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

NCT07006142 | Recruiting

• 1 other identifier: 23-013192
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Endoscopy; GLP1-R-related Disease

Keywords

GLP1 receptor agonists; upper endoscopy

Outcome Measures

Primary Outcomes (1)

• Gastric contents

  Number of patients who were found to have gastric contents within the stomach during the upper endoscopy.

  Baseline

Secondary Outcomes (3)

• Diagnosis of aspiration within 72 hours of procedure

  From the time of upper endoscopy until 72 hours post-procedure.

• Aspiration pneumonitis diagnosis postoperatively

  72 hours after completion of upper endoscopy

• Postprocedural ICU admission

  Immediately after upper endoscopy

Study Arms (3)

Normal fasting guidelines and not taking GLP1-RAs

NO INTERVENTION

Patients who are not taking GLP1 RAs (Receptor Agonists) and who will abide by the normal fasting guidelines

Normal fasting guidelines with GLP1-RAs

NO INTERVENTION

Patients who are taking GLP1 RAs (Receptor Agonists) for either diabetes or weight loss management who will abide by normal fasting guidelines

Modified fasting guidelines with GLP1-RAs

EXPERIMENTAL

Patients who are prescribed and taking GLP1 RAs (Receptor Agonists) for either diabetes or weight loss management who follow the modified fasting guidelines. Modified fasting consists of a full-liquid diet 48 hours prior to the procedures, clear liquid diet 24 hours prior to their procedure, and nothing by mouth (NPO) after midnight on the day of their procedure.

Other: Modified Fasting Guidelines

Interventions

Modified Fasting Guidelines OTHER

Patients will follow a full-liquid diet 48 hours prior to their procedure, clear liquid diet 24 hours prior to their procedure, and nothing by mouth (NPO) after midnight on the day of their procedure

Modified fasting guidelines with GLP1-RAs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective upper endoscopy with gastroenterology team

You may not qualify if:

• Urgent or emergent 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Central Study Contacts

Krishnan Ramanujan, MD

CONTACT

507-422-4898; ramanujan.krishnan@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study has 3 arms, but two of them are historical cohorts (i.e. previous patients who have already been taken care of). One group will consist of patients who are not on GLP1 medications who underwent upper endoscopy, and another group will consist of patients who are on GLP1 medications who underwent upper endoscopy. The third group is the prospective group who are being enrolled and recruited - this group will consist of patients who are on GLP1 medications who abide by a modified fasting guideline consisting of a full-liquid diet 48 hours prior to procedure, clear liquid diet 24 hours prior to procedure, and no liquids or solids after midnight on the day of upper endoscopy.

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 5, 2025
• Study Start: August 1, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)