TY - JOUR
T1 - Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for type 2 diabetes remission (ORDER)
T2 - protocol of a multicentre, randomised controlled, open-label, superiority trial
AU - Li, Mengyi
AU - Liu, Yang
AU - Lee, Wei Jei
AU - Shikora, Scott A.
AU - Robert, Maud
AU - Wang, Weu
AU - Wong, Simon Kin Hung
AU - Kong, Yuanyuan
AU - Tong, Daniel King Hung
AU - Tan, Chun Hai
AU - Zeng, Na
AU - Zhu, Shaihong
AU - Wang, Cunchuan
AU - Zhang, Pin
AU - Gu, Yan
AU - Bai, Rixing
AU - Meng, Fanqiang
AU - Mao, Zhongqi
AU - Zhao, Xiangwen
AU - Wu, Liangping
AU - Liu, Yanjun
AU - Zhang, Songhai
AU - Zhang, Peng
AU - Zhang, Zhongtao
N1 - Funding Information:
This work is supported by Beijing Municipal Science & Technology Commission (Z211100002921029), National Key Technologies R&D Programme (2015BAI13B09), Beithune Charitable Foundation (DXWKYJ001) and Beijing Excellent Talents Training Funding Programme (2018000021469G195). The funding sources have not involved in this study design and will not have any role during the study execution, analyses and interpretation of the data, writing manuscripts or decision to submit for publication.
Publisher Copyright:
© 2022 BMJ Publishing Group. All rights reserved.
PY - 2022/9/29
Y1 - 2022/9/29
N2 - 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.
AB - 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.
KW - Clinical trials
KW - DIABETES & ENDOCRINOLOGY
KW - SURGERY
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U2 - 10.1136/bmjopen-2022-062206
DO - 10.1136/bmjopen-2022-062206
M3 - Article
C2 - 36175102
AN - SCOPUS:85138937325
SN - 2044-6055
VL - 12
JO - BMJ Open
JF - BMJ Open
IS - 9
M1 - e062206
ER -