Impact of Biliopancreatic Limb Length on Diabetes Following Distal Gastrectomy
- Conditions
- Diabetes Mellitus, Type 2Stomach Neoplasm
- Interventions
- Procedure: long biliopancreatic limb Roux-en-Y reconstructionProcedure: long Roux limb Roux-en-Y reconstruction
- Registration Number
- NCT04889859
- Lead Sponsor
- Kyungpook National University Chilgok Hospital
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description long BPL group long biliopancreatic limb Roux-en-Y reconstruction long biliopancreatic limb Roux-en-Y reconstruction long RL group long Roux limb Roux-en-Y reconstruction long Roux limb Roux-en-Y reconstruction
- Primary Outcome Measures
Name Time Method diabetes remission rate (%) 6 months rate of the patients with HbA1c \< 6.5% without medication
- Secondary Outcome Measures
Name Time Method delta HbA1c (%) 6 months difference of preoperative HbA1c and postoperative HbA1c
changes in body fat mass (kg) up to 6 months difference in body fat mass measured by bioimpedance analysis
changes in lean body mass (kg) up to 6 months difference in lean body mass measured by bioimpedance analysis
changes in dynamic incretin hormone secretion up to 6 months changes in dynamic GLP-1 and GIP secretion up to 2 hours after 75g oral glucose challenge
changes in body mass index (BMI, kg/m2) up to 6 months difference of preoperative BMI and postoperative BMI
changes in blood glucose and insulin concentration up to 6 months changes in dynamic blood glucose and insulin levels up to 2 hours after 75g - oral glucose challenge
changes in gut microbiota before & at 3 months after surgery gut microbiota analysis from the fecal samples
Trial Locations
- Locations (1)
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Korea, Republic of