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Gastric Emptying in Healthy Volunteers and GLP-1 Agonist Users (aGLP1-GUS) 155 Observational Dietary

Not yet recruiting
Clinical Trial NCT06987669 (aGLP1-GUS) is an observational study for Diabetes Type 2, Obesity and Overweight and is currently not yet recruiting. Enrollment is planned to begin on May 17, 2025 and continue until the study accrues 155 participants. Led by Clinica Alemana de Santiago, this study is expected to complete by December 31, 2027. The latest data from ClinicalTrials.gov was last updated on May 23, 2025.
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 ...
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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 outpatien...

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Official Title

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

Conditions
Diabetes Type 2Obesity and Overweight
Other Study IDs
  • aGLP1-GUS
  • ID1406
  • 2024-100 (Other Identifier) (Comité Etico Cientifico Facultad de Medicina Universidad del Desarrollo Clínica Alemana)
NCT ID Number
NCT06987669
Start Date (Actual)
2025-05-17
Last Update Posted
2025-05-23
Completion Date (Estimated)
2027-12-31
Enrollment (Estimated)
155
Study Type
Observational
Status
Not yet recruiting
Keywords
agonist GLP-1
perioperative fasting
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Healthy volunteers after high fat standardized breakfast
GUS will be made
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)
Patients on GLP-1 agonist
Patients on GLP-1 agonist after clear fluids diet of 18/24 hrs. GUS will be made.
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)
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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).
24 hours tops since the starting of the clear fluid diet
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 18 years old or older
  • Healthy volunteers or semaglutide users

  • Bariatric surgery
  • Hiatal hernia
  • Impairment to give consent
Clinica Alemana de Santiago logoClinica Alemana de Santiago
Study Responsible Party
Javiera Vargas, Principal Investigator, Medical Doctor, Clinica Alemana de Santiago
Study Central Contact
Contact: Javiera Vargas, MD, MSc, +56957383772, [email protected]
No location data.