RecruitingNot ApplicableNCT05015283

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

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


Sponsor

Beijing Friendship Hospital

Enrollment

248 participants

Start Date

Feb 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study compares two types of weight loss surgery — one-anastomosis gastric bypass (OAGB) and Roux-en-Y gastric bypass (RYGB) — to see which is more effective and safer at putting type 2 diabetes into remission in East Asian patients with obesity. **You may be eligible if...** - You are between 21 and 65 years old - You are of East Asian background - Your BMI is between 27.5 and 50 kg/m² - You have had type 2 diabetes for at least 6 months - Your HbA1c (blood sugar control marker) is 7.0% or higher - You are currently taking oral or injectable diabetes medications (including insulin) - A multidisciplinary medical team has recommended you for this surgery **You may NOT be eligible if...** - You have had prior stomach or intestinal surgery or bariatric surgery - Your fasting c-peptide level is very low (suggesting insulin-producing cells have stopped working) - You have severe heart, kidney, or liver disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREThe 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

PROCEDUREThe 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


Locations(1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

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NCT05015283


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