Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy

Completed · Phase 4

Conditions studied: Diabetes Mellitus, Type 2, Obesity, Gastroparesis

In brief

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

Key facts

Study ID

NCT06533527

Run by

The Cleveland Clinic

People needed

69

Starts

2024-07-31

Expected to finish

2025-05-20

Last updated by the study team

2025-12-05

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cleveland Clinic — Weston, Florida, United States
• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.