Gastroesophageal Reflux DiseaseNCT01954667
Anthropometric Measures and Severity of Gastroesophageal Reflux Disease
An observational study of Gastroesophageal Reflux Disease, run by Ain Shams University at 1 site in Egypt.
Trial summary
evaluate the impact of different anthropometric measures on clinical and endoscopic severity of GERD and its relation to serum leptin. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2012to Aug 2013
- How long will I take part?
- 6 Weeks
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This prospective, case-controlled study included 60 Egyptian patients who attended Ain Shams University Hospitals and Theodor Bilharz Research Institute; Cairo, Egypt
Who may be able to join
- Gastro esophageal reflux symptoms (e.g. heart burn, regurgitation, water brash or atypical symptoms such as hoarseness of voice, asthma and cough)
- complete upper gastrointestinal endoscopy.
Who cannot join
- Receiving medication for reflux disease (including proton pump inhibitor, histamine type 2 receptors blocker, prokinetic agents) in the previous month.
- Pregnant woman.
- History of upper abdominal surgery.
- Severe co-morbidity as cirrhosis, end-stage renal disease and heart failure.
Trial locations and contacts
1 site in 1 country.
About this study
evaluate the impact of different anthropometric measures on clinical and endoscopic severity of GERD and its relation to serum leptin.
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Gastroesophageal Reflux Disease; Anthropometric Measures; Leptin
- Medical subject headings
- 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 |
|---|---|---|
| obese and overweight | Group1 (n=30): overweight and obese (BMI ≥25 and/ or WHtR≥0.5) | |
| average body weight | Group2 (n=30): normal weight (BMI ≥ 18 to < 25 and/or WHtR ≥0.4 to <0.5) | |
| Control group | Control Group (n= 20): healthy subjects, matched for age and gender, were included in this study. All included controls had average weight (BMI ≥ 18 to < 25 and/ or WHtR ≥0.4 to <0.5) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of anthropometric measures on GERD
evaluate the impact of different anthropometric measures on clinical and endoscopic severity of GERD and its relation to serum leptin.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startJan 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- 80 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iman Fawzy Montasser, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954667
- Sponsor's protocol ID
- Anthropometric Measures &GERD
- Status last verified
- Sep 2013
- First submitted
- 29 Sep 2013
- Last updated
- 7 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anthropometric Measures and Severity of Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT01954667
- Acronym / sponsor ID
- Anthropometric Measures &GERD
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Gastroesophageal Reflux Disease; Anthropometric Measures; Leptin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 7 Oct 2013 (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.
evaluate the impact of different anthropometric measures on clinical and endoscopic severity of GERD and its relation to serum leptin.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| obese and overweight | – | –Group1 (n=30): overweight and obese (BMI ≥25 and/ or WHtR≥0.5) |
| average body weight | – | –Group2 (n=30): normal weight (BMI ≥ 18 to < 25 and/or WHtR ≥0.4 to <0.5) |
| Control group | – | –Control Group (n= 20): healthy subjects, matched for age and gender, were included in this study. All included controls had average weight (BMI ≥ 18 to < 25 and/ or WHtR ≥0.4 to <0.5) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective, case-controlled study included 60 Egyptian patients who attended Ain Shams University Hospitals and Theodor Bilharz Research Institute; Cairo, Egypt
Key inclusion criteria (2 listed)
- Gastro esophageal reflux symptoms (e.g. heart burn, regurgitation, water brash or atypical symptoms such as hoarseness of voice, asthma and cough)
- complete upper gastrointestinal endoscopy.
Key exclusion criteria (4 listed)
- Receiving medication for reflux disease (including proton pump inhibitor, histamine type 2 receptors blocker, prokinetic agents) in the previous month.
- Pregnant woman.
- History of upper abdominal surgery.
- Severe co-morbidity as cirrhosis, end-stage renal disease and heart failure.
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
Impact of anthropometric measures on GERD
Time frame: 1 year
evaluate the impact of different anthropometric measures on clinical and endoscopic severity of GERD and its relation to serum leptin.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gastroesophageal Reflux Disease, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 7 Oct 2013. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of anthropometric measures on GERD (time frame: 1 year). 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 7 Oct 2013.