Gastric and Autonomic Functions in Patients With Intragastric Balloon
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Gastric slow waves
研究概览
简要总结
The study aims to measure the effect of intragastric balloon on gastric function, particularly gastric accommodation and pace making, and the possible underlying changes in autonomic function
详细描述
The intragastric balloon is a space-occupying device that is hypothesized to function by inducing early satiety. Additionally, insertion of an intragastric balloon causes delayed gastric emptying; longer gastric emptying times after balloon insertion are correlated with more weight loss. The exact mechanism of function, however, is not clear and likely multifactorial. The investigators hypothesize that the intragastric balloon causes weight loss by affecting gastric and autonomic function, including pace-making and accommodation, and that the difference in responsiveness among patients may be mediated by differences in gastric function.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
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
- •Patients scheduled to undergo intragastric balloon implantation
- •Ability to comply to study schedule.
排除标准
- •Unable to give informed consent
- •Currently taking prokinetic, anticholinergic or dopaminergic agents which could potentially modify gastric motility
- •Have a history of bariatric or gastrointestinal surgery
- •Pregnant or preparing to conceive a child.
结局指标
主要结局
Gastric slow waves
时间窗: 1 year
A noninvasive method similar to electrocardiography, called electrogastrography, will be used in this study to assess the effects of intragastric balloon on gastric slow waves
Gastric accommodation
时间窗: 1 year
A noninvasive nutrient drink test will be performed and accommodation will be assessed using a symptom (fullness, nausea, belching of air, cramps in the abdomen, bloating, and pain) scale 0 to 3 points with higher values indicating more and/or greater symptoms
Autonomic function
时间窗: 1 year
The ECG will be recorded simultaneously with the Electrogastrograph (EGG) and will be used to noninvasively assess the vagal and sympathetic activities as well as the sympathovagal ratio
次要结局
- Dyspepsia symptom severity index (DSSI) questionnaire(1 year)
- Gastroparesis cardinal symptom index (GCSI) questionnaire(1 year)
- Gastroesophageal reflux disease-health related quality of life (GERD-HRQL) questionnaire(1 year)
- SF-36 Questionnaire(1 year)