Comparing two types of gastric bypass for treating type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.