Phase 4 N=60 Randomized Double-blind Health Services Research

Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy

Diabetes Mellitus, Type 2 · Obesity · Gastroparesis

Bottom Line

View on ClinicalTrials.gov: NCT06533527 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2025

Primary outcome: Primary: Presence of RGV (Residual Gastric Volume) in Stomach — 7; 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: GLP-1 medication (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: May 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Presence of RGV (Residual Gastric Volume) in Stomach	7; 1	—
PRIMARY Tracking the Use of Intubation Due to RGV	0; 0	—
PRIMARY Aspiration Events Due to RGV (Residual Gastric Volume)	0; 0	—

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

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06533527). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.