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

• ClinicalTrials.gov Identifier: NCT05015283
• Recruitment Status: Recruiting
• First Posted: August 20, 2021
• Last Update Posted: August 3, 2022
• Sponsor: Beijing Friendship Hospital
• Collaborators: Beijing Tiantan Hospital; Shanghai Jiao Tong University Affiliated Sixth People's Hospital; Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; The Third Xiangya Hospital of Central South University; The First Affiliated Hospital of Soochow University; The Third People's Hospital of Chengdu; Taipei Medical University Hospital
• Information provided by (Responsible Party): Zhongtao Zhang, Beijing Friendship Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Type2 Diabetes; Complication of Bariatric Procedure	Procedure: The laparoscopic One-anastomosis gastric bypass will consist of: Procedure: The laparoscopic Roux-en-Y gastric bypass will consist of:	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 248 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: February 1, 2022
• Estimated Primary Completion Date: October 1, 2026
• Estimated Study Completion Date: December 31, 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: Laparoscopic One-anastomosis gastric bypass; In this group, the bariatric procedure is laparoscopic one-anastomosis gastric bypass, all operations follow the same standard operating procedure.	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
Active Comparator: Laparoscopic Roux-en-Y gastric bypass; In this group, the bariatric procedure is laparoscopic Roux-en-Y gastric bypass, all operations follow the same standard operating procedure.	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

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   Complete remission of type 2 diabetes mellitus: the blood sugar HbA1c<6.0% and fasting plasma glucose< 5.6 mmol/L can be controlled only by changing lifestyle intervention without taking hypoglycemic agents after operation. Partial remission: blood glucose can be controlled only by changing lifestyle intervention after operation. HbA1c<6.5%, fasting plasma glucose 5.6~6.9mmol/L, and blood glucose 7.8~11.0mmol/L 2 hours after meal. Failure: blood sugar was relieved once, and then returned to the preoperative level.Unified OGTT measurement method

Secondary Outcome Measures :

1. The remission rate of type 2 diabetes mellitus [ Time Frame: 5 years after surgery ]
   [HbA1c < 6%, with or without hypoglycemic drugs] Visit 1: Baseline Visit (Day 0-1) Visit 2:Post-op 1 month (+7 Days) Visit 3: Post-op 3 months(+7 Days) Visit 4: Post-op 6 months(14 Days) Visit 5: Post-op 12 months (+30 Days) Visit 6：Post-op 24 months (±30 Days) Visit 7:Post-op 36 months (±30 Days) Visit 8：Post-op 60 months (±30 Days)
2. The change of HbA1c [ Time Frame: 5 years after surgery ]
   Changes of glycosylated hemoglobin (HbA1c) compared with baseline.Visit 1: Baseline Visit (Day 0-1) Visit 2:Post-op 1 month (+7 Days) Visit 3: Post-op 3 months(+7 Days) Visit 4: Post-op 6 months(14 Days) Visit 5: Post-op 12 months (+30 Days) Visit 6：Post-op 24 months (±30 Days) Visit 7:Post-op 36 months (±30 Days) Visit 8：Post-op 60 months (±30 Days)
3. HbA1c value [ Time Frame: 5 years after surgery ]
   The value of HbA1c.Visit 1: Baseline Visit (Day 0-1) Visit 2:Post-op 1 month (+7 Days) Visit 3: Post-op 3 months(+7 Days) Visit 4: Post-op 6 months(14 Days) Visit 5: Post-op 12 months (+30 Days) Visit 6：Post-op 24 months (±30 Days) Visit 7:Post-op 36 months (±30 Days) Visit 8：Post-op 60 months (±30 Days)
4. The change of fasting blood glucose [ Time Frame: 5 years after surgery ]
   Changes of fasting blood glucose compared with baseline.Visit 1: Baseline Visit (Day 0-1) Visit 2:Post-op 1 month (+7 Days) Visit 3: Post-op 3 months(+7 Days) Visit 4: Post-op 6 months(14 Days) Visit 5: Post-op 12 months (+30 Days) Visit 6：Post-op 24 months (±30 Days) Visit 7:Post-op 36 months (±30 Days) Visit 8：Post-op 60 months (±30 Days)
5. Fasting blood glucose level [ Time Frame: 5 years after surgery ]
   The fasting blood glucose level.Visit 1: Baseline Visit (Day 0-1) Visit 2:Post-op 1 month (+7 Days) Visit 3: Post-op 3 months(+7 Days) Visit 4: Post-op 6 months(14 Days) Visit 5: Post-op 12 months (+30 Days) Visit 6：Post-op 24 months (±30 Days) Visit 7:Post-op 36 months (±30 Days) Visit 8：Post-op 60 months (±30 Days)
6. Fasting plasma insulin [ Time Frame: 5 years after surgery ]
   The value of fasting plasma insulin.Visit 1: Baseline Visit (Day 0-1) Visit 2:Post-op 1 month (+7 Days) Visit 3: Post-op 3 months(+7 Days) Visit 4: Post-op 6 months(14 Days) Visit 5: Post-op 12 months (+30 Days) Visit 6：Post-op 24 months (±30 Days) Visit 7:Post-op 36 months (±30 Days) Visit 8：Post-op 60 months (±30 Days)
7. Diabetes medication [ Time Frame: 5 years after surgery ]
   Follow up was used to observe whether the dosage of postoperative diabetes was reduced.Visit 1: Baseline Visit (Day 0-1) Visit 2:Post-op 1 month (+7 Days) Visit 3: Post-op 3 months(+7 Days) Visit 4: Post-op 6 months(14 Days) Visit 5: Post-op 12 months (+30 Days) Visit 6：Post-op 24 months (±30 Days) Visit 7:Post-op 36 months (±30 Days) Visit 8：Post-op 60 months (±30 Days)
8. Fasting blood lipids [ Time Frame: 5 years after surgery ]
   The value of fasting blood lipids.Visit 1: Baseline Visit (Day 0-1) Visit 2:Post-op 1 month (+7 Days) Visit 3: Post-op 3 months(+7 Days) Visit 4: Post-op 6 months(14 Days) Visit 5: Post-op 12 months (+30 Days) Visit 6：Post-op 24 months (±30 Days) Visit 7:Post-op 36 months (±30 Days) Visit 8：Post-op 60 months (±30 Days)
9. Changes of arterial blood pressure (SBP, DBP) [ Time Frame: 5 years after surgery ]
   The change of arterial blood pressure (SBP, DBP).Visit 1: Baseline Visit (Day 0-1) Visit 2:Post-op 1 month (+7 Days) Visit 3: Post-op 3 months(+7 Days) Visit 4: Post-op 6 months(14 Days) Visit 5: Post-op 12 months (+30 Days) Visit 6：Post-op 24 months (±30 Days) Visit 7:Post-op 36 months (±30 Days) Visit 8：Post-op 60 months (±30 Days)
10. The excess weight loss (%EWL) and the total weight loss (%TWL) after surgery. [ Time Frame: 5 years after surgery ]
    %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2),%TWL=[(initial weight)-(post-op weight)]/initial weight.Visit 1: Baseline Visit (Day 0-1) Visit 2:Post-op 1 month (+7 Days) Visit 3: Post-op 3 months(+7 Days) Visit 4: Post-op 6 months(14 Days) Visit 5: Post-op 12 months (+30 Days) Visit 6：Post-op 24 months (±30 Days) Visit 7:Post-op 36 months (±30 Days) Visit 8：Post-op 60 months (±30 Days)
11. Change waist circumference (cm) according to absolute waist circumference [ Time Frame: 5 years after surgery ]
    Change waist circumference (cm) according to absolute waist circumference.Visit 1: Baseline Visit (Day 0-1) Visit 2:Post-op 1 month (+7 Days) Visit 3: Post-op 3 months(+7 Days) Visit 4: Post-op 6 months(14 Days) Visit 5: Post-op 12 months (+30 Days) Visit 6：Post-op 24 months (±30 Days) Visit 7:Post-op 36 months (±30 Days) Visit 8：Post-op 60 months (±30 Days)
12. Incidence of medical and surgical complications [ Time Frame: 5 years after surgery ]
    Incidence of medical and surgical complications (anastomotic leakage, bile reflux, intestinal obstruction, anastomotic ulcer, anastomotic stenosis, internal hernia, chronic gastritis, esophagitis, iron deficiency anemia ...) Visit 1:Post-op 1 month (+7 Days) Visit 2: Post-op 3 months(+7 Days) Visit 3: Post-op 6 months(14 Days) Visit 4: Post-op 12 months (+30 Days) Visit 5：Post-op 24 months (±30 Days) Visit 6:Post-op 36 months (±30 Days) Visit 7：Post-op 60 months (±30 Days)
13. Incidence of surgical complications [ Time Frame: 5 years after surgery ]
    According to the grade of surgical complications, proportion of surgical complications in the total number.Visit 1: Baseline Visit (Day 0-1) Visit 2:Post-op 1 month (+7 Days) Visit 3: Post-op 3 months(+7 Days) Visit 4: Post-op 6 months(14 Days) Visit 5: Post-op 12 months (+30 Days) Visit 6：Post-op 24 months (±30 Days) Visit 7:Post-op 36 months (±30 Days) Visit 8：Post-op 60 months (±30 Days)
14. Surgery time [ Time Frame: Surgery day (day 0) record ]
    Surgery time.Visit 1: Surgery day (day 0) record
15. Average length of stay, based on the length of stay from operation (surgery day =day0) to the end of hospitalization [ Time Frame: 30 days after surgery ]
    Average length of stay, based on the length of stay from operation (surgery day =day0) to the end of hospitalization.Visit 1: Surgery day (day 0) record
16. Postoperative quality of life of patients, according to Impact Weight Quality Of Life questionnaire for weight loss surgery, scores were obtained [ Time Frame: One day before surgery,5 years after surgery ]
    According to Impact Weight Quality Of Life questionnaire for weight loss surgery, scores were obtained.The higher the score, the better the quality of life. Visit 1: Baseline Visit (Day 0-1) Visit 2:Post-op 1 month (+7 Days) Visit 3: Post-op 3 months(+7 Days) Visit 4: Post-op 6 months(14 Days) Visit 5: Post-op 12 months (+30 Days) Visit 6：Post-op 24 months (±30 Days) Visit 7:Post-op 36 months (±30 Days) Visit 8：Post-op 60 months (±30 Days)
17. Postoperative gastroesophageal reflux [ Time Frame: One day before surgery,5 years after surgery ]
    Evaluate according to gastroesophageal reflux disease questionnaire. The higher the score, the more likely there is gastroesophageal reflux. Visit 1: Baseline Visit (Day 0-1) Visit 2:Post-op 1 month (+7 Days) Visit 3: Post-op 3 months(+7 Days) Visit 4: Post-op 6 months(14 Days) Visit 5: Post-op 12 months (+30 Days) Visit 6：Post-op 24 months (±30 Days) Visit 7:Post-op 36 months (±30 Days) Visit 8：Post-op 60 months (±30 Days)
18. Diarrhea frequency [ Time Frame: One day before surgery,5 years after surgery ]
    Based on gastrointestinal symptom rating scale.Visit 1: Baseline Visit (Day 0-1) Visit 2:Post-op 1 month (+7 Days) Visit 3: Post-op 3 months(+7 Days) Visit 4: Post-op 6 months(14 Days) Visit 5: Post-op 12 months (+30 Days) Visit 6：Post-op 24 months (±30 Days) Visit 7:Post-op 36 months (±30 Days) Visit 8：Post-op 60 months (±30 Days)
19. Dumping syndrome and hypoglycemia symptoms [ Time Frame: 5 years after surgery ]
    Dumping syndrome and hypoglycemia symptoms.Dumping syndrome and hypoglycemia symptoms will be evaluated by questionnaire.Visit 1: Baseline Visit (Day 0-1) Visit 2:Post-op 1 month (+7 Days) Visit 3: Post-op 3 months(+7 Days) Visit 4: Post-op 6 months(14 Days) Visit 5: Post-op 12 months (+30 Days) Visit 6：Post-op 24 months (±30 Days) Visit 7:Post-op 36 months (±30 Days) Visit 8：Post-op 60 months (±30 Days)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Zhongtao Zhang, M.D.;Ph.D; +86-13801060364; zhangzht@ccmu.edu.cn

Contact: Mengyi Li, M.D; +86-15810993198; limengyi@ccmu.edu.cn

Locations

China, Beijing

Beijing Friendship Hospital; Recruiting

Beijing, Beijing, China, 100050

Contact: Zhongtao Zhang, M.D.;Ph.D +86-13801060364 zhangzht@ccmu.edu.cn

Principal Investigator: Zhongtao Zhang, M.D.;Ph.D

Sponsors and Collaborators

Beijing Friendship Hospital

Beijing Tiantan Hospital

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

The Third Xiangya Hospital of Central South University

The First Affiliated Hospital of Soochow University

The Third People's Hospital of Chengdu

Taipei Medical University Hospital

Investigators

• Principal Investigator: Zhongtao Zhang, M.D.;Ph.D; Beijing Friendship Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. BMJ Open. 2022 Sep 29;12(9):e062206. doi: 10.1136/bmjopen-2022-062206.

• Responsible Party: Zhongtao Zhang, Director of general surgery, principal investigator, Beijing Friendship Hospital
• ClinicalTrials.gov Identifier: NCT05015283
• Other Study ID Numbers: BFH-ORDER
• First Posted: August 20, 2021
• Last Update Posted: August 3, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Plan Description

1. Will individual deidentified participant data (including data dictionaries) will be shared: Yes
2. what data in particular will be shared: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
3. what other documents will be available: study portocol
4. when will data be availuble (start and end dates): Beginning 6 months and ending 24 months following article publicaiton.
5. With whom: Investigators whose proposed use of the data has been approved by an independent review commmittee identified for this purepose.
6. For what types of analysis: For individual participant data meta-analysis.
7. By what mmechanism will data be made available: Proposals should be directed to zhangzht@ccmu.edu.cn to gain access, data requestors will need to sign a data access agreement.

• Supporting Materials: Study Protocol
• Time Frame: Beginning 6 months and ending 24 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhongtao Zhang, Beijing Friendship Hospital:

Bariatric surgery

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases