Protective Benefits of a Clear Liquid Diet on Residual Gastric Content in Patients Taking Glucagon Like Peptide-1 Receptor (GLP-1 RA) Agonist Prior to Anesthesia

Protective Benefits of a Clear Liquid Diet on Residual Gastric Content in Patients Taking Glucagon Like Peptide-1 Receptor Agonist Prior to Anesthesia

The purpose of this study is to determine if prolonged fasting from solids and transitioning to a CLD for 24 hours is protective to decrease RGC in patients on GLP-1 RAs presenting for upper endoscopy, to determine if prolonged fasting is associated with increased thirst, hunger and anxiety, To determine if signs and symptoms of nausea, vomiting, retching, abdominal bloating, and abdominal pain are present on the day of surgery, to see if there is any variability between preoperative gastric ultrasound assessment and volume of gastric contents visualized on upper endoscopy, to determine time of gastric emptying by serial Gastric ultrasonography (GUS) scans every 2 hours in subjects who presented with an initial at-risk scan, to determine the choice of anesthesia used based on preoperative GUS results, to determine if there were any adverse events recorded in this study group, to determine if duration of GLP-1 RA therapy has an association with residual gastric content (RGC). and to determine if dosing of GLP-1 RA has an association with RGC.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Aspiration
• Intervention / Treatment: Other: GLP-1 RA users with prolonged fasting instructions; Other: GLP-1 RA users with standard NPO instructions

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sudipta Sen, MD, FASA; Phone Number: (713) 500-6202; Email: Sudipta.Sen@uth.tmc.edu
• Study Contact Backup: Name: Paul Potnuru; Phone Number: (713) 500-6271; Email: Paul.Potnuru@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Sudipta Sen, MD, FASA; Phone Number: (713) 500-6202; Email: Sudipta.Sen@uth.tmc.edu
      • Contact: Paul Potnuru; Phone Number: (713) 500-6271; Email: Paul.Potnuru@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients taking Glucagon Like Peptide-1 Receptor (GLP-1 RA) agonists
• Undergoing upper endoscopy only - no colonoscopy due to prep

Exclusion Criteria:

• Previous gastric resection or bypass
• Gastric band in situ
• Previous fundoplication
• Large hiatal hernia
• Pregnant patients
• Recent trauma
• Inability to turn to the right lateral decubitus position.
• Patients on erythromycin, metoclopramide, domperidone, opioids.
• Gastroparesis previous

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GLP-1 RA users with prolonged fasting instructions	Other: GLP-1 RA users with prolonged fasting instructions; NPO for solids: 24 hours prior to procedure, clear liquid diet (CLD) for 24 hours with last intake of clears no less than 2 hours prior to a procedure.GLP-1 RA will not be held prior to surgery and usual dosing schedule will be followed prior to procedure.
Active Comparator: GLP-1 RA users with standard NPO instructions	Other: GLP-1 RA users with standard NPO instructions; NPO after midnight prior to procedure; Minimum solid fasting duration of 8 hours for solids and 2 hours for liquids. Last dose of GLP-1 RA no less than 7 days prior to procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants that show prevalence of increased RGC determined using preoperative GUS	Participants with increased RGC will have solids, thick fluid, or clear fluids >1.5ml/kg in the gastric antrum in the right lateral decubitus position	prior to procedure ( within 2 hours before procedure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants that show thirst as assessed by the VAS	This is measured in a linear scale from 1-10, higher number showing worse outcome	prior to procedure ( within 2 hours before procedure)
Number of participants that show hunger as assessed by the VAS	This is measured in a linear scale from 1-10, higher number showing worse outcome	prior to procedure ( within 2 hours before procedure)
Number of participants that show anxiety as assessed by the VAS	This is measured in a linear scale from 1-10, higher number showing worse outcome	prior to procedure ( within 2 hours before procedure)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Sudipta Sen, MD, FASA, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Estimated): November 3, 2025
• Last Update Submitted That Met QC Criteria: October 30, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: full stomach; Glucagon Like Peptide-1 Receptor (GLP-1 RA)
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Glucagon; Glucagon-Like Peptide 1
• Other Study ID Numbers: HSC-MS-24-0940

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No