Impact of Biliopancreatic Limb Length on Diabetes Following Distal Gastrectomy

March 12, 2023 updated by: Ji Yeon Park, Kyungpook National University Chilgok Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 41404
        • Kyungpook National University Chilgok Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Chilgok Hospital

Investigators

  • Principal Investigator: Ji Yeon Park, MD, Kyungpook National University Chilgok Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

May 9, 2021

First Submitted That Met QC Criteria

May 12, 2021

First Posted (Actual)

May 17, 2021

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 12, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KNUCH 2019-04-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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