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

This study has been completed.
Sponsor:
Information provided by:
Lotung Poh-Ai Hospital
ClinicalTrials.gov Identifier:
NCT00698178
First received: June 13, 2008
Last updated: October 18, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention
Gastroesophageal Reflux Disease
Obesity
 Other: Anthropometric measurements

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Waist Circumference Versus Body Mass Index to Predict Severity of Gastroesophageal Reflux Disease

Resource links provided by NLM:

MedlinePlus related topics: GERD Obesity
U.S. FDA Resources

Further study details as provided by Lotung Poh-Ai Hospital:

Primary Outcome Measures:
  • the degree fo erosive esophagitis according to Los-Angels classification [ Time Frame: on the day of endoscopy examination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • gastro-reflux severity score as evaluated by standardized questionnaire [ Time Frame: at enrollment (before upper GI endoscopy) ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: June 2008
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
NERD
patients with typical gastro-reflux symptoms but no erosions were discernible on upper gastrointestinal endoscopy
 Other: Anthropometric measurements
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
 Other: Anthropometric measurements
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.
 Other: Anthropometric measurements
All patients undergo anthropometric measurements to record body weight, body height and waist circumference on the day of enrollment

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Outpatients at a general hospital with 1000 beds in north-eastern Taiwan

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698178

Locations
Taiwan
Lotung Poh-Ai Hospital
Lotung Town, Ilan County, Taiwan, 265
Sponsors and Collaborators
Lotung Poh-Ai Hospital
Investigators
Principal Investigator: Yao-Chun Hsu, M.D. Lotung Poh-Ai Hospital, Ilan, Taiwan
  More Information

No publications provided

Responsible Party: Hsin-Hong Chen/Superintendent, Lotung Poh-Ai Hospital
ClinicalTrials.gov Identifier: NCT00698178     History of Changes
Other Study ID Numbers: OMCP-97-009
Study First Received: June 13, 2008
Last Updated: October 18, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Lotung Poh-Ai Hospital:
Gastroesophageal reflux disease
Waist circumference
Body mass index
Obesity

Additional relevant MeSH terms:
Gastroesophageal Reflux
Obesity
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013