Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy
NCT Number: NCT06533527
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus, Type 2|Obesity|Gastroparesis
Interventions: DRUG: Semaglutide|DRUG: Tirzepatide|DRUG: Liraglutide|DRUG: Dulaglutide
Sponsor: The Cleveland Clinic
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-07-31
Completion Date: 2025-07
Locations: Cleveland Clinic, Weston, Florida, 33331, United States

Summary:
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

Primary Outcome Measures: Residual gastric volume(RGV) that precludes adequate endoscopic examination, Presence of RGV(Residual Gastric Volume) in stomach, Procedure|Residual gastric volume(RGV) that necessitates premature termination of the endoscopy procedure, Early termination of procedure due to high RGV(Residual Gastric Volume), Procedure|Need for endotracheal intubation due to stomach contents., Tracking the use of intubation due to RGV, Procedure|Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission, Determination of aspiration events due to RGV(Residual Gastric Volume), Procedure
Secondary Outcome Measures: Presence of any solid food, Detection of undigested food, Procedure|Presence of moderate liquid content, Detection of liquid during procedure, Procedure|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)., Quantifying RGV(residual gastric volume) during procedure, Procedure|· Differences in primary and secondary outcomes between different medications, Presence of RGV(Residual Gastric Volume) in stomach, Procedure|· Differences in primary and secondary outcomes between different medications, Early termination of procedure due to high RGV(Residual Gastric Volume), Procedure|· Differences in primary and secondary outcomes between different medications, Tracking the use of intubation due to RGV(Residual Gastric Volume), Procedure|· Differences in primary and secondary outcomes between different medications, Determination of aspiration events due to RGV(Residual Gastric Volume), Procedure|· Differences in primary and secondary outcomes between different medications, Detection of undigested food, Procedure|· Differences in primary and secondary outcomes between different medications, Detection of liquid during procedure, Procedure|· Differences in primary and secondary outcomes between different medications, Quantifying RGV(residual gastric volume) during procedure differences between different medications., Procedure