DIABOUT - Extending time without diabetes after bariatric surgery: a randomized controlled trial comparing the metformin addition or not to standard care
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 9
- 主要终点
- 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).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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).
次要结局
- 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 in sites that can perform it
- 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
研究者
Pr Claire CARETTE
Scientific
Assistance Publique Hopitaux De Paris