Diabetes Type 2aGLP1-GUSNCT06987669
Gastric Emptying in Healthy Volunteers and GLP-1 Agonist Users
An observational study of Diabetes Type 2 and Obesity and Overweight, run by Clinica Alemana de Santiago.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Type 2, Obesity and Overweight
- What is being tested?
- Gastric Ultrasound
- How many people
- 155 participants
- Where
- No sites listed yet
- Study dates
- 17 May 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 18 years old or older
- Healthy volunteers or semaglutide users
Who cannot join
- Bariatric surgery
- Hiatal hernia
- Impairment to give consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Gastric Emptying Assessed by Gastric Ultrasound (US) in Healthy Volunteers and Semaglutide Users: Cohort Study
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?
Read more
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.
Read the 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.
- Conditions
- Diabetes Type 2, Obesity and Overweight
- Being tested
- Gastric Ultrasound
- Keywords
- agonist GLP-1, perioperative fasting
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric UltrasoundDiagnostic test
Also called GUS
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)
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers after high fat standardized breakfast | GUS will be made Receives: 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. Receives: Diagnostic Test: Gastric Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: 24 hours tops since the starting of the clear fluid diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start17 May 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Alemana de Santiago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javiera Vargas, Clinica Alemana de Santiago
- Investigators
- Cristian Arzola, MD, MSc, Study chair, Universidad de TorontoJuan Pablo Ghiringelli, Study director, Universidad de ValparaisoMiguel vega, MD, Study director, Universidad del Desarrollo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987669
- Sponsor's protocol ID
- ID1406
- Other IDs
- 2024-100
- Acronym
- aGLP1-GUS
- Status last verified
- Apr 2025
- First submitted
- 8 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Emptying Assessed by Gastric Ultrasound (US) in Healthy Volunteers and Semaglutide Users: Cohort Study
- ClinicalTrials.gov ID
- NCT06987669
- Acronym / sponsor ID
- aGLP1-GUS / ID1406
- Conditions
- Diabetes Type 2, Obesity and Overweight
- Keywords
- agonist GLP-1, perioperative fasting
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Clinica Alemana de SantiagoUniversity, hospital or other
- Study start
- 17 May 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers after high fat standardized breakfast | – | Diagnostic Test: Gastric UltrasoundGUS will be made |
| Patients on GLP-1 agonist | – | Diagnostic Test: Gastric UltrasoundPatients on GLP-1 agonist after clear fluids diet of 18/24 hrs. GUS will be made. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 18 years old or older
- Healthy volunteers or semaglutide users
Key exclusion criteria (3 listed)
- Bariatric surgery
- Hiatal hernia
- Impairment to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric UltrasoundAlso: GUSA 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) | Diagnostic test | Healthy volunteers after high fat standardized breakfast, Patients on GLP-1 agonist |
Primary outcome
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).
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cristian Arzola, MD, MSc study chair
Universidad de Toronto
Juan Pablo Ghiringelli study director
Universidad de Valparaiso
Miguel vega, MD study director
Universidad del Desarrollo
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Type 2 and Obesity and Overweight, run by Clinica Alemana de Santiago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Javiera Vargas, MD, MSc (+56957383772, jpvargasz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.