Impact of Biliopancreatic Limb Length on Diabetes Following Distal Gastrectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Stomach Neoplasm, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Procedure: long Roux limb Roux-en-Y reconstruction
* Procedure: long biliopancreatic limb Roux-en-Y reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: long RL group<br>long Roux limb Roux-en-Y reconstruction | Procedure: long Roux limb Roux-en-Y reconstruction<br>* 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.<br>|
| Experimental: long BPL group<br>long biliopancreatic limb Roux-en-Y reconstruction | Procedure: long biliopancreatic limb Roux-en-Y reconstruction<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diabetes remission rate (%) | rate of the patients with HbA1c < 6.5% without medication | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delta HbA1c (%) | difference of preoperative HbA1c and postoperative HbA1c | 6 months | 
| changes in body mass index (BMI, kg/m2) | difference of preoperative BMI and postoperative BMI | up to 6 months | 
| changes in body fat mass (kg) | difference in body fat mass measured by bioimpedance analysis | up to 6 months | 
| changes in lean body mass (kg) | difference in lean body mass measured by bioimpedance analysis | 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 | 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 | up to 6 months | 
| changes in gut microbiota | gut microbiota analysis from the fecal samples | before & at 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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incretin