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

Capital Medical University

Status: Enrolling

Conditions: Complication of Bariatric Procedure; Type2 Diabetes

Treatments: Procedure: The laparoscopic Roux-en-Y gastric bypass will consist of:; Procedure: The laparoscopic One-anastomosis gastric bypass will consist of:

Study type: Interventional

Funder types: Other

Identifiers

NCT05015283

BFH-ORDER

Details and patient eligibility

About

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.

Enrollment: 248 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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248 participants in 2 patient groups

Laparoscopic One-anastomosis gastric bypass

Experimental group

Description:

In this group, the bariatric procedure is laparoscopic one-anastomosis gastric bypass, all operations follow the same standard operating procedure.

Treatment:

Procedure: The laparoscopic One-anastomosis gastric bypass will consist of:

Laparoscopic Roux-en-Y gastric bypass

Active Comparator group

Description:

In this group, the bariatric procedure is laparoscopic Roux-en-Y gastric bypass, all operations follow the same standard operating procedure.

Treatment:

Procedure: The laparoscopic Roux-en-Y gastric bypass will consist of: