Efficacy and Safety of One-anastomosis Versus Roux-en-Y Gastric Bypass for Type 2 Diabetes Remission
NCT ID: NCT05015283
Last Updated: 2022-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
248 participants
INTERVENTIONAL
2022-02-01
2026-12-31
Brief Summary
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In this study, two kinds of metabolic surgery will be compared. At present, focusing on the above two operations, only two effective randomized controlled clinical studies have been carried out, among which one single-center clinical study has been followed up for 2 years, and the primary end point is weight loss; Another multicenter study, with a 2-year follow-up, showed that the primary end point was weight loss, and the secondary index was the effectiveness of two surgical methods in the treatment of T2DM.There is still a lack of evidence-based evidence for the effectiveness and safety of the two surgical methods in the treatment of T2DM. This study will make high-level evidence about the advantages and disadvantages of OAGB and RYGB in the treatment of T2DM.
In this study, a number of centers with rich experience and clinical research experience in weight loss and metabolic surgery in Asia will be combined to complete the enrollment of 248 patients. Those who meet the standards will be randomly divided into two kinds of operations, and they will be followed up for 5 years on schedule. The rate of lost follow-up is controlled within 20%, and the data integrity is controlled within 95%. Taking the blood glucose remission rate of type 2 diabetes as the main observation index, the prospective verification shows that OAGB is clinically effective in treating obesity with type 2 diabetes compared with RYGB.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Laparoscopic One-anastomosis gastric bypass
In this group, the bariatric procedure is laparoscopic one-anastomosis gastric bypass, all operations follow the same standard operating procedure.
The laparoscopic One-anastomosis gastric bypass will consist of:
gastrointestinal anastomosis: anterior colon and posterior stomach gastrointestinal anastomosis size: diameter \< 1.5cm, linear anastomosis length 2.5cm biliary and pancreatic branches 200cm, food branches 100cm exact relationship with mesangial defect
Laparoscopic Roux-en-Y gastric bypass
In this group, the bariatric procedure is laparoscopic Roux-en-Y gastric bypass, all operations follow the same standard operating procedure.
The laparoscopic Roux-en-Y gastric bypass will consist of:
the laparoscopic Roux-en-Y gastric bypass gastric sac size \< 30ml gastrointestinal anastomosis: anterior colon and posterior stomach gastrointestinal anastomosis size: diameter \< 1.5cm, linear anastomosis length 2.5cm biliary and pancreatic branches 50cm, food branches 150cm exact relationship with mesangial defect
Interventions
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The laparoscopic One-anastomosis gastric bypass will consist of:
gastrointestinal anastomosis: anterior colon and posterior stomach gastrointestinal anastomosis size: diameter \< 1.5cm, linear anastomosis length 2.5cm biliary and pancreatic branches 200cm, food branches 100cm exact relationship with mesangial defect
The laparoscopic Roux-en-Y gastric bypass will consist of:
the laparoscopic Roux-en-Y gastric bypass gastric sac size \< 30ml gastrointestinal anastomosis: anterior colon and posterior stomach gastrointestinal anastomosis size: diameter \< 1.5cm, linear anastomosis length 2.5cm biliary and pancreatic branches 50cm, food branches 150cm exact relationship with mesangial defect
Eligibility Criteria
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Inclusion Criteria
* 50 kg/m2≥BMI≥27.5kg/m2
* Type 2 diabetes duration ≥6 months
* HbA1c≥7.0%
* Currently receiving one or more oral/injectable hypoglycemic drugs (insulin /glucagon-like peptide-1 receptor agonist)
* Recommendation for OAGB/RYGB evaluated by a multidisciplinary team
Exclusion Criteria
* Fasting C-peptide level lower than 1/2 normal minimum
* Active gastrointestinal ulcer is present
* Helicobacter pylori infection is present
* A history of serious cardiovascular and cerebrovascular diseases (myocardial infarction, stroke, etc.)
* A history of cirrhosis (Child-Pugh≥A)
* A history of chronic kidney disease (eGFR )\< 60 ml/min / 1.73 m2)
* Inflammatory bowel disease is present (ulcerative colitis, Crohn's disease)
* Chronic anemia is present, Hgb for male \<100g/L, for female \<90g/L
* A desire to conception during the study period
* Uncontrolled mental and psychological disorders are present
* Expected survival\<5 years of end-stage disease or previous/current malignant tumor
* Participated in clinical studies/trials that have the conflict of interest with the study
* Unable to understand, refuse to participate and sign the informed consent
* Gallstones require cholecystectomy
* Reflux esophagitis above grade A
18 Years
65 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
OTHER
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
OTHER
The Third Xiangya Hospital of Central South University
OTHER
The First Affiliated Hospital of Soochow University
OTHER
The Third People's Hospital of Chengdu
OTHER
Taipei Medical University Hospital
OTHER
Beijing Friendship Hospital
OTHER
Responsible Party
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Zhongtao Zhang
Director of general surgery, principal investigator
Principal Investigators
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Zhongtao Zhang, M.D.;Ph.D
Role: PRINCIPAL_INVESTIGATOR
Beijing Friendship Hospital
Locations
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Beijing Friendship Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Li M, Liu Y, Lee WJ, Shikora SA, Robert M, Wang W, Wong SKH, Kong Y, Tong DKH, Tan CH, Zeng N, Zhu S, Wang C, Zhang P, Gu Y, Bai R, Meng F, Mao Z, Zhao X, Wu L, Liu Y, Zhang S, Zhang P, Zhang Z. Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for type 2 diabetes remission (ORDER): protocol of a multicentre, randomised controlled, open-label, superiority trial. BMJ Open. 2022 Sep 29;12(9):e062206. doi: 10.1136/bmjopen-2022-062206.
Other Identifiers
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BFH-ORDER
Identifier Type: -
Identifier Source: org_study_id
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