Recruiting

GLP-1 RAs

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06654219

Conditions

Pulmonary Aspiration

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GLP-1 RA users with prolonged fasting instructions

GLP-1 RA users with standard NPO instructions

Study Details

Brief summary:

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.

Conditions

Pulmonary Aspiration

Study ID

NCT06654219

Start date

Oct 30, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

136 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: GLP-1 RA users with prolonged fasting instructions

active comparator: GLP-1 RA users with standard NPO instructions

Interventions

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.

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.

Primary outcome measure

  • Number of participants that show prevalence of increased RGC determined using preoperative GUS [ Time Frame: prior to procedure ( within 2 hours before procedure) ]

Central Contacts and Locations

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Aug 4, 2026

Last verified

Jul, 2026

Keywords

  • Glucagon Like Peptide-1 Receptor (GLP-1 RA)
  • full stomach

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-08-04.