Gastric Emptying Measured With MRI and Scintigraphy in Patients With Successful Versus Unsuccessful Weight Loss After Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Gastric emptying compared between patients with poor and successful weight loss
研究概览
简要总结
Sleeve gastrectomy (SG) increases gastrointestinal motility, which influences feelings of fullness and satiety. By understanding the differences in gastric emptying (GE) between patients with sufficient weight loss (Total weight loss [TWL] > 35%) and insufficient weight loss (TWL < 25%), better insight in the aetiology of weight loss after sleeve gastrectomy may be obtained. GE will be measured with scintigraphy and MRI.
详细描述
Sleeve gastrectomy (SG) increases gastrointestinal motility, which influences feelings of fullness and satiety. Patients' weight loss response on SG varies widely and is difficult to predict. By understanding the differences in gastric emptying (GE) between patients with sufficient weight loss (Total weight loss [TWL] > 35%) and insufficient weight loss (TWL < 25%), better insight in the aetiology of weight loss after sleeve gastrectomy may be obtained. GE will be measured with scintigraphy and MRI. MRI is a non-invasive imaging method which provides more detailed images of the SG compared to the conventionally used scintigraphy scans.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with either TWL < 25% or TWL > 35%.
- •Patients who had a follow-up period of 2-3 years after sleeve gastrectomy
排除标准
- •Maximum BMI >50 kg/m2
- •Patients with a disease known to affect appetite, gastric emptying or gastrointestinal motility
- •Patients who are unable to stop medications that affect gastric emptying and/or motility prior to measurements. It is depending on t1/2 for how long they need to stop medication
- •Patients who started menopause
- •Patients with gastrointestinal problems or, gastric or intestinal diseases
- •Patients with a drug or alcohol addiction
- •Patients who are unable to stop smoking for 24h
- •Patients who are pregnant or lactating
- •Patients who have an intolerance or allergy for one of the components of the test product
- •Patients who have a contra-indication to MRI scanning
结局指标
主要结局
Gastric emptying compared between patients with poor and successful weight loss
时间窗: 2-3 years
Gastric emptying (T1/2 \[min\] and retention \[%/min\])
Gastric emptying compared between measured with MRI and scintigraphy
时间窗: 2-3 years
Gastric emptying (T1/2 \[min\] and retention \[%/min\])
次要结局
- to compare subjective ratings of gastric fullness and wellbeing between patients with successful and unsuccessful weight loss(2-3 years)
- to assess the association between gastric emptying rate and gastric sleeve characteristics in each group(2-3 years)
- Sleeve characteristics compared between patients with successful and unsuccessful (poor) weight loss(2-3 years)