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NCT Number: NCT06987669

Gastric Emptying in Healthy Volunteers and GLP-1 Agonist Users

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Bariatric surgery
  • Hiatal hernia
  • Impairment to give consent

Treatment and study plan

Gastric ultrasound

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)

Other names: GUS

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Javiera Vargas, MD, MSc

CONTACT

[email protected]

+56957383772

Sponsors and collaborators

Lead sponsor

Clinica Alemana de Santiago

Other

Registry information

Official study title

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

Acronym: aGLP1-GUS

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 23, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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