Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy

To assess whether holding incretin-based therapy before endoscopy reduces the likelihood of clinically relevant Residual Gastric Volume (RGV).

Primary Outcomes:

* Residual gastric volume that precludes adequate endoscopic examination * Residual gastric volume that necessitates premature termination of the endoscopy procedure * Need for endotracheal intubation due to stomach contents. * Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission

Secondary Outcomes:

* Presence of any solid food * Presence of moderate liquid content * Increased RGV(Residual Gastric Volume) defined as any amount of solid content or > 0.8 mL/Kg of fluid content (measured from the aspiration/suction canister). * Differences in primary and secondary outcomes between different medications

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Key information

Conditions

Diabetes Mellitus, Type 2 Body Weight Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Gastrointestinal Diseases Gastroparesis Glucose Metabolism Disorders Metabolic Diseases Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cleveland Clinic, Weston, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Patients using incretin-based therapies at a stable dose for more than 1 month.
Patients scheduled for outpatient esophagogastroduodenoscopy (EGD), endoscopic ultrasound (EUS), or endoscopic retrograde cholangiopancreatography (ERCP) under monitored anesthesia care.

Exclusion criteria

Documented history of gastroparesis (based on a 4-hour solid-phase gastric emptying study)
Known history of achalasia
Surgical or genetically altered foregut anatomy
Known gastric outlet obstruction or pre-procedure imaging suggestive of gastric outlet obstruction.
Patients who did not follow the standard NPO (nil per oral) instructions.

Treatment and study plan

GLP-1 medication

Drug

Continue taking GLP-1 as normally scheduled prior to endoscopy.

Other names: Tirzepatide, Semaglutide, Liraglutide, Dulaglutide

Primary outcomes

Presence of RGV (Residual Gastric Volume) in Stomach

Time frame: Procedure

Residual gastric volume (RGV) that precludes adequate endoscopic examination
Tracking the Use of Intubation Due to RGV

Time frame: Procedure
Aspiration Events Due to RGV (Residual Gastric Volume)

Time frame: Procedure

Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Randomized Trial of Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Aug 1, 2024
Registry last updated: Dec 5, 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.

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

Completed