NCT07251803

Brief Summary

This study will enroll patients 18 years and older who are taking a GLP-1/GIP medication and 1) are scheduled for elective surgery and meet ASA fasting guidelines (nothing by mouth for at least 8 hours prior), or 2) scheduled elective colonoscopy and have been on a clear liquid diet for at least 24 hours prior. Participants will have a gastric ultrasound prior to surgery to measure any retained gastric contents. The purpose of this study is to determine if people taking GLP-1 receptor agonists and who fast normally are at an equal risk for having retained gastric contents after appropriately fasting for surgery, compared to patients who are on a liquid only diet for 24 hours prior to surgery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

November 11, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 3, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

November 11, 2025

Last Update Submit

February 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pre-operative gastric volume per unit of weight (ml/kg) as assessed by gastric ultrasound.

    While the patient is in supine position, the gastric volume will be measured via ultrasound and then calculated using a validated formula, GV (mL) = 27.0+(14.6\*CSA)-(1.28\*age).

    From enrollment until completion of pre-operative gastric ultrasound (typically within 3 hours of scheduled procedure).

Secondary Outcomes (5)

  • Perlas antral grade

    From enrollment until completion of gastric ultrasound (within 3 hours of scheduled procedure).

  • Incidence of full stomach on gastric ultrasound assessment

    From time of enrollment until the start of surgery, up to 24 hours.

  • Incidence of regurgitation under anesthesia

    From induction of anesthesia until end of surgery (up to 8 hours).

  • Incidence of change in anesthetic management based on stomach contents

    Assessed at enrollment and during gastric ultrasound (within 3 hours of scheduled procedure).

  • Differences in "high risk GLP-1" vs "low risk GLP-1"

    assessed at time of enrollment from the past 30 days until completion of gastric ultrasound

Study Arms (2)

ASA fasting guidelines

Scheduled elective surgery and meet ASA fasting guidelines (NPO for at least 8 hours prior)

Diagnostic Test: Gastric Ultrasound

24-hour clear liquid diet

Scheduled elective colonoscopy and have been on a clear liquid diet for at least 24 hours prior

Diagnostic Test: Gastric Ultrasound

Interventions

Gastric UltrasoundDIAGNOSTIC_TEST

All participants will undergo a gastric ultrasound in the preoperative area prior to their scheduled procedure. The patient will be placed in supine position. A curvilinear ultrasound probe will be placed on the sagittal plane below the xiphoid process. The probe will then slide along the costal margin to the right until the gastric antrum is identified. At this point, the ultrasound image will be obtained, and appropriate measurements will be taken. The patient will be placed in the right lateral decubitus position (RLD), and the above procedure will be repeated. The measurement of gastric antral cross-sectional area while in the RLD position will be recorded and used to calculate the gastric volume.

24-hour clear liquid dietASA fasting guidelines

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will consist of patients who have taken a GLP-1 or GLP-GIP agonist medication within the past 30 days, and are scheduled for either an elective surgery and appropriately NPO for at least 8 hours prior, or scheduled for elective colonoscopy and have been on a clear liquid diet for at least 24 hours prior.

You may qualify if:

  • Age 18+
  • Have taken a GLP-1 or GLP-GIP agonist medication within the past 30 days
  • ASA Physical Classification Status 1-3
  • Fall into one of the following groups:
  • Scheduled elective surgery and meet ASA fasting guidelines (NPO for at least 8 hours prior)
  • Scheduled elective colonoscopy and have been on a clear liquid diet for at least 24 hours prior

You may not qualify if:

  • Previous gastric or esophageal surgery
  • Abnormal gastric anatomy
  • Pregnancy
  • Unable to provide written, informed consent
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Study Officials

  • Christopher Wolla, M.D.

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haley Nitchie, MHA

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor-Faculty

Study Record Dates

First Submitted

November 11, 2025

First Posted

November 26, 2025

Study Start

February 3, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations