Gastric Emptying in Healthy Volunteers and GLP-1 Agonist Users (aGLP1-GUS)

May 22, 2025 updated by: Javiera Vargas, Clinica Alemana de Santiago

Gastric Emptying Assessed by Gastric Ultrasound (US) in Healthy Volunteers and Semaglutide Users: Cohort Study

This observational study aims to determine the gastric emptying kinetics assessed by ultrasound in healthy volunteers after a standard breakfast and the state of the stomach after a clear liquid diet for 18 /24 hours in patients on GLP-1 agonist. The main questions it seeks to answer are:

  • Is the kinetic after a standard breakfast that includes ( avocado and eggs: high fat) as fast as a standard meal that does not involve this food?
  • Is a clear liquid diet of 18 to 24 hours enough to be an empty-stomach, assessed by Ultrasound in patients on GLP1 agonist?

Participants will be asked to do:

-A baseline Gastric US will be performed for healthy volunteers, and then they will have a standardized breakfast. An hourly or bihourly assessment will be done by the US.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

GLP-1 analogues enhance insulin secretion from β-cells, reduce glucagon secretion, have an appetite-suppressing effect, and delay gastric emptying. This last effect may make standard preoperative fasting inadequate, compromising airway safety during elective surgery and increasing aspiration risk.

The main goal is to gather evidence to determine the optimal fasting period and dietary regimen to ensure safe outpatient surgery without increasing the risk of aspiration.Ultrasound gastric content assessment is a highly accessible, bedside, cost-free, and low-risk tool for anesthesiologists. The increased use of these drugs in surgical patients and the lack of international consensus on their discontinuation and fasting protocols before surgery necessitate further study. Our hypothesis is that GLP-1 analogue users (for weight loss or diabetes) have significantly slower gastric emptying, but a 24-hour liquid regimen may be sufficient to ensure an empty stomach and safe elective surgery.

Study Type

Observational

Enrollment (Estimated)

155

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers will be assessed for emptying the stomach after a standardized high-fat meal, by ultrasound.

Cohort of patients on a GLP-1 agonist after 18/24 hours of clear fluids.

Description

Inclusion Criteria:

  • 18 years old or older
  • Healthy volunteers or semaglutide users

Exclusion Criteria:

  • Bariatric surgery
  • Hiatal hernia
  • Impairment to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy volunteers after high fat standardized breakfast
GUS will be made
Diagnostic test: Gastric Ultrasound
A gastric ultrasound will be performed to determine the state of the stomach. Empty, clear fluids, solid, and in case of fluid, the amount of it ( using free tracing)
Other Names:
  • GUS
Patients on GLP-1 agonist
Patients on GLP-1 agonist after clear fluids diet of 18/24 hrs. GUS will be made.
Diagnostic test: Gastric Ultrasound
A gastric ultrasound will be performed to determine the state of the stomach. Empty, clear fluids, solid, and in case of fluid, the amount of it ( using free tracing)
Other Names:
  • GUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with each Grade ( stomach content characteristics) according Perlas et al
Time Frame: 24 hours tops since the starting of the clear fluid diet
Grade 0 ( empty in supine and RLD), Grade 1 ( empty supine but liquid content on RDL), Grade 3 ( Solid content or fluid with an area of more than or equal to 10 cm2).
24 hours tops since the starting of the clear fluid diet

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area of the stomach in supine and in RLD assessed by ultrasound
Time Frame: 24 hours tops since the starting of the clear fluid diet
Grade 0 ( empty in supine and RLD), Grade 1 ( empty supine but liquid content on RDL), Grade 3 ( Solid content or fluid with an area of more than or equal to 10 cm2).
24 hours tops since the starting of the clear fluid diet

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Alemana de Santiago

Investigators

  • Study Chair: Cristian Arzola, MD, MSc, Universidad de Toronto
  • Study Director: Juan Pablo Ghiringelli, Universidad de Valparaiso
  • Study Director: Miguel vega, MD, Universidad del Desarrollo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 17, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 8, 2025

First Submitted That Met QC Criteria

May 22, 2025

First Posted (Actual)

May 23, 2025

Study Record Updates

Last Update Posted (Actual)

May 23, 2025

Last Update Submitted That Met QC Criteria

May 22, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID1406
  • 2024-100 (Comité Etico Cientifico Facultad de Medicina Universidad del Desarrollo Clínica Alemana)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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