Gastro-esophageal Reflux Disease With Ulceration.NCT02888808
Relationship of Obesity With GERD Among Nigerians
An observational study of Gastro-esophageal Reflux Disease With Ulceration., run by Obafemi Awolowo University Teaching Hospital.
Trial summary
Obesity is a strong risk factor for GERD. This study assessed the role of obesity among patients having erosive GERD and controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro-esophageal Reflux Disease With Ulceration.
- What is being tested?
- Gastroscopy
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Nigerians with dyspeptic symptoms
Who may be able to join
- Patients with dyspepsia
Who cannot join
- Patients that refused consent.
- Patients with gastric cancer
- Patients with gastric outlet obstruction
- Pregnant women
- Active gastrointestinal bleeding
- Cigarette smokers
- Patients on Naso-gastric tube.
About this study
Official title: Relationship Between Body Mass Index, Waist Circumference, Waist Hip Ratio and Erosive Gastroesophageal Reflux Disease in a Tertiary Centre in Nigeria: a Case Control Study
Obesity is a strong risk factor for GERD. This study assessed the role of obesity among patients having erosive GERD and controls.
Read the detailed description
A case control study of patients with erosive GERD. Patients with erosive GERD who had upper gastro-intestinal endoscopy were graded using the Los Angeles classification. Patients and controls had measurements of body mass index (BMI), WC (waist circumference), Waist hip ratio (WHR), and hip circumference (HC). Bio-data was collected from both groups and data were analysed using descriptive and inferential statistics. A p value of equal to or less than 0.05 was considered significant.
- Being tested
- Gastroscopy
- Keywords
- gastroesophageal reflux disease, women, Nigeria, obesity
- Medical subject headings
- Gastroesophageal Reflux, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastroscopyOther
Upper gastrointestinal endoscopy procedure
| Study group | Role | What they receive |
|---|---|---|
| Erosive GERD | Gastroscopy examination. Receives: Other: Gastroscopy | |
| Control population | Gastroscopy examination. Receives: Other: Gastroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obesity associated with GERD
Measurement of anthropometric indices
Measured: Immediate.
Secondary outcomes (3)
Body mass index is associated with GERD
Measurement of body mass index (kilogram per meter squared)
Measured: Immediate
Waist circumference is associated with GERD
Measurement of waist circumference (centimeter)
Measured: Immediate
Waist hip ratio is associated with GERD
Measurement of waist hip ratio
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startMar 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-esophageal Reflux Disease With Ulceration.Studies of the same condition, open and under way.
- 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obafemi Awolowo University Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olusegun Adekanle, Obafemi Awolowo University Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888808
- Sponsor's protocol ID
- ERC/2009/03/07
- Status last verified
- Aug 2016
- First submitted
- 12 Aug 2016
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Body Mass Index, Waist Circumference, Waist Hip Ratio and Erosive Gastroesophageal Reflux Disease in a Tertiary Centre in Nigeria: a Case Control Study
- ClinicalTrials.gov ID
- NCT02888808
- Acronym / sponsor ID
- ERC/2009/03/07
- Keywords
- gastroesophageal reflux disease, women, Nigeria, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Obafemi Awolowo University Teaching HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Sep 2016 (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.
Obesity is a strong risk factor for GERD. This study assessed the role of obesity among patients having erosive GERD and controls.
Detailed description
A case control study of patients with erosive GERD. Patients with erosive GERD who had upper gastro-intestinal endoscopy were graded using the Los Angeles classification. Patients and controls had measurements of body mass index (BMI), WC (waist circumference), Waist hip ratio (WHR), and hip circumference (HC). Bio-data was collected from both groups and data were analysed using descriptive and inferential statistics. A p value of equal to or less than 0.05 was considered significant.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erosive GERD | – | Other: GastroscopyGastroscopy examination. |
| Control population | – | Other: GastroscopyGastroscopy examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nigerians with dyspeptic symptoms
Key inclusion criteria (1 listed)
- Patients with dyspepsia
Key exclusion criteria (7 listed)
- Patients that refused consent.
- Patients with gastric cancer
- Patients with gastric outlet obstruction
- Pregnant women
- Active gastrointestinal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GastroscopyUpper gastrointestinal endoscopy procedure | Other | Control population, Erosive GERD |
Primary outcome
Obesity associated with GERD
Time frame: Immediate.
Measurement of anthropometric indices
3 secondary outcomes
Body mass index is associated with GERD
Time frame: Immediate
Waist circumference is associated with GERD
Time frame: Immediate
Waist hip ratio is associated with GERD
Time frame: Immediate
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 5 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastro-esophageal Reflux Disease With Ulceration., run by Obafemi Awolowo University Teaching Hospital.
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 7 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 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Obesity associated with GERD (time frame: Immediate.). 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 5 Sep 2016.