Actively Recruiting
Efficacy and Safety of One-anastomosis Versus Roux-en-Y Gastric Bypass for Type 2 Diabetes Remission
Led by Beijing Friendship Hospital · Updated on 2022-08-03
248
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
Sponsors
B
Beijing Friendship Hospital
Lead Sponsor
B
Beijing Tiantan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of One-anastomosis Versus Roux-en-Y Gastric Bypass for Type 2 Diabetes Remission
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 21 and 65 years, male or female, East Asian population
- Body mass index (BMI) between 27.5 and 50 kg/m2
- Diagnosis of type 2 diabetes for at least 6 months
- HbA1c level of 7.0% or higher
- Currently using one or more oral or injectable diabetes medications, including insulin or glucagon-like peptide-1 receptor agonists
- Recommended for either OAGB or RYGB surgery by a multidisciplinary team
You will not qualify if you...
- Previous gastrointestinal surgery including gastric, duodenal, or bariatric surgery
- Fasting C-peptide level less than half the normal minimum
- Presence of active gastrointestinal ulcers
- Infection with Helicobacter pylori
- History of serious cardiovascular or cerebrovascular diseases such as myocardial infarction or stroke
- History of cirrhosis with Child-Pugh class A or higher
- Chronic kidney disease with eGFR below 60 ml/min/1.73 m2
- Presence of inflammatory bowel diseases such as ulcerative colitis or Crohn's disease
- Chronic anemia with hemoglobin below 100 g/L for males or below 90 g/L for females
- Planning to conceive during the study period
- Uncontrolled mental or psychological disorders
- Expected survival less than 5 years due to end-stage disease or past/current cancer
- Participation in other clinical studies that conflict with this study
- Unable to understand or unwilling to sign informed consent
- Presence of gallstones requiring cholecystectomy
- Reflux esophagitis above grade A
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Friendship Hospital
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
Research Team
Z
Zhongtao Zhang, M.D.;Ph.D
CONTACT
M
Mengyi Li, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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