Diabetes Mellitus, Type 2, Stomach Neoplasm
Conditions
Keywords
incretin
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.
Interventions
PROCEDURElong Roux limb Roux-en-Y reconstruction
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.
PROCEDURElong biliopancreatic limb Roux-en-Y reconstruction
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.
Sponsors
Kyungpook National University Chilgok Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
1. baseline fasting C-peptide level \< 1.0 ng/dL (who had the possibility of type 1 diabetes) 2. previous radiotherapy or surgery at upper abdomen other than laparoscopic cholecystectomy 3. other malignancies in recent 5 years 4. vulnerable patients (pregnant women, those with cognitive impairment, etc) 5. ECOG-PS ≥ 2 6. participating in other clinical trials within 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diabetes remission rate (%) | 6 months | rate of the patients with HbA1c \< 6.5% without medication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in body mass index (BMI, kg/m2) | up to 6 months | difference of preoperative BMI and postoperative BMI |
| 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 |
| delta HbA1c (%) | 6 months | difference of preoperative HbA1c and postoperative HbA1c |
| 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 gut microbiota | before & at 3 months after surgery | gut microbiota analysis from the fecal samples |
| 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 |
Countries
South Korea
Outcome results
None listed