Waist Circumference Versus Body Mass Index to Predict Sev... | NCT00698178

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

NCT00698178

Sponsor

Lotung Poh-Ai Hospital

Status

Completed

Last Update Posted

Oct 19, 2010Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Gastroesophageal Reflux Disease
Obesity

Interventions

Anthropometric measurements

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Jul 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Jun 13, 2008

First Submission Date that Met QC Criteria

Jun 16, 2008

First Posted Date

Jun 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2010

Last Update Posted Date

Oct 19, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
NERD	patients with typical gastro-reflux symptoms but no erosions were discernible on upper gastrointestinal endoscopy	Other: Anthropometric measurements
EE	Patients with both typical gastroesophageal reflux symptoms and characteristic flam-like erosions as demonstrated on upper gastrointestinal endoscopy	Other: Anthropometric measurements
FD	Patients report no typical reflux symptoms but fulfill diagnostic criteria of functional dyspepsia, whose upper gastrointestinal endoscopy are negative.	Other: Anthropometric measurements

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anthropometric measurements	Other	All patients undergo anthropometric measurements to record body weight, body height and waist circumference on the day of enrollment	EE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the degree fo erosive esophagitis according to Los-Angels classification		on the day of endoscopy examination

Secondary Outcomes

Measure	Description	Time Frame
gastro-reflux severity score as evaluated by standardized questionnaire		at enrollment (before upper GI endoscopy)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yao-Chun Hsu, M.D.	Lotung Poh-Ai Hospital, Ilan, Taiwan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lotung Poh-Ai Hospital		Lotung Town, Ilan County		265	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux
D009765	Obesity

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided