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NCT Number: NCT04889859

Impact of Biliopancreatic Limb Length on Diabetes Following Distal Gastrectomy

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

long Roux limb Roux-en-Y reconstruction

Procedure

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

Procedure

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 outcomes

  1. diabetes remission rate (%)

    Time frame: 6 months

    rate of the patients with HbA1c < 6.5% without medication

Secondary outcomes

  1. delta HbA1c (%)

    Time frame: 6 months

    difference of preoperative HbA1c and postoperative HbA1c

  2. changes in body mass index (BMI, kg/m2)

    Time frame: up to 6 months

    difference of preoperative BMI and postoperative BMI

  3. changes in body fat mass (kg)

    Time frame: up to 6 months

    difference in body fat mass measured by bioimpedance analysis

  4. changes in lean body mass (kg)

    Time frame: up to 6 months

    difference in lean body mass measured by bioimpedance analysis

  5. 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

  6. 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

  7. changes in gut microbiota

    Time frame: before & at 3 months after surgery

    gut microbiota analysis from the fecal samples

Sponsors and collaborators

Lead sponsor

Kyungpook National University Chilgok Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 17, 2021
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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