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 Wu, Yanjun Liu, Songhai Zhang, Peng Zhang, Zhongtao Zhang, CarMeN, laboratoire, Capital University of Medical Sciences [Beijing] (CUMS), Min-Sheng General Hospital [Taiwan, China] (MSGH), Brigham and Women’s Hospital [Boston, MA], Harvard Medical School [Boston] (HMS), Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Hôpital Edouard Herriot [CHU - HCL], Hospices Civils de Lyon (HCL), Taipei Medical University, Prince of Wales Hospital, Hong Kong Sanatorium and Hospital [Hong Kong] (HKSH), Surgicare Bariatric and General Surgery Clinic [Singapore] (SBGSC), Peking University [Beijing], The Third Xiangya Hospital of Central South University [Hunan, China] (2TXH), The First Affiliated Hospital of Jinan University [Guangzhou, China] (TFAH), Shanghai Jiao Tong University [Shanghai], Fudan University [Shanghai], China-Japan Friendship hospital, Soochow University, Zhongshan Xiaolan People's Hospital [Guangdong, China] (ZXPH), Guangzhou University of Chinese Medicine, Southwest Jiaotong University (SWJTU), Chengdu Third People's Hospital [Sichuan, China] (CTPH), and Henan University of Science and Technology
IntroductionPrevious 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 analysisThis prospective, multicentre, randomised superiority open-label trial will be conducted in patients of Asian descent. A total of 248 patients (BMI≥27.5 kg/m2) 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 disseminationThe 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 numberNCT05015283.