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NCT Number: NCT07199582

Association Between Obesity and Gastroesophageal Reflux Disease

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. prevalence of obesity

    Time frame: Baseline

    the prevalence of obesity among GERD patients

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 30, 2025
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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