Comparing two types of gastric bypass for treating type 2 diabetes
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
This study is testing which type of gastric bypass surgery, one-anastomosis or Roux-en-Y, works better for helping people with obesity and type 2 diabetes lose weight and improve their diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 248 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Beijing Friendship Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05015283 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the efficacy and safety of one-anastomosis gastric bypass (OAGB) versus Roux-en-Y gastric bypass (RYGB) in patients with type 2 diabetes mellitus (T2DM) who are also dealing with obesity. The study will involve participants aged 21-65 with a BMI between 27.5 and 50 kg/m2, who have been diagnosed with T2DM for at least six months and are currently on diabetes medications. The primary focus will be on weight loss and the effectiveness of these two surgical methods in achieving diabetes remission. The trial is being conducted at Beijing Friendship Hospital and involves collaboration with several other hospitals in China.
Who should consider this trial
Good fit: Ideal candidates are East Asian adults aged 21-65 with obesity and type 2 diabetes who meet specific BMI and diabetes duration criteria.
Not a fit: Patients with a history of gastrointestinal surgery, serious cardiovascular diseases, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective surgical options for achieving diabetes remission in obese patients.
How similar studies have performed: Previous studies have shown promising results for both surgical methods, but this direct comparison is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- Beijing Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Zhongtao Zhang, M.D.;Ph.D — Beijing Friendship Hospital
- Study coordinator: Zhongtao Zhang, M.D.;Ph.D
- Email: zhangzht@ccmu.edu.cn
- Phone: +86-13801060364
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.