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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- One year after operation, the complete remission rate of type 2 diabetes mellitus [HbA1c < 6%, fasting plasma glucose < 5.6 mmol/L, no need to use any hypoglycemic drugs]
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
One year after operation, the complete remission rate of type 2 diabetes mellitus [HbA1c < 6%, fasting plasma glucose < 5.6 mmol/L, no need to use any hypoglycemic drugs]
时间窗: 1 year after surgery
Complete remission of type 2 diabetes mellitus: the blood sugar HbA1c\<6.0% and fasting plasma glucose\< 5.6 mmol/L can be controlled only by changing lifestyle intervention without taking hypoglycemic agents after operation. Partial remission: blood glucose can be controlled only by changing lifestyle intervention after operation. HbA1c\<6.5%, fasting plasma glucose 5.6\~6.9mmol/L, and blood glucose 7.8\~11.0mmol/L 2 hours after meal. Failure: blood sugar was relieved once, and then returned to the preoperative level.Unified OGTT measurement method
次要结局
- Diabetes medication(5 years after surgery)
- Change waist circumference (cm) according to absolute waist circumference(5 years after surgery)
- Average length of stay, based on the length of stay from operation (surgery day =day0) to the end of hospitalization(30 days after surgery)
- The change of HbA1c(5 years after surgery)
- HbA1c value(5 years after surgery)
- Surgery time(Surgery day (day 0) record)
- The remission rate of type 2 diabetes mellitus(5 years after surgery)
- Fasting blood glucose level(5 years after surgery)
- Postoperative gastroesophageal reflux(One day before surgery,5 years after surgery)
- Fasting plasma insulin(5 years after surgery)
- Dumping syndrome and hypoglycemia symptoms(5 years after surgery)
- Postoperative quality of life of patients, according to Impact Weight Quality Of Life questionnaire for weight loss surgery, scores were obtained(One day before surgery,5 years after surgery)
- The change of fasting blood glucose(5 years after surgery)
- Fasting blood lipids(5 years after surgery)
- Changes of arterial blood pressure (SBP, DBP)(5 years after surgery)
- The excess weight loss (%EWL) and the total weight loss (%TWL) after surgery.(5 years after surgery)
- Incidence of medical and surgical complications(5 years after surgery)
- Incidence of surgical complications(5 years after surgery)
- Diarrhea frequency(One day before surgery,5 years after surgery)
研究者
Zhongtao Zhang
Director of general surgery, principal investigator
Beijing Friendship Hospital