NCT02688920已完成不适用
A Single-center, Observational, Intraluminal Imaging Study of Duodenal Layer Morphometry in Patients With and Without Type 2 Diabetes Undergoing Endoscopy of the Upper Gastrointestinal Tract
Victoria Gomez1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2016年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Thickness of the duodenal mucosa using OCT, and EUS if possible
研究概览
简要总结
This observational study is conducted to determine how the duodenal layer thicknesses (mucosa, submucosa, and muscularis) vary with several factors in patients with and without type 2 diabetes.
详细描述
Study Objectives
- To assess duodenal layer (mucosa, submucosa and muscularis) thickness differences between patients with and without type 2 diabetes using endoscopic ultrasound (EUS) and optical coherence tomography (OCT).
- To assess duodenal layer thickness differences between patients with type 2 diabetes.
- To assess duodenal layer thickness differences as a function of measurement location along the length of the duodenum.
- To compare measurements obtained by endoscopic ultrasound, to those obtained by optical coherence tomography.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient is already scheduled for upper endoscopy with ultrasound or OCT, such as those with Barrett's esophagus.
- •Patient is willing to sign an informed consent form.
排除标准
- •Patient is not a candidate for endoscopy, EUS, or OCT, such as those with strictures, inflammatory disease or previous anastomosis of the esophagus or duodenum.
结局指标
主要结局
Thickness of the duodenal mucosa using OCT, and EUS if possible
时间窗: During imaging
次要结局
- Thickness of the duodenal submucosa using OCT if possible, and EUS(During imaging)
研究者
Victoria Gomez
Gastroenterologist
Mayo Clinic
研究点 (1)
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