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Adipokines and the Risk of Reflux Esophagitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Donghee Kim, Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01560598
First Posted: March 22, 2012
Last Update Posted: March 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Donghee Kim, Seoul National University Hospital
  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:


Further study details as provided by Donghee Kim, Seoul National University Hospital:

Primary Outcome Measures:
  • Difference in serum adipokine levels between case and control groups [ Time Frame: 2 month lager (after sampling) ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Donghee Kim, Clinical Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01560598     History of Changes
Other Study ID Numbers: gerdadipokine
First Submitted: March 20, 2012
First Posted: March 22, 2012
Last Update Posted: March 22, 2012
Last Verified: March 2012

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

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophagitis
Esophagitis, Peptic
Obesity, Abdominal
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Obesity
Overnutrition
Nutrition Disorders