Impact of Long Alimentary Limb or Long Biliary Limb Roux-en-Y Gastric Bypass on Type 2 Diabetes Remission in Severely Obese Patients. A Prospective, Multicentric, Randomized, Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 396
- 试验地点
- 8
- 主要终点
- Rate of type 2 diabetes remission
研究概览
简要总结
In patients with type 2 diabetes, Roux-en-Y gastric bypass (RYGB), which excludes a portion of the stomach and the proximal intestine from the alimentary circuit, improves glucose metabolism more rapidly and more extensively than is expected from weight loss. The mechanisms of this unique effect of gastrointestinal exclusion appear to be complex and have not yet been clarified. A recent study unveil that intestinal uptake of ingested glucose is diminished by RYGB and restricted to the common limb, where food meets bile and other digestive fluids, resulting in an overall decrease of post prandial blood glucose excursion. the hypothesize that reducing the length of the common limb, which is rarely measured and highly variable in clinical practice, may significantly affect the metabolic outcome of gastrointestinal surgical procedures. The aim of the present study is to compare the impact of two variants of Roux-en-Y gastric bypass with a short common limb, the long alimentary limb or the long biliary limb Roux-en-Y gastric bypass, on type 2 diabetes remission in severely obese patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≥ 35 kg/m2
- •All patient with type 2 diabetes
- •Patients who were candidates for obesity surgery in accordance with French recommendation
排除标准
- •Severe cognitive or mental disorders
- •patient who have already undergone obesity surgery
- •Severe and non-stabilised eating disorders
- •The likely inability of the patient to participate in lifelong medical follow-up
- •Alcohol or psychoactive substances dependence
- •The absence of identified prior medical management of obesity
- •Diseases that are life-threatening in the short and medium term;
- •Contraindications to general anaesthesia.
结局指标
主要结局
Rate of type 2 diabetes remission
时间窗: at 12 months after surgery
HbA1c \< 6.5% AND fasting blood glucose \< 7.0 mmol/L in absence of antidiabetic drug
次要结局
- Absolute weight loss (aWL in kg)(at 1, 3, 6 and 12 months after surgery)
- Excess Weight Loss percentage (EWL%)(at 1, 3, 6 and 12 months after surgery)
- Excess BMI Loss percentage (EBL%)(at 1, 3, 6 and 12 months after surgery)
- Patient's quality of life score according to the Gastrointestinal Quality of Life Index (GIQLI) questionnaire adapted to bariatric surgery.(Before surgery and at 12 after surgery)
- Medical and surgical complication rates(During the month following surgery (for early complications) and from one month to 12 months postoperatively (for late complications)])
- Type and severity of early and late complications for each procedure(During the month following surgery (for early complications) and from one month to 12 months postoperatively (for late complications)])
- Change in glucose homeostasis(Before surgery and at 3, 6 and 12 months after surgery)
- Change in HbA1c(Before surgery and at 3, 6 and 12 months after surgery)
- Patient's quality of life score according to the Impact of Weight on Quality of Life (IWQOL) questionnaire(Before surgery and at 12 after surgery)
- Changes in blood lipids profile(Before surgery and at 1, 3, 6 and 12 months after surgery)
- Change in fasting glycemia(Before surgery and at 3, 6 and 12 months after surgery)
- changes in fasting insulinemia(Before surgery and at 3, 6 and 12 months after surgery)
- change in fasting c-peptide(Before surgery and at 3, 6 and 12 months after surgery)
- Number of antidiabetic treatments(Before surgery and at 3, 6 and 12 months after surgery)
- change in prealbumin levels(Before surgery and at 1, 3, 6 and 12 months after surgery)
- change in vitamins status assessment(Before surgery and at 1, 3, 6 and 12 months after surgery)