Impact of an Increased Restrictive Factor of One Anastomosis Gastric Bypass Using a "FundoRing" Fundoplication on Metabolic Outcomes in Type 2 Diabetes Mellitus: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Metabolic improvements of type 2 diabetes
研究概览
简要总结
The purpose of the study is to evaluate the effect of an increased restrictive factor of one gastric anastomosis (OAGB) using a "FundoRing" fundoplication on metabolic outcomes in type 2 diabetes mellitus. The randomized controlled trial compared two interventional procedures: one group - using the original fundoplication procedure to enhance the restrictive effect and another group without fundoplication in the standard version of the OAGB.
详细描述
The randomized controlled trial compared two interventional procedures: one group - using the original fundoplication procedure to enhance the restrictive effect and another group without fundoplication in the standard version of the OAGB.
The purpose of the study is to evaluate the effect of an increased restrictive factor of one gastric anastomosis (OAGB) using a "FundoRing" fundoplication on metabolic outcomes in type 2 diabetes mellitus.
The main hypothesis is that an increase in the restrictive effect will lead to an increase in the metabolic effect and an increase in its persistence over time.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 25-55 kg/m2
- •Patients with Diabetes Mellitus, Type 2
排除标准
- •BMI <25 and >55 kg/m2
- •Patients without Diabetes Mellitus, Type 2
- •History of surgery on the stomach
- •Less than 18 or more than 60 years of age
- •Psychiatric illness
- •Patients unwilling or unable to provide informed consent
结局指标
主要结局
Metabolic improvements of type 2 diabetes
时间窗: Baseline, at 12, 24, 36 months after surgery
Change % of Glycosylated Hemoglobin. A1C level is below 5.7% - full remisson, a level of 5.7% to 6.4% indicates partial remission , and a level of 6.5% or more indicates diabetes
次要结局
- Change of body mass index(Baseline, at 12, 24, 36 months after surgery)