Clinical trial NCT04889859: Impact of Biliopancreatic Limb Length on Diabetes Following Distal Gastrectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stomach Neoplasm
Diabetes Mellitus, Type 2
Keywords: incretin
Lead sponsor: Kyungpook National University Chilgok Hospital
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: diabetes remission rate (%)
timeFrame: 6 months
Secondary outcomes:
measure: delta HbA1c (%)
timeFrame: 6 months
measure: changes in body mass index (BMI, kg/m2)
timeFrame: up to 6 months
measure: changes in body fat mass (kg)
timeFrame: up to 6 months
measure: changes in lean body mass (kg)
timeFrame: up to 6 months
measure: changes in blood glucose and insulin concentration
timeFrame: up to 6 months
measure: changes in dynamic incretin hormone secretion
timeFrame: up to 6 months
measure: changes in gut microbiota
timeFrame: before & at 3 months after surgery
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
Study officials:
affiliation: Kyungpook National University Chilgok Hospital
name: Ji Yeon Park, MD
role: PRINCIPAL_INVESTIGATOR
References: