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

Launched by BEIJING FRIENDSHIP HOSPITAL · Aug 15, 2021

Keywords

ClinConnect Summary

This clinical trial is comparing two types of weight loss surgeries—One-anastomosis gastric bypass (OAGB) and Roux-en-Y gastric bypass (RYGB)—to see which is more effective in helping people with type 2 diabetes (T2DM) improve their blood sugar levels. Both surgeries aim to help patients lose weight and manage diabetes more effectively. The study will involve 248 patients aged 21 to 65, who are overweight and have been diagnosed with T2DM for at least six months. To participate, individuals must be currently using diabetes medications and meet specific health criteria.

Participants in the trial can expect to be randomly assigned to one of the two surgical procedures and will be monitored for five years to assess their blood sugar levels and overall health. This research is important because it aims to provide clearer evidence about the benefits and risks of these two surgical options for treating diabetes in obese patients. If you or someone you know is struggling with diabetes and weight issues, this trial could be a valuable opportunity to explore surgical options that may lead to better health outcomes.

Gender

ALL

Eligibility 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