Clinical trial NCT05015283: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type2 Diabetes
Complication of Bariatric Procedure
Keywords: Bariatric surgery
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: The Third Xiangya Hospital of Central South University
name: The First Affiliated Hospital of Soochow University
name: The Third People's Hospital of Chengdu
name: Taipei Medical University Hospital
First posted: 2021-08-20
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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]
timeFrame: 1 year after surgery
Secondary outcomes:
measure: The remission rate of type 2 diabetes mellitus
timeFrame: 5 years after surgery
measure: The change of HbA1c
timeFrame: 5 years after surgery
measure: HbA1c value
timeFrame: 5 years after surgery
measure: The change of fasting blood glucose
timeFrame: 5 years after surgery
measure: Fasting blood glucose level
timeFrame: 5 years after surgery
measure: Fasting plasma insulin
timeFrame: 5 years after surgery
measure: Diabetes medication
timeFrame: 5 years after surgery
measure: Fasting blood lipids
timeFrame: 5 years after surgery
measure: Changes of arterial blood pressure (SBP, DBP)
timeFrame: 5 years after surgery
measure: The excess weight loss (%EWL) and the total weight loss (%TWL) after surgery.
timeFrame: 5 years after surgery
measure: Change waist circumference (cm) according to absolute waist circumference
timeFrame: 5 years after surgery
measure: Incidence of medical and surgical complications
timeFrame: 5 years after surgery
measure: Incidence of surgical complications
timeFrame: 5 years after surgery
measure: Surgery time
timeFrame: Surgery day (day 0) record
measure: Average length of stay, based on the length of stay from operation (surgery day =day0) to the end of hospitalization
timeFrame: 30 days after surgery
measure: Postoperative quality of life of patients, according to Impact Weight Quality Of Life questionnaire for weight loss surgery, scores were obtained
timeFrame: One day before surgery,5 years after surgery
measure: Postoperative gastroesophageal reflux
timeFrame: One day before surgery,5 years after surgery
measure: Diarrhea frequency
timeFrame: One day before surgery,5 years after surgery
measure: Dumping syndrome and hypoglycemia symptoms
timeFrame: 5 years after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Zhongtao Zhang, M.D.;Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.