Gastric Emptying in Healthy Volunteers and GLP-1 Agonist Users
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorClinica Alemana de Santiago
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18 years old or older
Healthy volunteers or semaglutide users
Disqualifiers
Bariatric surgery
Hiatal hernia
Impairment to give consent
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Gastric Ultrasound
Diagnostic testA 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)
Treatment groups
155 Participants
are divided into 2 treatment groupsGroup A: Healthy volunteers after high fat standardized breakfast1 intervention
Group B: Patients on GLP-1 agonist1 intervention
Trial outcomes
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).
Time frame
24 hours tops since the starting of the clear fluid dietSecondary outcomes
1
Area of the stomach in supine and in RLD assessed by ultrasound
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).
Time frame
24 hours tops since the starting of the clear fluid dietLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: