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Impact of Biliopancreatic Limb Length on Diabetes Following Distal Gastrectomy

Primary Purpose

Stomach Neoplasm, Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
long Roux limb Roux-en-Y reconstruction
long biliopancreatic limb Roux-en-Y reconstruction
Sponsored by
Kyungpook National University Chilgok Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasm focused on measuring incretin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kyungpook National University Chilgok Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

long RL group

long BPL group

Arm Description

long Roux limb Roux-en-Y reconstruction

long biliopancreatic limb Roux-en-Y reconstruction

Outcomes

Primary Outcome Measures

diabetes remission rate (%)
rate of the patients with HbA1c < 6.5% without medication

Secondary Outcome Measures

delta HbA1c (%)
difference of preoperative HbA1c and postoperative HbA1c
changes in body mass index (BMI, kg/m2)
difference of preoperative BMI and postoperative BMI
changes in body fat mass (kg)
difference in body fat mass measured by bioimpedance analysis
changes in lean body mass (kg)
difference in lean body mass measured by bioimpedance analysis
changes in blood glucose and insulin concentration
changes in dynamic blood glucose and insulin levels up to 2 hours after 75g - oral glucose challenge
changes in dynamic incretin hormone secretion
changes in dynamic GLP-1 and GIP secretion up to 2 hours after 75g oral glucose challenge
changes in gut microbiota
gut microbiota analysis from the fecal samples

Full Information

First Posted
May 9, 2021
Last Updated
March 12, 2023
Sponsor
Kyungpook National University Chilgok Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04889859
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Chilgok Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasm, Diabetes Mellitus, Type 2
Keywords
incretin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
long RL group
Arm Type
Active Comparator
Arm Description
long Roux limb Roux-en-Y reconstruction
Arm Title
long BPL group
Arm Type
Experimental
Arm Description
long biliopancreatic limb Roux-en-Y reconstruction
Intervention Type
Procedure
Intervention Name(s)
long Roux limb Roux-en-Y reconstruction
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
long biliopancreatic limb Roux-en-Y reconstruction
Intervention Description
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.
Primary Outcome Measure Information:
Title
diabetes remission rate (%)
Description
rate of the patients with HbA1c < 6.5% without medication
Time Frame
6 months
Secondary Outcome Measure Information:
Title
delta HbA1c (%)
Description
difference of preoperative HbA1c and postoperative HbA1c
Time Frame
6 months
Title
changes in body mass index (BMI, kg/m2)
Description
difference of preoperative BMI and postoperative BMI
Time Frame
up to 6 months
Title
changes in body fat mass (kg)
Description
difference in body fat mass measured by bioimpedance analysis
Time Frame
up to 6 months
Title
changes in lean body mass (kg)
Description
difference in lean body mass measured by bioimpedance analysis
Time Frame
up to 6 months
Title
changes in blood glucose and insulin concentration
Description
changes in dynamic blood glucose and insulin levels up to 2 hours after 75g - oral glucose challenge
Time Frame
up to 6 months
Title
changes in dynamic incretin hormone secretion
Description
changes in dynamic GLP-1 and GIP secretion up to 2 hours after 75g oral glucose challenge
Time Frame
up to 6 months
Title
changes in gut microbiota
Description
gut microbiota analysis from the fecal samples
Time Frame
before & at 3 months after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji Yeon Park, MD
Organizational Affiliation
Kyungpook National University Chilgok Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Biliopancreatic Limb Length on Diabetes Following Distal Gastrectomy

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