Clinical trial NCT06987669: Gastric Emptying in Healthy Volunteers and GLP-1 Agonist Users
Official title: Gastric Emptying Assessed by Gastric Ultrasound (US) in Healthy Volunteers and Semaglutide Users: Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetes Type 2
Obesity and Overweight
Keywords: agonist GLP-1
perioperative fasting
Lead sponsor: Clinica Alemana de Santiago
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Bariatric surgery
* Hiatal hernia
* Impairment to give consent

Primary outcomes:
measure: Number of patients with each Grade ( stomach content characteristics) according Perlas et al
timeFrame: 24 hours tops since the starting of the clear fluid diet
Secondary outcomes:
measure: Area of the stomach in supine and in RLD assessed by ultrasound
timeFrame: 24 hours tops since the starting of the clear fluid diet
Other outcomes:
Locations:
Study officials:
affiliation: Universidad de Toronto
name: Cristian Arzola, MD, MSc
role: STUDY_CHAIR
affiliation: Universidad de Valparaiso
name: Juan Pablo Ghiringelli
role: STUDY_DIRECTOR
affiliation: Universidad del Desarrollo
name: Miguel vega, MD
role: STUDY_DIRECTOR
References: