Delayed Gastric EmptyingNCT06038734
Using Point-of-Care-Ultrasound (POCUS) to Assess Gastric Contents Among Fasting Pre-operative Patients Taking GLP-1 Agonists.
An observational study of Delayed Gastric Emptying and Gastroparesis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Given the increased prescription of GLP-1 agonists for both diabetes and obesity management and the implications of the proposed delayed gastric emptying in the setting of an anesthetic, it is critical to determine if patients taking GLP-1 agonists have an increased rate of delayed gastric emptying. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delayed Gastric Emptying, Gastroparesis
- What is being tested?
- gastric ultrasound
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2023to 17 Apr 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The study population will include non-critically ill adults 18 years and older undergoing various elective surgical procedures at the University of North Carolina Medical Center
Who may be able to join
- GLP-1 agonist use within previous 30 days
- Appropriately fasted per standard guidelines
Who cannot join
- History of gastric surgery / gastric volume reduction
- Critical illness
- Inability to provide informed consent
- <18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514
About this study
Given the increased prescription of GLP-1 agonists for both diabetes and obesity management and the implications of the proposed delayed gastric emptying in the setting of an anesthetic, it is critical to determine if patients taking GLP-1 agonists have an increased rate of delayed gastric emptying. The purpose of this prospective gastric ultrasound evaluation of pre-operative patients is to determine the incidence of a full stomach despite a standard pre-operative fasting period.
- Conditions
- Delayed Gastric Emptying, Gastroparesis
- Being tested
- gastric ultrasound
- Keywords
- GLP-1 agonists, retained gastric contents, glucagon-like peptide receptor-1 agonists, perioperative
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric ultrasoundDiagnostic test
Utilize POC gastric ultrasound to identify the presence of retained gastric contents.
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 agonists | Pre-operative gastric ultrasound to evaluate for retained gastric contents in appropriately fasted patients who are using GLP-1 agonist medications. Receives: Diagnostic Test: gastric ultrasound | |
| Control | Pre-operative gastric ultrasound to evaluate for retained gastric contents in appropriately fasted patients who are not using GLP-1 agonist medications. Receives: Diagnostic Test: gastric ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retained gastric contents
Presence of retained gastric contents, either liquid or solid
Measured: At time of pre-operative assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start10 Nov 2023
- Primary completion17 Apr 2024
- Study completion17 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Gastric EmptyingStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lindsey Gouker, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038734
- Sponsor's protocol ID
- 23-0578
- Status last verified
- Sep 2023
- First submitted
- 8 Sep 2023
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Point-of-Care-Ultrasound (POCUS) to Assess Gastric Contents Among Fasting Pre-operative Patients Taking GLP-1 Agonists.
- ClinicalTrials.gov ID
- NCT06038734
- Acronym / sponsor ID
- 23-0578
- Conditions
- Delayed Gastric Emptying, Gastroparesis
- Keywords
- GLP-1 agonists, retained gastric contents, glucagon-like peptide receptor-1 agonists, perioperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 15 Sep 2023 (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.
Given the increased prescription of GLP-1 agonists for both diabetes and obesity management and the implications of the proposed delayed gastric emptying in the setting of an anesthetic, it is critical to determine if patients taking GLP-1 agonists have an increased rate of delayed gastric emptying. The purpose of this prospective gastric ultrasound evaluation of pre-operative patients is to determine the incidence of a full stomach despite a standard pre-operative fasting period.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLP-1 agonists | – | Diagnostic Test: gastric ultrasoundPre-operative gastric ultrasound to evaluate for retained gastric contents in appropriately fasted patients who are using GLP-1 agonist medications. |
| Control | – | Diagnostic Test: gastric ultrasoundPre-operative gastric ultrasound to evaluate for retained gastric contents in appropriately fasted patients who are not using GLP-1 agonist medications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include non-critically ill adults 18 years and older undergoing various elective surgical procedures at the University of North Carolina Medical Center
Key inclusion criteria (2 listed)
- GLP-1 agonist use within previous 30 days
- Appropriately fasted per standard guidelines
Key exclusion criteria (4 listed)
- History of gastric surgery / gastric volume reduction
- Critical illness
- Inability to provide informed consent
- <18 years of age
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 ultrasoundUtilize POC gastric ultrasound to identify the presence of retained gastric contents. | Diagnostic test | Control, GLP-1 agonists |
Primary outcome
Retained gastric contents
Time frame: At time of pre-operative assessment
Presence of retained gastric contents, either liquid or solid
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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. This study is not recruiting at the moment.
Lindsey Gouker, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delayed Gastric Emptying and Gastroparesis, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retained gastric contents (time frame: At time of pre-operative assessment). 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 27 Jun 2024.