Gastro Esophageal RefluxNCT07199582
Association Between Obesity and Gastroesophageal Reflux Disease
An observational study of Gastro Esophageal Reflux and Obesity (Disorder), run by Assiut University.
Trial summary
Gastroesophageal reflux disease (GERD) is a chronic disorder marked by heartburn and regurgitation, resulting from the reflux of gastric acid or bile into the esophagus. Chronic acid exposure leads to mucosal inflammation, erosive esophagitis, and Barrett's esophagus, conditions that increase the risk of esophageal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro Esophageal Reflux, Obesity (Disorder)
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: obese patients aged >18 years with BMI>30 kg
Who may be able to join
- Age ≥18 years old. Obese patients (BMI ≥30 Kg/m2).
Who cannot join
- · Eosinophilic esophagitis.
- Achalasia.
- Esophageal cancer. Stomach cancer.
About this study
Gastroesophageal reflux disease (GERD) is a chronic disorder marked by heartburn and regurgitation, resulting from the reflux of gastric acid or bile into the esophagus. Chronic acid exposure leads to mucosal inflammation, erosive esophagitis, and Barrett's esophagus, conditions that increase the risk of esophageal adenocarcinoma (Badreddine RJ et al., 2010; Fass R, 2022). Obesity, defined by the World Health Organization as a body mass index (BMI) ≥30 kg/m², is recognized as a major global public health issue due to its rapidly rising prevalence and strong association with chronic disease. It is not only a cause of metabolic disorders but also a driver of systemic health complications (WHO, 2024). Obesity is linked with type 2 diabetes, cardiovascular disease, hypertension, non-alcoholic fatty liver disease, certain cancers, and sleep apnea.
Additionally, it negatively impacts psychological well-being, contributing to depression, low self-esteem, and social stigma (CDC, 2024). Evidence suggests a strong link between obesity and GERD. Studies demonstrate that obese individuals exhibit higher intra-gastric pressure, delayed esophageal transit, increased esophageal acid exposure, and a greater prevalence of defective lower esophageal sphincter function. These pathophysiological mechanisms contribute significantly to GERD development and its complications (de Vries DR et al., 2008; Cote-Daigneault J et al., 2014; Anggiansah R et al., 2013; Ayazi S et al., 2009). The rationale for this study is to explore the relationship between obesity and GERD, given the rising prevalence of obesity and its implications for gastrointestinal health. Diagnosis of GERD is primarily clinical, based on symptoms such as heartburn and regurgitation. A trial of proton pump inhibitors for 4-8 weeks is recommended in patients without alarm features. Endoscopy is indicated for those with alarm signs or refractory disease, while pH monitoring is the gold standard in uncertain cases. Manometry is reserved for pre-surgical evaluation (Katz PO et al., 2022).To study the relationship between Obesity and GERD, given the rising prevalence of obesity and its potential impact on gastrointestinal health.
- Conditions
- Gastro Esophageal Reflux, Obesity (Disorder)
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | obese patients | |
| Group B | non obese patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of obesity
the prevalence of obesity among GERD patients
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Esophageal RefluxStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Adolf Habib Khela, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199582
- Sponsor's protocol ID
- GERD and Obesity
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Obesity and Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT07199582
- Acronym / sponsor ID
- GERD and Obesity
- Conditions
- Gastro Esophageal Reflux, Obesity (Disorder)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 30 Sep 2025 (actual)
- 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.
Gastroesophageal reflux disease (GERD) is a chronic disorder marked by heartburn and regurgitation, resulting from the reflux of gastric acid or bile into the esophagus. Chronic acid exposure leads to mucosal inflammation, erosive esophagitis, and Barrett's esophagus, conditions that increase the risk of esophageal adenocarcinoma (Badreddine RJ et al., 2010; Fass R, 2022). Obesity, defined by the World Health Organization as a body mass index (BMI) ≥30 kg/m², is recognized as a major global public health issue due to its rapidly rising prevalence and strong association with chronic disease. It is not only a cause of metabolic disorders but also a driver of systemic health complications (WHO, 2024). Obesity is linked with type 2 diabetes, cardiovascular disease, hypertension, non-alcoholic fatty liver disease, certain cancers, and sleep apnea.
Additionally, it negatively impacts psychological well-being, contributing to depression, low self-esteem, and social stigma (CDC, 2024). Evidence suggests a strong link between obesity and GERD. Studies demonstrate that obese individuals exhibit higher intra-gastric pressure, delayed esophageal transit, increased esophageal acid exposure, and a greater prevalence of defective lower esophageal sphincter function. These pathophysiological mechanisms contribute significantly to GERD development and its complications (de Vries DR et al., 2008; Cote-Daigneault J et al., 2014; Anggiansah R et al., 2013; Ayazi S et al., 2009). The rationale for this study is to explore the relationship between obesity and GERD, given the rising prevalence of obesity and its implications for gastrointestinal health. Diagnosis of GERD is primarily clinical, based on symptoms such as heartburn and regurgitation. A trial of proton pump inhibitors for 4-8 weeks is recommended in patients without alarm features. Endoscopy is indicated for those with alarm signs or refractory disease, while pH monitoring is the gold standard in uncertain cases. Manometry is reserved for pre-surgical evaluation (Katz PO et al., 2022).To study the relationship between Obesity and GERD, given the rising prevalence of obesity and its potential impact on gastrointestinal health.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –obese patients |
| Group B | – | –non obese patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- obese patients aged >18 years with BMI>30 kg
Key inclusion criteria (1 listed)
- Age ≥18 years old. Obese patients (BMI ≥30 Kg/m2).
Key exclusion criteria (3 listed)
- · Eosinophilic esophagitis.
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
prevalence of obesity
Time frame: Baseline
the prevalence of obesity among GERD patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
Related trials for Gastro Esophageal Reflux
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Enrolling by invitation
Endoscopic Treatment of Gastroesophageal Reflux Disease
Gastro Esophageal Reflux Disease
Enrolling by invitationObservational study
Assessment of Esophageal Epithelium Integrity With Use of a Novel Mucosal Impedance Device
Gastro Esophageal Reflux
RecruitingObservational study
Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU
Stress Ulcers, Reflux Episodes
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.
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 and Obesity (Disorder), run by Assiut University.
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 3 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: opening soon, as of the sponsor's last update on 30 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
prevalence of obesity (time frame: Baseline). 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 30 Sep 2025.