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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    248
  • sponsor
    Beijing Friendship Hospital
Updated on 7 March 2022

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.

Details
Condition Type2 Diabetes, Complication of Bariatric Procedure
Treatment The laparoscopic One-anastomosis gastric bypass will consist of:, The laparoscopic Roux-en-Y gastric bypass will consist of:
Clinical Study IdentifierNCT05015283
SponsorBeijing Friendship Hospital
Last Modified on7 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

-65 years old, Male/Female, East Asian population
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
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