NCT01560598

Brief Summary

We aimed to risk faoctors for GERD and association between visceral obesity, plasma adipoline(leptin, adiponectin, IL-6, TNF-α)and development of reflux esophagitis in healthy Koreans.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Last Updated

March 22, 2012

Status Verified

March 1, 2012

Enrollment Period

1 year

First QC Date

March 20, 2012

Last Update Submit

March 21, 2012

Conditions

Visceral ObesityReflux Esophagitis

Keywords

GERDreflux esophagitisadipokineespeciallyendoscopically proven

Outcome Measures

Primary Outcomes (1)

  • Difference in serum adipokine levels between case and control groups

    2 month lager (after sampling)

Study Arms (2)

Reflux esophagitis

those with endoscopically proven reflux esophagitis

Normal

those with normal GFS finding (without definite mucosal break at Z-line)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy adults who visit healthcare system for routine checkup

You may qualify if:

  • endoscopically proven reflux esophagitis

You may not qualify if:

  • those with esophageal hiatal hernia, current PPI medication, upper GI operation history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital Healthcare System Gangnam Center

Seoul, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Obesity, AbdominalEsophagitis, PepticGastroesophageal Reflux

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsEsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisPeptic UlcerDuodenal DiseasesIntestinal DiseasesStomach DiseasesEsophageal Motility DisordersDeglutition Disorders

Central Study Contacts

Kyung-Sang Yu, Professor

CONTACT

+82-2-2072-1920ksyu@snu.ac.kr

Jeong-Hwa Hong, IRB analyst

CONTACT

+82-2-740-8096jhhong@snu.ac.kr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

March 20, 2012

First Posted

March 22, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2013

Last Updated

March 22, 2012

Record last verified: 2012-03

Locations

KR(1)