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临床试验/NCT00698178
NCT00698178已完成不适用

Waist Circumference Versus Body Mass Index to Predict Severity of Gastroesophageal Reflux Disease

Lotung Poh-Ai Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2008年6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
500
试验地点
1
主要终点
the degree fo erosive esophagitis according to Los-Angels classification

研究概览

简要总结

Gastroesophageal reflux disease (GERD) is a common and important disorder. Previous studies have demonstrated the association of obesity with GERD, and now obesity is regarded as a risk factor for GERD. Moreover, body mass index (BMI), an indicator of general obesity, correlates with severity of symptoms and degree of erosive esophagitis. Waist circumference, an indicator of abdominal obesity, has stronger correlation with intra-abdominal pressure and low-grade inflammatory state when compared with BMI. Nevertheless the association of waist circumference with severity of GERD has not been studied.

The primary aim of this study is to compare BMI with waist circumference for their independent association with severity of GERD. The secondary aim is to evaluate independent risk factors of severity of GERD.

详细描述

This is a cross-section observational study. Outpatients presenting with acid reflux or heart burn are interviewed with standardized questionnaire to quantify severity of symptoms. The eligible patients undergo upper endoscopy to diagnose erosive esophagitis and further classify the degree of erosions according to Los-Angels classification. Enrolled patients receive anthropometric measurements to record body weight, body height and waist circumference on the day of enrollment.

Two outcomes are studied: the severity of GERD symptoms and the Los-Angels Classification of erosive esophagitis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age more than 20 years old and less than 70 years old
  • typical gastroesophageal reflux symptoms (heart burn and acid reflux)
  • outpatient
  • complete upper gastrointestinal endoscopy

排除标准

  • age less than 20 years or more than 70 years old
  • receive medication for reflux disease (including proton pump inhibitor, histamine type 2 receptor blocker, prokinetic agents) in previous one month
  • pregnant women
  • history of abdominal surgery
  • severe comorbidity with cirrhosis, end-stage renal disease, heart failure
  • no written informed consent

结局指标

主要结局

the degree fo erosive esophagitis according to Los-Angels classification

时间窗: on the day of endoscopy examination

次要结局

  • gastro-reflux severity score as evaluated by standardized questionnaire(at enrollment (before upper GI endoscopy))

研究者

发起方
Lotung Poh-Ai Hospital
申办方类型
Other

研究点 (1)

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