DiabetesNCT05854979
Effects of GLP-1 Agonists on Gastric Volume
An observational study of Diabetes and Gastric Content Aspiration, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study will enroll patients ages 18 and over who have a diagnosis of diabetes, are undergoing an elective surgery under general anesthesia and 1) are taking a GLP-1 receptor agonist medication, or 2) not taking a GLP-1 receptor agonist medication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Gastric Content Aspiration, Glucagon-like Peptide 1
- What is being tested?
- Gastric Ultrasound
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2023to 15 Apr 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: This study will consist of patients with a diagnosis of diabetes who are or are not taking a GLP-1 medication, have appropriately fasted, and scheduled for an elective surgery with general anesthesia.
Who may be able to join
- Age greater than or equal to 18 years old
- Diagnosed with diabetes (listed on medical record, Hgb A1C greater than or equal to 6.5%, fasting blood glucose greater than or equal to 126mg/dL, and/or on medical treatment for diabetes)
- One of the following groups:
- Taking a GLP-1 Medication
- Not taking a GLP-1 Medication
- ASA Physical Classification Status 1-3
- Scheduled for elective surgery under general anesthesia
- Appropriately fasted per ASA Fasting Guidelines 201712
Who cannot join
- BMI greater than 40
- Previous gastric/esophageal surgery
- Abnormal gastric anatomy
- Pregnancy
- Inability or unwillingness of subject to give informed consent
- Non-English Speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Ultrasound Assessment of Preoperative Gastric Volume in Fasted, Diabetic Surgical Patients: A Prospective Observational Cohort Study on the Effects of GLP-1 Agonists on Gastric Emptying
This study will enroll patients ages 18 and over who have a diagnosis of diabetes, are undergoing an elective surgery under general anesthesia and 1) are taking a GLP-1 receptor agonist medication, or 2) not taking a GLP-1 receptor agonist medication. The patients will have a gastric ultrasound prior to surgery to measure any retained gastric contents. The primary goal is to assess the effect of subcutaneous injectable GLP-1 agonists on preoperative gastric volume in fasted, diabetic surgical patients.
- Conditions
- Diabetes, Gastric Content Aspiration, Glucagon-like Peptide 1, GLP-1
- Being tested
- Gastric Ultrasound
- Medical subject headings
- Diabetes Mellitus, Respiratory Aspiration of Gastric Contents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric UltrasoundDiagnostic test
A gastric ultrasound will be completed on every patient and administered the same way in each arm. The patient will be placed in supine position. A curvilinear ultrasound probe will be placed on the sagittal plane below the xiphoid process. The probe will then slide along the costal margin to the right until the gastric antrum is identified. At this point, the ultrasound image will be obtained, and appropriate measurements will be taken. The patient will be placed in the right lateral decubitus position and the above procedure will be repeated.
| Study group | Role | What they receive |
|---|---|---|
| Diabetics taking a GLP-1 receptor agonist | Not described Receives: Diagnostic Test: Gastric Ultrasound | |
| Diabetics not taking a GLP-1 receptor agonist (control) | Not described Receives: Diagnostic Test: Gastric Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric Volume in RLD Position
The gastric volume will be calculated using a validated formula.
Measured: From time of enrollment until the start of surgery, assessed up to 4 weeks
Secondary outcomes (3)
Gastric antrum CSA in RLD position
Measured: From time of enrollment until the start of surgery, assessed up to 4 weeks
Perlas antral grade
Measured: From time of enrollment until the start of surgery, assessed up to 4 weeks
Incidence of aspiration
Measured: From the time surgery begins until the end of scheduled surgery, assessed up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start9 Aug 2023
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Wolla, Medical University of South Carolina
- Investigators
- Christopher Wolla, M.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854979
- Sponsor's protocol ID
- Pro00128783
- Status last verified
- Apr 2024
- First submitted
- 2 May 2023
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Preoperative Gastric Volume in Fasted, Diabetic Surgical Patients: A Prospective Observational Cohort Study on the Effects of GLP-1 Agonists on Gastric Emptying
- ClinicalTrials.gov ID
- NCT05854979
- Acronym / sponsor ID
- Pro00128783
- Conditions
- Diabetes, Gastric Content Aspiration, Glucagon-like Peptide 1, GLP-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 11 May 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.
This study will enroll patients ages 18 and over who have a diagnosis of diabetes, are undergoing an elective surgery under general anesthesia and 1) are taking a GLP-1 receptor agonist medication, or 2) not taking a GLP-1 receptor agonist medication. The patients will have a gastric ultrasound prior to surgery to measure any retained gastric contents. The primary goal is to assess the effect of subcutaneous injectable GLP-1 agonists on preoperative gastric volume in fasted, diabetic surgical patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetics taking a GLP-1 receptor agonist | – | Diagnostic Test: Gastric Ultrasound |
| Diabetics not taking a GLP-1 receptor agonist (control) | – | Diagnostic Test: Gastric Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will consist of patients with a diagnosis of diabetes who are or are not taking a GLP-1 medication, have appropriately fasted, and scheduled for an elective surgery with general anesthesia.
Key inclusion criteria (8 listed)
- Age greater than or equal to 18 years old
- Diagnosed with diabetes (listed on medical record, Hgb A1C greater than or equal to 6.5%, fasting blood glucose greater than or equal to 126mg/dL, and/or on medical treatment for diabetes)
- One of the following groups:
- Taking a GLP-1 Medication
- Not taking a GLP-1 Medication
Key exclusion criteria (6 listed)
- BMI greater than 40
- Previous gastric/esophageal surgery
- Abnormal gastric anatomy
- Pregnancy
- Inability or unwillingness of subject to give informed 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 UltrasoundA gastric ultrasound will be completed on every patient and administered the same way in each arm. The patient will be placed in supine position. A curvilinear ultrasound probe will be placed on the sagittal plane below the xiphoid process. The probe will then slide along the costal margin to the right until the gastric antrum is identified. At this point, the ultrasound image will be obtained, and appropriate measurements will be taken. The patient will be placed in the right lateral decubitus position and the above procedure will be repeated. | Diagnostic test | Diabetics not taking a GLP-1 receptor agonist (control), Diabetics taking a GLP-1 receptor agonist |
Primary outcome
Gastric Volume in RLD Position
Time frame: From time of enrollment until the start of surgery, assessed up to 4 weeks
The gastric volume will be calculated using a validated formula.
3 secondary outcomes
Gastric antrum CSA in RLD position
Time frame: From time of enrollment until the start of surgery, assessed up to 4 weeks
Perlas antral grade
Time frame: From time of enrollment until the start of surgery, assessed up to 4 weeks
Incidence of aspiration
Time frame: From the time surgery begins until the end of scheduled surgery, assessed up to 24 hours
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 25 Apr 2024.
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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.
Christopher Wolla, M.D. principal investigator
Medical University of South Carolina
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 Diabetes and Gastric Content Aspiration, run by Medical University of South Carolina 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 8 inclusion and 6 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 25 Apr 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?
Gastric Volume in RLD Position (time frame: From time of enrollment until the start of surgery, assessed up to 4 weeks). 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 25 Apr 2024.