Efficacy and Safety of One-anastomosis Versus Roux-en-Y Gastric Bypass for Type 2 Diabetes Remission
Efficacy and Safety of One-anastomosis Versus Roux-en-Y Gastric Bypass for Type 2 Diabetes Remission (ORDER): a Multi-centric, Randomized, Open-label, Superiority Trial
Beijing Friendship Hospital
248 participants
Feb 1, 2022
INTERVENTIONAL
Conditions
Summary
Diabetes mellitus (T2DM) is the most common complication of obesity patients. According to previous literature reports, weight loss and metabolic surgery are powerful means to treat obesity complicated with T2DM. Roux-en-Y gastric bypass (RYGB) is the standard operation recommended by the international society. One-anastomosis gastric bypass (OAGB) was recommended by IFSO（the International Federation for the Surgery of OBESITY AND METABOLIC DISORDERS ） in 2018. 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.
Eligibility
Inclusion Criteria6
- years old, Male/Female, East Asian population
- 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 Criteria16
- Underwent gastrointestinal surgery (gastric/duodenal surgery or bariatric surgery)
- 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
Interventions
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 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
Locations(1)
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NCT05015283