METFORMIN EMBONATE for Type 2 diabetes (post-bariatric surgery)

Inclusion criteria

• {"criterion_text":"- Adults 18-70 years-old\n- Having undergone gastric bypass or sleeve gastrectomy 12 to 36 ±3 months before inclusion\n- Ex-T2D treated with at least one anti-diabetic drug before bariatric surgery or HbA1c ≥ 6.5% before bariatric surgery\n- HbA1C < 6.5 % at inclusion with no anti-hyperglycemic medications for the last three months\n- Written consent"}

Exclusion criteria

• {"criterion_text":"- Known type 1 diabetes\n- Pregnancy and breastfeeding\n- Estimated glomerular filtration rate ≤44 ml/min (MDRD)\n- Known intolerance to metformin\n- Known contraindication to metformin: o\tAcute metabolic acidosis o\tAcute affection which could lead to renal deterioration (ex: dehydration, serious infection, shock, intravascular administration of iodinated contrast agent within the last 48 hours) o\tAcute 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\tHepatocellular insufficiency o\tProthrombin ratio ≤ 50% o\tSGOT or SGPT levels ≥ 10 times the upper limits of the normal range o\tAlcohol use disorder\n- Medications and medical conditions likely to confound the assessment of diabetes: o\tglucocorticoids treatment o\trenal graft o\tCushing’s syndrome o\tacromegaly o\tfasting plasma triglyceride > 600 mg/dl despite treatment\n- Patient under legal protection"}

Primary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Assessment per 2012 American Diabetes Association guidelines: Complete remission defined as HbA1c <5.7% with no anti-diabetic medication (except metformin allowed in experimental group); Partial remission defined as HbA1c <6.5% with no anti-diabetic medication (except metformin allowed in experimental group). Measured at 3 years."}

Secondary endpoints

• {"endpoint_text":"- Proportion of patients with T2D partial or complete remission criteria at 1 and 2 years\n- Proportion of patients with strict complete remission at 3 years\n- Percentage of weight and BMI change at 1,2 and 3 years compared to baseline\n- 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\n- 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\n- Proportion of adverse drug reactions in the intervention group compared to standard care all along the trial (all visits)\n- 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\n- Number and level of retinopathy, nephropathy and macroangiopathy events at 3 years\n- Quality of life changes assessed by EQ5D auto-questionnaire from baseline to 1, 2 and 3 years\n- 5y-Ad-Diarem score calculated with baseline data (inclusion) to assess clinical outcome at the end of the study\n- Changes in fecal microbiota (diversity, composition and function) from baseline at 1 and 3 years","definition_or_measurement_approach":"Secondary endpoints measured at specified timepoints (1, 2 and/or 3 years) as described: remission assessed by ADA criteria at 1 and 2 years; strict complete remission at 3 years; weight/BMI percent change vs baseline at 1/2/3 years; cardio-metabolic labs (fasting glucose, insulin, HOMA-IR, triglycerides, HDL, BP) at 1/2/3 years; nutritional lab panel at 1/2/3 years; adverse drug reactions recorded at all visits; adherence by pill counts (>=80% threshold) and plasma metformin when available at 1/2/3 years; retinopathy/nephropathy/macroangiopathy events summarized at 3 years; QoL by EQ-5D questionnaire at baseline and 1/2/3 years; 5y-Ad-DiaRem score calculated from baseline data; fecal microbiota diversity/composition/function changes at 1 and 3 years."}

France

Earliest CTIS Part Ii Submission Date

23-07-2024

Latest Decision Or Authorization Date

16-07-2025

Processing Time Days

358

Number Of Sites

13

Number Of Participants

126

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France