Efficacy and Safety of One-anastomosis Versus Roux-en-Y Gastric Bypass for Type 2 Diabetes Remission

Official title

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

Overview

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.

Interventions

• 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
• 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

Primary outcome measures

• One year after operation, the complete remission rate of type 2 diabetes mellitus [HbA1c < 6%, fasting plasma glucose < 5.6 mmol/L, no need to use any hypoglycemic drugs] [Time frame: 1 year after surgery]

Secondary outcome measures (12)

• The remission rate of type 2 diabetes mellitus [Time frame: 5 years after surgery]
• The change of HbA1c [Time frame: 5 years after surgery]
• HbA1c value [Time frame: 5 years after surgery]
• The change of fasting blood glucose [Time frame: 5 years after surgery]
• Fasting blood glucose level [Time frame: 5 years after surgery]
• Fasting plasma insulin [Time frame: 5 years after surgery]
• Diabetes medication [Time frame: 5 years after surgery]
• Fasting blood lipids [Time frame: 5 years after surgery]
• Changes of arterial blood pressure (SBP, DBP) [Time frame: 5 years after surgery]
• The excess weight loss (%EWL) and the total weight loss (%TWL) after surgery. [Time frame: 5 years after surgery]
• Change waist circumference (cm) according to absolute waist circumference [Time frame: 5 years after surgery]
• Incidence of medical and surgical complications [Time frame: 5 years after surgery]

Eligibility criteria

Inclusion criteria

• 21-65 years old, Male/Female, East Asian population
• 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

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Friendship Hospital — Beijing

Publications

• 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. PMID 36175102

Identifiers

NCT: NCT05015283 · BFH-ORDER

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗