Stomach NeoplasmNCT04889859
Impact of Biliopancreatic Limb Length on Diabetes Following Distal Gastrectomy
A study testing long Roux limb Roux-en-Y reconstruction and long biliopancreatic limb Roux-en-Y reconstruction in people with Stomach Neoplasm and Diabetes Mellitus, Type 2, run by Kyungpook National University Chilgok Hospital at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stomach Neoplasm, Diabetes Mellitus, Type 2
- What is being tested?
- long Roux limb Roux-en-Y reconstruction and long biliopancreatic limb Roux-en-Y reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2019to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kyungpook National University Chilgok Hospital
Daegu, 41404
About this study
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
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
Read the 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.
- Conditions
- Stomach Neoplasm, Diabetes Mellitus, Type 2
- Being tested
- long Roux limb Roux-en-Y reconstruction, long biliopancreatic limb Roux-en-Y reconstruction
- Keywords
- incretin
- Medical subject headings
- Stomach Neoplasms, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
long Roux limb Roux-en-Y reconstructionProcedure or surgery
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 reconstructionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| long RL group | Active comparator | long Roux limb Roux-en-Y reconstruction Receives: Procedure: long Roux limb Roux-en-Y reconstruction |
| long BPL group | Experimental | long biliopancreatic limb Roux-en-Y reconstruction Receives: Procedure: long biliopancreatic limb Roux-en-Y reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
diabetes remission rate (%)
rate of the patients with HbA1c < 6.5% without medication
Measured: 6 months
Secondary outcomes (7)
delta HbA1c (%)
difference of preoperative HbA1c and postoperative HbA1c
Measured: 6 months
changes in body mass index (BMI, kg/m2)
difference of preoperative BMI and postoperative BMI
Measured: up to 6 months
changes in body fat mass (kg)
difference in body fat mass measured by bioimpedance analysis
Measured: up to 6 months
changes in lean body mass (kg)
difference in lean body mass measured by bioimpedance analysis
Measured: up to 6 months
changes in blood glucose and insulin concentration
changes in dynamic blood glucose and insulin levels up to 2 hours after 75g - oral glucose challenge
Measured: up to 6 months
changes in dynamic incretin hormone secretion
changes in dynamic GLP-1 and GIP secretion up to 2 hours after 75g oral glucose challenge
Measured: up to 6 months
changes in gut microbiota
gut microbiota analysis from the fecal samples
Measured: before & at 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 May 2019
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Chilgok Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Yeon Park, Kyungpook National University Chilgok Hospital
- Investigators
- Ji Yeon Park, MD, Principal investigator, Kyungpook National University Chilgok Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889859
- Sponsor's protocol ID
- KNUCH 2019-04-004
- Status last verified
- Mar 2023
- First submitted
- 9 May 2021
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04889859
- Acronym / sponsor ID
- KNUCH 2019-04-004
- Conditions
- Stomach Neoplasm, Diabetes Mellitus, Type 2
- Keywords
- incretin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kyungpook National University Chilgok HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| long RL group | Active comparator | Procedure: long Roux limb Roux-en-Y reconstructionlong Roux limb Roux-en-Y reconstruction |
| long BPL group | Experimental | Procedure: long biliopancreatic limb Roux-en-Y reconstructionlong biliopancreatic limb Roux-en-Y reconstruction |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| long Roux limb Roux-en-Y reconstructionAfter 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. | Procedure or surgery | long RL group |
| long biliopancreatic limb Roux-en-Y reconstructionAfter 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. | Procedure or surgery | long BPL group |
Primary outcome
diabetes remission rate (%)
Time frame: 6 months
rate of the patients with HbA1c < 6.5% without medication
7 secondary outcomes
delta HbA1c (%)
Time frame: 6 months
changes in body mass index (BMI, kg/m2)
Time frame: up to 6 months
changes in body fat mass (kg)
Time frame: up to 6 months
changes in lean body mass (kg)
Time frame: up to 6 months
changes in blood glucose and insulin concentration
Time frame: up to 6 months
changes in dynamic incretin hormone secretion
Time frame: up to 6 months
changes in gut microbiota
Time frame: before & at 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji Yeon Park, MD principal investigator
Kyungpook National University Chilgok Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing long Roux limb Roux-en-Y reconstruction and long biliopancreatic limb Roux-en-Y reconstruction in people with Stomach Neoplasm and Diabetes Mellitus, Type 2, run by Kyungpook National University Chilgok Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diabetes remission rate (%) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.