NCT00275743已完成1 期
Dynamic MRI - A Novel Approach for Measuring Gastric Accommodation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Gastric Volume (fasting and postprandial)
研究概览
简要总结
This study is being done to test new way of measuring the relaxation of the stomach after a meal (called gastric accommodation) by using a MRI scan. This new test will be compared with the standard test of measuring stomach relaxation that uses radioactive tracers. These tests will be compared in healthy volunteers and people with upper abdominal symptoms (known as dyspepsia).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •for Dyspeptic patients (30 required)
- •One or more of eight postprandial dyspeptic symptoms i.e. fullness, bloating, epigastric discomfort, early satiety, nausea, vomiting, belching, pain for a minimum of 3 months, OR
- •Patients fulfilling the ROME-II criteria for functional dyspepsia,
- •AND no symptom improvement after standard dose PPI treatment,
- •AND normal upper gastrointestinal endoscopy within six months prior to the study
- •Inclusion Criteria for Healthy Controls (20 required)
- •Absence of current abdominal symptoms or depression
排除标准
- •for all Participants
- •Known structural upper GI disorder (e.g. peptic ulcer disease, esophagitis, malignancy);
- •Abdominal surgery other than appendectomy, cholecystectomy, hysterectomy, tubal ligation, or inguinal hernia repair;
- •Medications that may alter gastrointestinal motility, e.g., serotoninergic agents, alpha adrenergic agonists, calcium channel or beta blockers; stable dose of thyroxine will be permitted;
- •Pregnant or breast-feeding females;
- •Known claustrophobia;
- •Any metal objects in the body (e.g. metal implants, pacemaker, AICD)
结局指标
主要结局
Gastric Volume (fasting and postprandial)
Antral Contractility
次要结局
未报告次要终点
研究者
研究点 (1)
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