Visceral ObesityNCT01560598
Adipokines and the Risk of Reflux Esophagitis
An observational study of Visceral Obesity and Reflux Esophagitis, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Visceral Obesity, Reflux Esophagitis
- How many people
- 600 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy adults who visit healthcare system for routine checkup
Who may be able to join
- endoscopically proven reflux esophagitis
Who cannot join
- those with esophageal hiatal hernia, current PPI medication, upper GI operation history
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital Healthcare System Gangnam Center
Seoul
Su Jin Chung, MD, +82-10-8424-8471, medjsj7@hanmail.net
Donghee Kim, MD
About this study
Official title: Adipokines and the Risk of Reflux Esophagitis : Prospective Case-control Study
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.
- Conditions
- Visceral Obesity, Reflux Esophagitis
- Keywords
- GERD, reflux esophagitis, adipokine, especially, endoscopically proven
- Medical subject headings
- Obesity, Abdominal, Esophagitis, Peptic, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Reflux esophagitis | those with endoscopically proven reflux esophagitis | |
| Normal | those with normal GFS finding (without definite mucosal break at Z-line) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in serum adipokine levels between case and control groups
Measured: 2 month lager (after sampling)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral ObesityStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donghee Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560598
- Sponsor's protocol ID
- gerdadipokine
- Status last verified
- Mar 2012
- First submitted
- 20 Mar 2012
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipokines and the Risk of Reflux Esophagitis : Prospective Case-control Study
- ClinicalTrials.gov ID
- NCT01560598
- Acronym / sponsor ID
- gerdadipokine
- Conditions
- Visceral Obesity, Reflux Esophagitis
- Keywords
- GERD, reflux esophagitis, adipokine, especially, endoscopically proven
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (estimated)
- First posted
- 22 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reflux esophagitis | – | –those with endoscopically proven reflux esophagitis |
| Normal | – | –those with normal GFS finding (without definite mucosal break at Z-line) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy adults who visit healthcare system for routine checkup
Key inclusion criteria (1 listed)
- endoscopically proven reflux esophagitis
Key exclusion criteria (1 listed)
- those with esophageal hiatal hernia, current PPI medication, upper GI operation history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in serum adipokine levels between case and control groups
Time frame: 2 month lager (after sampling)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visceral Obesity and Reflux Esophagitis, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyung-Sang Yu, Professor (+82-2-2072-1920, ksyu@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in serum adipokine levels between case and control groups (time frame: 2 month lager (after sampling)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2012.