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

Mengyi Li, Yang Liu, Wei Jei Lee, Scott A. Shikora, Maud Robert, Weu Wang, Simon Kin Hung Wong, Yuanyuan Kong, Daniel King Hung Tong, Chun Hai Tan, Na Zeng, Shaihong Zhu, Cunchuan Wang, Pin Zhang, Yan Gu, Rixing Bai, Fanqiang Meng, Zhongqi Mao, Xiangwen Zhao, Liangping WuYanjun Liu, Songhai Zhang, Peng Zhang, Zhongtao Zhang

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction Previous studies have demonstrated that one anastomosis gastric bypass (OAGB) is not inferior to Roux-en-Y gastric bypass (RYGB) in treating obesity. However, high level evidence comparing the efficacy and safety of both procedures in type 2 diabetes (T2D) treatment is still lacking, which is another main aim of bariatric surgery. The presented trial has been designed to aim at investigating the superiority of OAGB over the reference procedure RYGB in treating T2D as primary endpoint. And diabetes-related microvascular and macrovascular complications, cardiovascular comorbidities, weight loss, postoperative nutritional status, quality of life and overall complications will be followed up for 5 years as secondary endpoints. Methods and analysis This prospective, multicentre, randomised superiority open-label trial will be conducted in patients of Asian descent. A total of 248 patients (BMI?27.5 kg/m 2) who are diagnosed with T2D will be randomly assigned (1:1) to OAGB or RYGB with blocks of four. The primary endpoint is the complete diabetes remission rate defined as HbA1c?6.0% and fasting plasma glucose?5.6 mmol/L without any antidiabetic medications at 1 year after surgery. All secondary endpoints will be measured at different follow-up visit points, which will start at least 3 months after enrolment, with a continuous annual follow-up for five postoperative years in order to provide solid evidence on the efficacy and safety of OAGB in patients with T2D. Ethics and dissemination The study has been approved by the ethics committee of leading centre (Beijing Friendship Hospital, Capital Medical University, no. 2021-P2-037-03). The results generated from this work will be disseminated to academic audiences and the public via publications in international peer-reviewed journals and conferences. The data presented will be imported into a national data registry. Findings are expected to be available in 2025, which will facilitate clinical decision-making in the field. Trial registration number NCT05015283.

Original languageEnglish
Article numbere062206
JournalBMJ Open
Volume12
Issue number9
DOIs
Publication statusPublished - Sep 29 2022

Keywords

  • Clinical trials
  • DIABETES & ENDOCRINOLOGY
  • SURGERY

ASJC Scopus subject areas

  • Medicine(all)

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