patients with T2D partial or complete remission criteria at 1 and 2 years Proportion of patients with T2D partial or complete remission criteria at 1 and 2 years
Proportion of patients with strict complete remission at 3 years Proportion of patients with strict complete remission at 3 years
Percentage of weight and BMI change at 1,2 and 3 years compared to baseline Percentage of weight and BMI change at 1,2 and 3 years compared to baseline
Level of cardio-metabolic parameters associated to T2D (fasting glycaemia and insulinemia, HOMA-IR, triglycerides and HDL cholesterol, blood pressure) at 1,2 and 3 years compared to baseline Level of cardio-metabolic parameters associated to T2D (fasting glycaemia and insulinemia, HOMA-IR, triglycerides and HDL cholesterol, blood pressure) at 1,2 and 3 years compared to baseline
Level of nutritional parameters associated with BS (albumin, hemoglobin, iron, serum ferritin, transferrin saturation, calcium, vitamins D and B1, B9, B12) at 1,2 and 3 years compared to baseline Level of nutritional parameters associated with BS (albumin, hemoglobin, iron, serum ferritin, transferrin saturation, calcium, vitamins D and B1, B9, B12) at 1,2 and 3 years compared to baseline
Proportion of adverse drug reactions in the intervention group compared to standard care all along the trial (all visits) Proportion of adverse drug reactions in the intervention group compared to standard care all along the trial (all visits)
Adherence level in the intervention group as measured using pill counts (defined as taking at least 80% of assigned study pills in the intervention group) (all visits) and metformin plasmatic dosage at 1,2 and 3 years in sites that can perform it Adherence level in the intervention group as measured using pill counts (defined as taking at least 80% of assigned study pills in the intervention group) (all visits) and metformin plasmatic dosage at 1,2 and 3 years in sites that can perform it
Number and level of retinopathy, nephropathy and macroangiopathy events at 3 years Number and level of retinopathy, nephropathy and macroangiopathy events at 3 years
Quality of life changes assessed by EQ5D auto-questionnaire from baseline to 1, 2 and 3 years Quality of life changes assessed by EQ5D auto-questionnaire from baseline to 1, 2 and 3 years
5y-Ad-Diarem score calculated with baseline data (inclusion) to assess clinical outcome at the end of the study 5y-Ad-Diarem score calculated with baseline data (inclusion) to assess clinical outcome at the end of the study
Changes in fecal microbiota (diversity, composition and function) from baseline at 1 and 3 years Changes in fecal microbiota (diversity, composition and function) from baseline at 1 and 3 years
Trial Locations
- Locations (9)
Assistance Publique Hopitaux De Paris
🇫🇷Paris, France
Centre Hospitalier Regional De Marseille
🇫🇷Marseille, France
Centre Hospitalier Universitaire De Bordeaux
🇫🇷Pessac, France
Hospices Civils De Lyon
🇫🇷Pierre Benite, France
Centre Hospitalier Universitaire De Toulouse
🇫🇷Toulouse, France
Centre Hospitalier Universitaire Amiens Picardie
🇫🇷Amiens, France
Centre Hospitalier Universitaire De Lille
🇫🇷Lille Cedex, France
Institut Mutualiste Montsouris
🇫🇷Paris, France
Centre Hospitalier Intercommunal Creteil
🇫🇷Creteil, France
Assistance Publique Hopitaux De Paris🇫🇷Paris, FranceMarion BRETAULTSite contact+33149095587marion.bretault@aphp.frJudith ARON-WISNEWSKYSite contact+33142177541judith.aron-wisnewsky@aphp.frHélène BIHANSite contact+33148955151helene.bihan@aphp.frBoris HANSELSite contact+33140258735boris.hansel@aphp.frSéverine LEDOUXSite contact+3314760256severine.ledoux@aphp.frClaire CARETTESite contact+33156095521claire.carette@aphp.fr