Type 2 DiabetesNCT02667652
The Curative Effect of the Length of the Jejunum Exclusion in Grstric Bypass Surgery for Type 2 Diabetes
A study testing short biliarypancreatic limb and long biliarypancreatic limb in people with Type 2 Diabetes and Obesity, run by Weidong Tong at 1 site in China.
Trial summary
The purpose of this study is to investigate the curative effect of the length of the jejunum exclusion in gastric surgry for T2DM and metabolic syndrome,and to draft Scientific and reasonable operation parameters. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- short biliarypancreatic limb and long biliarypancreatic limb
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Aug 2020
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 20-65 years old
- History of diabetes is less than 15 years
- Fasting c-peptide≥1.6
- BMI≥21kg/m2；
- Ability to understand the nature of the procedure and willing to follow postoperative routine lifestyle and checkups
Who cannot join
- Psychological and mental disorders
- Serious important organs such as heart and lung disease cannot be tolerated surgery
- Complex history of abdominal surgery in the abdominal cavity adhesion
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Curative Effect of the Length of the Jejunum Exclusion in Grstric Bypass Surgery for Type 2 Diabetes:a Randomized Controlled Trials
The purpose of this study is to investigate the curative effect of the length of the jejunum exclusion in gastric surgry for T2DM and metabolic syndrome,and to draft Scientific and reasonable operation parameters.
Read the detailed description
Currently, there is a growing evidence supports the efficacy of Roux-en-Y gastric bypass for the treatment of Type 2 diabetes mellitus. However,there still have a great controversy about the operation parameters. With randomized controlled trial, Patients of BMI>21kg/m2 with type 2 diabetes were randomly divided into two groups: short biliarypancreatic limb:50cm;long biliarypancreatic limb :100cm. The investigators followed-up 3,6,12,24 months of the change of BMI,FBG,HbA1c,Blood pressure,Blood fat after surgery.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- short biliarypancreatic limb, long biliarypancreatic limb
- Keywords
- T2DM, RYGB, RCT
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short biliarypancreatic limbProcedure or surgery
biliarypancreatic limb:50cm;roux limb:150cm.
long biliarypancreatic limbProcedure or surgery
biliarypancreatic limb:100cm;roux limb:100cm.
| Study group | Role | What they receive |
|---|---|---|
| short biliarypancreatic limb | Active comparator | short biliarypancreatic limb Receives: Procedure: short biliarypancreatic limb |
| long biliarypancreatic limb | Active comparator | long biliarypancreatic limb Receives: Procedure: long biliarypancreatic limb |
What is being measured
The primary outcome is the main question the study is designed to answer.
body mass idex
Changesd of BMI
Measured: 24 months
Secondary outcomes (4)
IFG
Variations of IFG
Measured: 24 months
HbA1c
The changes of HbA1c
Measured: 24 months
blood pressure
Changes of blood pressure including both systolic and diastolic pressure.
Measured: 24 months
blood fat
Changes of blood fat including LDL, HDL, CHOL, TG
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2019
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weidong Tong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Weidong Tong, Third Military Medical University
- Investigators
- Tong Weidong, Professor, Principal investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667652
- Sponsor's protocol ID
- 776117
- Status last verified
- May 2022
- First submitted
- 26 Jan 2016
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Ethics Committee of Daping Hospital
Publications
Shi Z. Prevalence of diabetes among men and women in China. N Engl J Med. 2010 Jun 24;362(25):2425; author reply 2426. doi: 10.1056/NEJMc1004671. No abstract available.
PubMed 20573933Mingrone G, Panunzi S, De Gaetano A, Guidone C, Iaconelli A, Leccesi L, Nanni G, Pomp A, Castagneto M, Ghirlanda G, Rubino F. Bariatric surgery versus conventional medical therapy for type 2 diabetes. N Engl J Med. 2012 Apr 26;366(17):1577-85. doi: 10.1056/NEJMoa1200111. Epub 2012 Mar 26.
PubMed 22449317Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, Thomas S, Abood B, Nissen SE, Bhatt DL. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012 Apr 26;366(17):1567-76. doi: 10.1056/NEJMoa1200225. Epub 2012 Mar 26.
PubMed 22449319Gleysteen JJ. Five-year outcome with gastric bypass: Roux limb length makes a difference. Surg Obes Relat Dis. 2009 Mar-Apr;5(2):242-7; discussion 247-9. doi: 10.1016/j.soard.2008.08.005. Epub 2008 Aug 19.
PubMed 18996751Huang CK, Lee YC, Hung CM, Chen YS, Tai CM. Laparoscopic Roux-en-Y gastric bypass for morbidly obese Chinese patients: learning curve, advocacy and complications. Obes Surg. 2008 Jul;18(7):776-81. doi: 10.1007/s11695-007-9373-y. Epub 2008 May 16.
PubMed 18483835
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Curative Effect of the Length of the Jejunum Exclusion in Grstric Bypass Surgery for Type 2 Diabetes:a Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT02667652
- Acronym / sponsor ID
- 776117
- Conditions
- Type 2 Diabetes, Obesity
- Keywords
- T2DM, RYGB, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Weidong TongUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 29 Jan 2016 (estimated)
- 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.
The purpose of this study is to investigate the curative effect of the length of the jejunum exclusion in gastric surgry for T2DM and metabolic syndrome,and to draft Scientific and reasonable operation parameters.
Detailed description
Currently, there is a growing evidence supports the efficacy of Roux-en-Y gastric bypass for the treatment of Type 2 diabetes mellitus. However,there still have a great controversy about the operation parameters. With randomized controlled trial, Patients of BMI>21kg/m2 with type 2 diabetes were randomly divided into two groups: short biliarypancreatic limb:50cm;long biliarypancreatic limb :100cm. The investigators followed-up 3,6,12,24 months of the change of BMI,FBG,HbA1c,Blood pressure,Blood fat after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short biliarypancreatic limb | Active comparator | Procedure: short biliarypancreatic limbshort biliarypancreatic limb |
| long biliarypancreatic limb | Active comparator | Procedure: long biliarypancreatic limblong biliarypancreatic limb |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 20-65 years old
- History of diabetes is less than 15 years
- Fasting c-peptide≥1.6
- BMI≥21kg/m2；
- Ability to understand the nature of the procedure and willing to follow postoperative routine lifestyle and checkups
Key exclusion criteria (4 listed)
- Psychological and mental disorders
- Serious important organs such as heart and lung disease cannot be tolerated surgery
- Complex history of abdominal surgery in the abdominal cavity adhesion
- Pregnancy or lactation
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 |
|---|---|---|
| short biliarypancreatic limbbiliarypancreatic limb:50cm;roux limb:150cm. | Procedure or surgery | short biliarypancreatic limb |
| long biliarypancreatic limbbiliarypancreatic limb:100cm;roux limb:100cm. | Procedure or surgery | long biliarypancreatic limb |
Primary outcome
body mass idex
Time frame: 24 months
Changesd of BMI
4 secondary outcomes
IFG
Time frame: 24 months
HbA1c
Time frame: 24 months
blood pressure
Time frame: 24 months
blood fat
Time frame: 24 months
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 11 May 2022.
- Background: PubMed 20573933Shi Z. Prevalence of diabetes among men and women in China. N Engl J Med. 2010 Jun 24;362(25):2425; author reply 2426. doi: 10.1056/NEJMc1004671. No abstract available.
- Background: PubMed 22449317Mingrone G, Panunzi S, De Gaetano A, Guidone C, Iaconelli A, Leccesi L, Nanni G, Pomp A, Castagneto M, Ghirlanda G, Rubino F. Bariatric surgery versus conventional medical therapy for type 2 diabetes. N Engl J Med. 2012 Apr 26;366(17):1577-85. doi: 10.1056/NEJMoa1200111. Epub 2012 Mar 26.
- Background: PubMed 22449319Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, Thomas S, Abood B, Nissen SE, Bhatt DL. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012 Apr 26;366(17):1567-76. doi: 10.1056/NEJMoa1200225. Epub 2012 Mar 26.
- Background: PubMed 18996751Gleysteen JJ. Five-year outcome with gastric bypass: Roux limb length makes a difference. Surg Obes Relat Dis. 2009 Mar-Apr;5(2):242-7; discussion 247-9. doi: 10.1016/j.soard.2008.08.005. Epub 2008 Aug 19.
- Background: PubMed 18483835Huang CK, Lee YC, Hung CM, Chen YS, Tai CM. Laparoscopic Roux-en-Y gastric bypass for morbidly obese Chinese patients: learning curve, advocacy and complications. Obes Surg. 2008 Jul;18(7):776-81. doi: 10.1007/s11695-007-9373-y. Epub 2008 May 16.
- Individual participant dataSharing planned: No. Ethics Committee of Daping Hospital
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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.
Tong Weidong, Professor principal investigator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing short biliarypancreatic limb and long biliarypancreatic limb in people with Type 2 Diabetes and Obesity, run by Weidong Tong at 1 site in China.
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 5 inclusion and 4 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 11 May 2022. 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 China. 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?
body mass idex (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02667652, which also lists 5 linked publications.
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 11 May 2022.