Type 2 Diabetes complete remission after Bariatric surgery under antidiabetic drug
Conditions
Interventions
Trade Name: METFORMINE 850 mg, comprimé pelliculé
Product Name: METFORMINE 850 mg
Pharmaceutical Form: Coated tablet
INN or Proposed INN: METFORMIN
CAS Number: 657-24-9
Other descriptive name: Metform
Sponsors
APHP / DRCI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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: o Acute metabolic acidosis o Acute affection which could lead to renal deterioration (ex: dehydration, serious infection, shock, intravascular administration of iodinated contrast agent) o Acute or chronic disease which could lead to a tissue hypoxia (ex : cardiac insufficiency, respiratory insufficiency, latest myocardial infarction, shock) o Hepatocellular insufficiency 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: -To assess the proportion of patients with T2D partial or complete remission with metformin compared to standard care in ex-T2D patients operated of BS, after 1 and 2 years of treatment. -To assess body weight and metabolic parameters in metformin group versus standard care. -To assess tolerance, nutritional status and adherence to metformin in intervention group versus standard care. -To assess micro and macroangiopathy at 3 years. -To assess quality of life changes from baseline at 1, 2 and 3 years. -To assess the accuracy of long term prediction score (i.e. prolonged remission assessed at the end of the study with the Ad-DiaRem score) -To explore gut microbiota differences (diversity, composition and function) between metformin treated and non-treated individuals ;Primary end point(s): 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). ;Timepoint(s) of evaluation of this end point: LSLV | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - 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 - 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 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) - 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 - 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 - 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 ;Timepoint(s) of evaluation of this end point: LSLV | — |
Countries
France
Contacts
Public ContactProject Manager
APHP/DRCI
Outcome results
None listed