Impact of Biliopancreatic Limb Length on Diabetes Following Distal Gastrectomy

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04889859
• Other study ID #: KNUCH 2019-04-004
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2023
• Source: Kyungpook National University Chilgok Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Stomach Neoplasm
• Stomach Neoplasms

Intervention

Procedure:
• long 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.
• long 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.

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University Chilgok Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diabetes remission rate (%)	rate of the patients with HbA1c < 6.5% without medication	6 months
Secondary	delta HbA1c (%)	difference of preoperative HbA1c and postoperative HbA1c	6 months
Secondary	changes in body mass index (BMI, kg/m2)	difference of preoperative BMI and postoperative BMI	up to 6 months
Secondary	changes in body fat mass (kg)	difference in body fat mass measured by bioimpedance analysis	up to 6 months
Secondary	changes in lean body mass (kg)	difference in lean body mass measured by bioimpedance analysis	up to 6 months
Secondary	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
Secondary	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
Secondary	changes in gut microbiota	gut microbiota analysis from the fecal samples	before & at 3 months after surgery