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

RecruitingNAAges 18 Years - 65 YearsAllBeijing Friendship Hospital
NCT05015283 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 second

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📋 Eligibility rules (as published)
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
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What it tests

  • The laparoscopic One-anastomosis gastric bypass will consist of:
  • The laparoscopic Roux-en-Y gastric bypass will consist of:
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Where

1 site
Beijing Friendship Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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