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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
After standard laparoscopic distal gastrectomy with radical lymphadenectomy, the gastrointestinal continuity will be restored with Roux-en-Y reconstruction using 100 cm-long Roux limb and 50 cm-long biliopancreatic limb.
After standard laparoscopic distal gastrectomy with radical lymphadenectomy, the gastrointestinal continuity will be restored with Roux-en-Y reconstruction using 50 cm-long Roux limb and 100 cm-long biliopancreatic limb.
Kyungpook National University Chilgok Hospital
Daegu, South Korea
diabetes remission rate (%)
rate of the patients with HbA1c \< 6.5% without medication
Time frame: 6 months
delta HbA1c (%)
difference of preoperative HbA1c and postoperative HbA1c
Time frame: 6 months
changes in body mass index (BMI, kg/m2)
difference of preoperative BMI and postoperative BMI
Time frame: up to 6 months
changes in body fat mass (kg)
difference in body fat mass measured by bioimpedance analysis
Time frame: up to 6 months
changes in lean body mass (kg)
difference in lean body mass measured by bioimpedance analysis
Time frame: up to 6 months
changes in blood glucose and insulin concentration
changes in dynamic blood glucose and insulin levels up to 2 hours after 75g - oral glucose challenge
Time frame: up to 6 months
changes in dynamic incretin hormone secretion
changes in dynamic GLP-1 and GIP secretion up to 2 hours after 75g oral glucose challenge
Time frame: up to 6 months
changes in gut microbiota
gut microbiota analysis from the fecal samples
Time frame: before & at 3 months after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.