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Effect of Prolonged Fasting Time on Gastric Residual Volume in Patients Taking GLP1 Receptor Agonists 150

Recruiting
Clinical Trial NCT07006142 is an interventional study for Upper Endoscopy, GLP1-R-related Disease that is recruiting. It started on 1 August 2025 with plans to enroll 150 participants. Led by Mayo Clinic, it is expected to complete by 30 April 2026. The latest data from ClinicalTrials.gov was last updated on 3 February 2026.
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 ...Show More
Official Title

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

Conditions
Upper EndoscopyGLP1-R-related Disease
Other Study IDs
  • 23-013192
NCT ID Number
Start Date (Actual)
2025-08-01
Last Update Posted
2026-02-03
Completion Date (Estimated)
2026-04-30
Enrollment (Estimated)
150
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
GLP1 receptor agonists
upper endoscopy
Primary Purpose
Prevention
Design Allocation
N/A
Interventional Model
Single Group
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
No InterventionNormal fasting guidelines and not taking GLP1-RAs
Patients who are not taking GLP1 RAs (Receptor Agonists) and who will abide by the normal fasting guidelines
N/A
No InterventionNormal fasting guidelines with GLP1-RAs
Patients who are taking GLP1 RAs (Receptor Agonists) for either diabetes or weight loss management who will abide by normal fasting guidelines
N/A
ExperimentalModified fasting guidelines with GLP1-RAs
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.
Modified Fasting Guidelines
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
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Gastric contents
Number of patients who were found to have gastric contents within the stomach during the upper endoscopy.
Baseline
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Diagnosis of aspiration within 72 hours of 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.
From the time of upper endoscopy until 72 hours post-procedure.
Aspiration pneumonitis diagnosis postoperatively
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.
72 hours after completion of upper endoscopy
Postprocedural ICU admission
The number of patients who were admitted to the ICU immediately after upper endoscopy.
Immediately after upper endoscopy
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Patients undergoing elective upper endoscopy with gastroenterology team

  • 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 Responsible Party
Krishnan Ramanujan, Principal Investigator, Principal Investigator, Mayo Clinic
Study Central Contact
Contact: Krishnan Ramanujan, MD, 507-422-4898, [email protected]
1 Study Locations in 1 Countries

Minnesota

Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States
Krishnan Ramanujan, MD, Contact, 507-422-4898, [email protected]
Recruiting