Association Between Obesity and Gastroesophageal Reflux Disease

NCT07199582 | Not Yet Recruiting DMC

• 1 other identifier: GERD and Obesity
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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 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)

Outcome Measures

Primary Outcomes (1)

• prevalence of obesity

  the prevalence of obesity among GERD patients

  Baseline

Study Arms (2)

Group A

obese patients

Group B

non obese patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

obese patients aged \>18 years with BMI\>30 kg

You may qualify if:

• Age ≥18 years old. Obese patients (BMI ≥30 Kg/m2).

You may not qualify if:

• · Eosinophilic esophagitis.
• Achalasia.
• Esophageal cancer. Stomach cancer.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Gastroesophageal Reflux; Obesity

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: residant doctor at Assiut university hospital

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 30, 2025

Record last verified: 2025-09