Gastric Emptying in Healthy Volunteers and GLP-1 Agonist Users

NCT ID: NCT06987669

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 155 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-17
• Study Completion Date: 2027-12-31

Brief Summary

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.

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.

Conditions

Diabetes Type 2; Obesity and Overweight

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy volunteers after high fat standardized breakfast

GUS will be made

Gastric Ultrasound

Intervention Type: DIAGNOSTIC_TEST

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)

Patients on GLP-1 agonist

Patients on GLP-1 agonist after clear fluids diet of 18/24 hrs. GUS will be made.

Gastric Ultrasound

Intervention Type: DIAGNOSTIC_TEST

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)

Interventions

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)

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

GUS

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Bariatric surgery
• Hiatal hernia
• Impairment to give consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clinica Alemana de Santiago

OTHER

Sponsor Role: lead

Responsible Party

Javiera Vargas

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cristian Arzola, MD, MSc

Role: STUDY_CHAIR

Universidad de Toronto

Juan Pablo Ghiringelli

Role: STUDY_DIRECTOR

Universidad de Valparaiso

Miguel vega, MD

Role: STUDY_DIRECTOR

Universidad del Desarrollo

Central Contacts

Javiera Vargas, MD, MSc

Role: CONTACT

jpvargasz@gmail.com

+56957383772

Other Identifiers

2024-100

Identifier Type: OTHER

Identifier Source: secondary_id

ID1406

Identifier Type: -

Identifier Source: org_study_id