Clinical trial NCT00698178: Waist Circumference Versus Body Mass Index to Predict Severity of Gastroesophageal Reflux Disease
Official title: Waist Circumference Versus Body Mass Index to Predict Severity of Gastroesophageal Reflux Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Obesity
Keywords: Gastroesophageal reflux disease
Waist circumference
Body mass index
Obesity
Lead sponsor: Lotung Poh-Ai Hospital
Sponsor class: OTHER
First posted: 2008-06-17
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatients at a general hospital with 1000 beds in north-eastern Taiwan

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: the degree fo erosive esophagitis according to Los-Angels classification
timeFrame: on the day of endoscopy examination
Secondary outcomes:
measure: gastro-reflux severity score as evaluated by standardized questionnaire
timeFrame: at enrollment (before upper GI endoscopy)
Other outcomes:
Locations:
city: Lotung Town, Ilan County
country: Taiwan
facility: Lotung Poh-Ai Hospital
Study officials:
affiliation: Lotung Poh-Ai Hospital, Ilan, Taiwan
name: Yao-Chun Hsu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: