Effect of Prolonged Fasting Time on Gastric Residual Volume in Patients Taking GLP1 Receptor Agonists

Not Applicable

Recruiting

• Conditions: Upper Endoscopy; GLP1-R-related Disease

• Registration Number: NCT07006142
• Lead Sponsor: Mayo Clinic

Brief Summary

The aim of this study is to determine whether a modified fasting protocol can reduce the potential risk of aspiration for patients currently prescribed GLP1-RAs.

Detailed Description

The overall objective of this project is to identify a reasonable means by which patients on GLP1-RAs can be safely cared for in the perioperative period that can be agreed upon by all groups involved in perioperative patient care. This will be assessed in patients undergoing upper endoscopy specifically since assessment of gastric contents would be minimally invasive for this patient population receiving anesthetic care.

Study Timeline

• Study First Submitted: 2025-05-27
• Study First Submitted QC: 2025-05-27
• Study First Posted: 2025-06-05
• Status Verified: 2025-08
• Study Start: 2025-08-01
• Last Update Submitted: 2025-08-04
• Last Update Posted: 2025-08-07
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients undergoing elective upper endoscopy with gastroenterology team

Exclusion Criteria

• Urgent or emergent procedure
• Inclusion of colonoscopy or antegrade small bowel enteroscopy in planned procedure
• Upper GI barium study performed in past 24 hours.
• Gastroparesis
• Achalasia
• Pancreatitis
• Use of outpatient pro-motility medications
• Patient refusal
• Inability for patient to provide own consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Gastric contents	Baseline	Number of patients who were found to have gastric contents within the stomach during the upper endoscopy.

Secondary Outcome Measures

Name	Time	Method
Diagnosis of aspiration within 72 hours of procedure	From the time of upper endoscopy until 72 hours post-procedure.	Whether or not a patient was diagnosed with aspiration will be determined via chart review for 72 hours after the completion of upper endoscopy. A note documenting aspiration or an ICD code associated with aspiration will indicate that this outcome occurred.
Aspiration pneumonitis diagnosis postoperatively	72 hours after completion of upper endoscopy	The number of patients who have a diagnosis of aspiration pneumonitis, as identified by the presence of ICD codes J69.0 or J69.8, postoperatively.
Postprocedural ICU admission	Immediately after upper endoscopy	The number of patients who were admitted to the ICU immediately after upper endoscopy.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States