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临床试验/NCT02776982
NCT02776982已完成不适用

Influence of Central Obesity on the Esophageal Epithelial Barrier

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2016年11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
Mayo Clinic
入组人数
38
试验地点
2
主要终点
Compare intercellular space dilation as a marker for apical junction complex integrity in esophageal squamous epithelium by using transmission electron microscopy in those patients with/without gastroesophageal reflux and with/without central obesity.

研究概览

简要总结

This study is being done to help understand why some people with an increased amount of central obesity, without gastroesophageal reflux, develop changes to the lining of their esophagus that can potentially lead to esophageal adenocarcinoma (cancer).

研究设计

研究类型
Interventional
分配方式
Na
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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants who are undergoing clinically indicated upper endoscopy with Bravo ambulatory pH capsule (off reflux medications for 7 days), in the Esophageal Clinic at Mayo Clinic.

排除标准

  • Pre-existing or suspected Barrett's Esophagus (> 1cm of columnar mucosa in esophagus on endoscopy
  • Oral anticoagulation precluding endoscopic biopsies
  • Patients with known hypersensitivity to fluorescein sodium.

结局指标

主要结局

Compare intercellular space dilation as a marker for apical junction complex integrity in esophageal squamous epithelium by using transmission electron microscopy in those patients with/without gastroesophageal reflux and with/without central obesity.

时间窗: One year

次要结局

  • Compare the prostaglandin E2 level as measured by enzyme immunoassay in esophageal squamous epithelium in those patients with/without gastroesophageal reflux and with/without central obesity.(One year)
  • Compare paracellular permeability of esophageal squamous epithelium by measuring mucosal impedance and IV fluorescein leak using a confocal laser endomicroscope in those patients with/without gastroesophageal reflux and with/without central obesity.(One year)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prasad G. Iyer

MD

Mayo Clinic

研究点 (2)

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