Gastric Emptying in Healthy Volunteers and GLP-1 Agonist Users

NCT06987669 | Not Yet Recruiting

• 2 other identifiers: ID14062024-100
• Study Type: observational
• Target: 155
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Type 2; Obesity and Overweight

Keywords

agonist GLP-1; perioperative fasting

Outcome Measures

Primary Outcomes (1)

• Number of patients with each Grade ( stomach content characteristics) according Perlas et al

  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 Outcomes (1)

• Area of the stomach in supine and in RLD assessed by ultrasound

  24 hours tops since the starting of the clear fluid diet

Study Arms (2)

Healthy volunteers after high fat standardized breakfast

GUS will be made

Diagnostic Test: Gastric Ultrasound

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

Interventions

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)

Also known as: GUS

Healthy volunteers after high fat standardized breakfast; Patients on GLP-1 agonist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years old or older
• Healthy volunteers or semaglutide users

You may not qualify if:

• Bariatric surgery
• Hiatal hernia
• Impairment to give consent

Sponsors & Collaborators

• Clinica Alemana de Santiago: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Overweight

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cristian Arzola, MD, MSc

  Universidad de Toronto

  STUDY CHAIR

• Juan Pablo Ghiringelli

  Universidad de Valparaiso

  STUDY DIRECTOR

• Miguel vega, MD

  Universidad del Desarrollo

  STUDY DIRECTOR

Central Study Contacts

Javiera Vargas, MD, MSc

CONTACT

+56957383772; jpvargasz@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 23, 2025
• Study Start: May 17, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 23, 2025

Record last verified: 2025-04