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Adipokines and the Risk of Reflux Esophagitis

This study is not yet open for participant recruitment.
Verified March 2012 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Donghee Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01560598
First received: March 20, 2012
Last updated: March 21, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition
Visceral Obesity
Reflux Esophagitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Adipokines and the Risk of Reflux Esophagitis : Prospective Case-control Study

Resource links provided by NLM:

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

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Difference in serum adipokine levels between case and control groups [ Time Frame: 2 month lager (after sampling) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum


Estimated Enrollment: 600
Study Start Date: June 2012
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Reflux esophagitis
those with endoscopically proven reflux esophagitis
Normal
those with normal GFS finding (without definite mucosal break at Z-line)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

healthy adults who visit healthcare system for routine checkup

Criteria

Inclusion Criteria:

  • endoscopically proven reflux esophagitis

Exclusion Criteria:

  • those with esophageal hiatal hernia, current PPI medication, upper GI operation history
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560598

Contacts
Contact: Kyung-Sang Yu, Professor +82-2-2072-1920 ksyu@snu.ac.kr
Contact: Jeong-Hwa Hong, IRB analyst +82-2-740-8096 jhhong@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Healthcare System Gangnam Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Su Jin Chung, MD     +82-10-8424-8471     medjsj7@hanmail.net    
Principal Investigator: Donghee Kim, MD            
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Donghee Kim, Clinical Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01560598     History of Changes
Other Study ID Numbers: gerdadipokine
Study First Received: March 20, 2012
Last Updated: March 21, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
GERD
reflux esophagitis
adipokine
especially
endoscopically proven

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

ClinicalTrials.gov processed this record on May 23, 2013