DiabetesNCT05903482
Gastric Volume in Patients on GLP-1 Medications
An observational study of Diabetes, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Evaluating gastric volume in patients on GLP-1 RA medications Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Diabetes
- What is being tested?
- None - observational
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2023to 31 Dec 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Fasting children on GLP-1 RA
Who may be able to join
- Fasting Diabetic On GLP-1 RA
Who cannot join
- Prior surgery that affects gastric anatomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19004
About this study
Evaluating gastric volume in patients on GLP-1 RA medications
Read the detailed description
Glucagon like peptide 1 (GLP-1) receptor agonist (RA) medications have in recent years been approved for use in children with type 2 diabetes mellitis (DM) and obesity. The side effects of these medications include nausea and vomiting, and in the adult literature, delayed gastric emptying has been described. Due to the likelihood of delayed enteric motility, standard nil per os (NPO) guidelines may not be sufficient to minimize the chance of aspiration of gastric contents before anesthesia and surgery in patients receiving GLP-1 RA medications.
Investigators seek to measure the gastric volume of children on GLP-1 RA medications who are appropriately NPO (greater than/equal to 8 hours for solids and greater than/equal to 1 hour for clear liquids) using standard institutional NPO guidelines. The secondary objective is to measure the gastric volume of children not on GLP-1 RA medications, but with type 2 diabetes mellitis or obesity and/or type 1 DM.
The only study intervention is the addition of a gastric ultrasound. The gastric ultrasound is a non-invasive mode of imaging using sound waves with no known safety risks. The ultrasound will be performed while the subject is awake and will take less than 5 minutes.
- Conditions
- Diabetes
- Being tested
- None - observational
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None - observationalOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| Diabetic, in GLP-1 RA | non-invasive, gastric ultrasound in children who are on GLP-1 RA medications and have type 2 diabetes mellitis (DM) and/or obesity and/or type 1 DM Receives: Other: None - observational | |
| Diabetic, not on GLP-1 RA | non-invasive, gastric ultrasound in children who are not on GLP-1 RA medications and have type 2 diabetes mellitis (DM) and/or obesity and/or type 1 DM. Receives: Other: None - observational | |
| Non-diabetic, not on GLP-1 RA | non-invasive, gastric ultrasound in non-diabetic children who are not on GLP-1 RA medications and do not have diabetes or obesity. Receives: Other: None - observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric volume in pediatric patients on GLP-1 RA
A non-invasive, ultrasound will be performed to assess gastric volume. A second investigator not performing the ultrasound and blinded to whether the subject is taking a GLP-1 RA medication and whether the patient has diabetes and/or obesity will then assess the ultrasound images qualitatively for gastric contents (empty, clear liquids, solids) and quantitatively for gastric fluid volume if applicable.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start6 Jun 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 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 Children's Hospital of PhiladelphiaThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elaina Lin, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903482
- Sponsor's protocol ID
- 23-021125
- Status last verified
- Mar 2025
- First submitted
- 6 Jun 2023
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Volume in Patients on GLP-1 Medications
- ClinicalTrials.gov ID
- NCT05903482
- Acronym / sponsor ID
- 23-021125
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 15 Jun 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.
Evaluating gastric volume in patients on GLP-1 RA medications
Detailed description
Glucagon like peptide 1 (GLP-1) receptor agonist (RA) medications have in recent years been approved for use in children with type 2 diabetes mellitis (DM) and obesity. The side effects of these medications include nausea and vomiting, and in the adult literature, delayed gastric emptying has been described. Due to the likelihood of delayed enteric motility, standard nil per os (NPO) guidelines may not be sufficient to minimize the chance of aspiration of gastric contents before anesthesia and surgery in patients receiving GLP-1 RA medications.
Investigators seek to measure the gastric volume of children on GLP-1 RA medications who are appropriately NPO (greater than/equal to 8 hours for solids and greater than/equal to 1 hour for clear liquids) using standard institutional NPO guidelines. The secondary objective is to measure the gastric volume of children not on GLP-1 RA medications, but with type 2 diabetes mellitis or obesity and/or type 1 DM.
The only study intervention is the addition of a gastric ultrasound. The gastric ultrasound is a non-invasive mode of imaging using sound waves with no known safety risks. The ultrasound will be performed while the subject is awake and will take less than 5 minutes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diabetic, in GLP-1 RA | – | Other: None - observationalnon-invasive, gastric ultrasound in children who are on GLP-1 RA medications and have type 2 diabetes mellitis (DM) and/or obesity and/or type 1 DM |
| Diabetic, not on GLP-1 RA | – | Other: None - observationalnon-invasive, gastric ultrasound in children who are not on GLP-1 RA medications and have type 2 diabetes mellitis (DM) and/or obesity and/or type 1 DM. |
| Non-diabetic, not on GLP-1 RA | – | Other: None - observationalnon-invasive, gastric ultrasound in non-diabetic children who are not on GLP-1 RA medications and do not have diabetes or obesity. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Fasting children on GLP-1 RA
Key inclusion criteria (1 listed)
- Fasting Diabetic On GLP-1 RA
Key exclusion criteria (1 listed)
- Prior surgery that affects gastric anatomy
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 |
|---|---|---|
| None - observationalObservational | Other | Diabetic, in GLP-1 RA, Diabetic, not on GLP-1 RA, Non-diabetic, not on GLP-1 RA |
Primary outcome
Gastric volume in pediatric patients on GLP-1 RA
Time frame: Day 1
A non-invasive, ultrasound will be performed to assess gastric volume. A second investigator not performing the ultrasound and blinded to whether the subject is taking a GLP-1 RA medication and whether the patient has diabetes and/or obesity will then assess the ultrasound images qualitatively for gastric contents (empty, clear liquids, solids) and quantitatively for gastric fluid volume if applicable.
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 19 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Elaina Lin, MD principal investigator
Children's Hospital of Philadelphia
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, run by Children's Hospital of Philadelphia 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 1 inclusion and 1 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 19 Mar 2025. 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 pediatric patients on GLP-1 RA (time frame: Day 1). 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 19 Mar 2025.