GLP-1 Receptor Agonist Use and Incidence of Retained Gastric Food on Endoscopy

This study will enroll patients ages 18 and over who are in one of the following groups 1) taking a GLP-1 receptor agonist medication 2) not taking a GLP-1 receptor agonist (control group), are undergoing EGS and have appropriately fasted. Study data will be collected in the form of qualitatively observing whether the stomach is empty as expected, or contains solid or clinically relevant liquid contents.

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Key information

Conditions

Gastric Content Aspiration Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Laryngopharyngeal Reflux Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Aspiration of Gastric Contents Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29424, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Adults 18 years of age and older presenting for esophagogastroduodenoscopy (EGD)
One of the following groups:

GLP-1 receptor agonist cohort: active treatment with any GLP-1 receptor agonist therapy within prior 30 days
Control cohort: not taking a GLP-1 receptor agonist medication
Appropriately fasted per ASA Fasting Guidelines

Exclusion criteria

Simultaneous bowel preparation/planned dual endoscopy with colonoscopy
Any pre-planned alteration to standard fasting guidelines (ASA NPO guidelines)
Emergency endoscopic procedure
Concern for active GI bleeding
Food impaction/foreign body as indication for procedure
Gastric outlet obstruction/bowel obstruction
Achalasia
Zenker's diverticulum
History of esophageal or gastric surgery
Active pregnancy
Chronic daily opioid therapy ≥ 15 MMEs per day
Prokinetic agent use (i.e. metoclopramide)
Inability or unwillingness of subject to give informed consent

Treatment and study plan

Esophagogastroduodenoscopy

Other

All patients will undergo an esophagogastroduodenoscopy per standard of care, as scheduled.

Primary outcomes

Retained gastric food

Time frame: From time of enrollment until the end of surgery, assessed up to 4 weeks

Incidence of clinically significant retained gastric food, defined as visible solid/particulate matter, or liquid volume > 1.5cc/kg

Secondary outcomes

Incidence of pulmonary aspiration event

Time frame: From the time surgery begins until the end of scheduled surgery, assessed up to 24 hours

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: May 25, 2023
Registry last updated: Sep 19, 2024

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.

Published trials that share one or more normalized conditions with this study.

Completed