Impact of the Length of Biliopancreatic Limb on Diabetes Associated With the Changes in Incretin Hormone and Gut Microbiota Following Distal Gastrectomy in Patients With Gastric Cancer and Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- diabetes remission rate (%)
研究概览
简要总结
This is a prospective, randomized controlled trial to investigate the impact of a long biliopancreatic limb of Roux-en-Y reconstruction on diabetes control in patients with concurrent type 2 diabetes and gastric cancer
详细描述
The present study aimed to compare the changes in glucose metabolism and incretin hormone responses following long-limb bypass Roux-en-Y reconstruction with different biliopancreatic limb lengths after distal gastrectomy in gastric cancer patients with type 2 diabetes. This is a prospective, single-center, randomized controlled trial. Patients diagnosed with stage I gastric cancer and type 2 diabetes are eligible for the present study. Patients who will undergo laparoscopic distal gastrectomy for cancer located at the lower two-thirds of the stomach will only be included.
The reconstruction method will be randomly assigned among long-Roux limb Roux-en-Y (with 100 cm-long Roux limb & 50cm-long biliopancreatic limb) or long-biliopancreatic limb Roux-en-Y (with 50 cm-long Roux limb & 100cm-long biliopancreatic limb) reconstruction methods.
All the patients are subjected to a 75g-oral glucose tolerance test (OGTT) preoperatively, and at 3 months, 6 months postoperatively, and serum glucose, as well as incretin hormones, will be serially measured. Fecal samples will be obtained preoperatively and at 3 months after surgery for gut microbiota analyses.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with type 2 diabetes as well as pathologically proven gastric cancer of clinical stage I according to the AJCC 8th edition
- •Those who are expected to undergo laparoscopic distal gastrectomy
排除标准
- •baseline fasting C-peptide level < 1.0 ng/dL (who had the possibility of type 1 diabetes)
- •previous radiotherapy or surgery at upper abdomen other than laparoscopic cholecystectomy
- •other malignancies in recent 5 years
- •vulnerable patients (pregnant women, those with cognitive impairment, etc)
- •ECOG-PS ≥ 2
- •participating in other clinical trials within 6 months
结局指标
主要结局
diabetes remission rate (%)
时间窗: 6 months
rate of the patients with HbA1c \< 6.5% without medication
次要结局
- delta HbA1c (%)(6 months)
- changes in body fat mass (kg)(up to 6 months)
- changes in lean body mass (kg)(up to 6 months)
- changes in dynamic incretin hormone secretion(up to 6 months)
- changes in body mass index (BMI, kg/m2)(up to 6 months)
- changes in blood glucose and insulin concentration(up to 6 months)
- changes in gut microbiota(before & at 3 months after surgery)
研究者
Ji Yeon Park
Ji Yeon Park
Kyungpook National University Chilgok Hospital