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

NCT ID: NCT00698178

Last Updated: 2010-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastroesophageal Reflux Disease Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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NERD

patients with typical gastro-reflux symptoms but no erosions were discernible on upper gastrointestinal endoscopy

Anthropometric measurements

Intervention Type OTHER

All patients undergo anthropometric measurements to record body weight, body height and waist circumference on the day of enrollment

EE

Patients with both typical gastroesophageal reflux symptoms and characteristic flam-like erosions as demonstrated on upper gastrointestinal endoscopy

Anthropometric measurements

Intervention Type OTHER

All patients undergo anthropometric measurements to record body weight, body height and waist circumference on the day of enrollment

FD

Patients report no typical reflux symptoms but fulfill diagnostic criteria of functional dyspepsia, whose upper gastrointestinal endoscopy are negative.

Anthropometric measurements

Intervention Type OTHER

All patients undergo anthropometric measurements to record body weight, body height and waist circumference on the day of enrollment

Interventions

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Anthropometric measurements

All patients undergo anthropometric measurements to record body weight, body height and waist circumference on the day of enrollment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lotung Poh-Ai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lotung Poh-Ai Hospital

Principal Investigators

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Yao-Chun Hsu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Lotung Poh-Ai Hospital, Ilan, Taiwan

Locations

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Lotung Poh-Ai Hospital

Lotung Town, Ilan County, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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OMCP-97-009

Identifier Type: -

Identifier Source: org_study_id