Adipokines and the Risk of Reflux Esophagitis | NCT01560598

Studies
Adipokines and the Risk of Reflux Esophagitis

NCT01560598

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Mar 22, 2012Estimated

Enrollment

600Estimated

Phase

Not provided

Conditions

Visceral Obesity
Reflux Esophagitis

Interventions

Not provided

Countries

South Korea

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

Mar 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Jun 2013Estimated

Completion Date

Not provided

First Submitted Date

Mar 20, 2012

First Submission Date that Met QC Criteria

Mar 21, 2012

First Posted Date

Mar 22, 2012Estimated

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

Mar 21, 2012

Last Update Posted Date

Mar 22, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Donghee Kim, Clinical Assistant Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

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

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.

Detailed Description

Not provided

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

Retention

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Reflux esophagitis		those with endoscopically proven reflux esophagitis
Normal		those with normal GFS finding (without definite mucosal break at Z-line)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in serum adipokine levels between case and control groups		2 month lager (after sampling)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

endoscopically proven reflux esophagitis

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

healthy adults who visit healthcare system for routine checkup

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kyung-Sang Yu, Professor	Contact	+82-2-2072-1920		ksyu@snu.ac.kr
Jeong-Hwa Hong, IRB analyst	Contact	+82-2-740-8096		jhhong@snu.ac.kr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital Healthcare System Gangnam Center		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D056128	Obesity, Abdominal
D004942	Esophagitis, Peptic
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided