Glucagon Like Peptide-1 (GLP-1NCT06581120
GLP_1 RA Ultrasound Study
An observational study of Glucagon Like Peptide-1 (GLP-1 and Delayed Gastric Emptying, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of the study is to determine whether patients taking GLP-1 RAs have increased residual (left behind), gastric (stomach), contents due to delayed gastric emptying when following standard preoperative fasting guidelines. Read more about this study
- Who is it for?
- Ages 10 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucagon Like Peptide-1 (GLP-1, Delayed Gastric Emptying, Risk of Aspiration
- What is being tested?
- Glucagon-Like Peptide-1 receptor agonists and Point of Care Gastric Ultrasound
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2024to Jul 2026
- 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 10 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Subjects will be recruited from the endocrine clinic and from the preoperative surgical schedule.
Who may be able to join
- Body Mass Index over 35
- Type 2 Diabetes
- Currently taking GLP01 RA agonist (for GLP 1 group)
- Not taking GLP-1 RA agonist (for control group)
Who cannot join
- Diagnosis of gastroparesis
- patient refusal to participate
- Previous gastric bypass or any other gastric surgery
- Currently on peritoneal dialysis
- Abdominal pathology
- Gastro-intestinal obstruction
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cincinnati Children's Hospital
Cincinnati, Ohio, 45299
About this study
Official title: Assessment of Gastric Contents in Patients Taking Glucagon-Like Peptide-1 Receptor Agonists: a Prospective Observational Cross-sectional Study
The purpose of the study is to determine whether patients taking GLP-1 RAs have increased residual (left behind), gastric (stomach), contents due to delayed gastric emptying when following standard preoperative fasting guidelines.
- Conditions
- Glucagon Like Peptide-1 (GLP-1, Delayed Gastric Emptying, Risk of Aspiration, Diabetes, Morbid Obesity
- Being tested
- Glucagon-Like Peptide-1 receptor agonists, Point of Care Gastric Ultrasound
- Keywords
- GLP-1, Glucagon like Peptide 1, Aspiration, Gastric empty
- Medical subject headings
- Gastroparesis, Diabetes Mellitus, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucagon-Like Peptide-1 receptor agonistsDrug
GLP-1 RAs: Glucagon like peptide-1 receptor agonists, this includes patients who are on Liraglutide, Semaglutide, Dulaglutide and Tirzepatide.Tirzepatide which is a combined GLP-1 RA/glucose-dependent insulinotropic polypeptide (GIP) agonist is included as a part of GLP-1 RAs.
Point of Care Gastric UltrasoundDiagnostic test
Also called POGUS
A gastric ultrasound following a standard NPO period to determine gastric contents and risk of aspiration during surgery.
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 | Individuals currently taking glucagon like peptide receptors who have a surgery scheduled with Cincinnati Children's Hospital same day surgery endocrinology clinic and will receive a point of care gastric ultrasound. Receives: Drug: Glucagon-Like Peptide-1 receptor agonists; Diagnostic Test: Point of Care Gastric Ultrasound | |
| Control | Individuals not taking GLP-1 who have a surgery scheduled with Cincinnati Children's Hospital same day surgery or endocrinology clinic and will receive a point of care gastric ultrasound. Receives: Diagnostic Test: Point of Care Gastric Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aspiration Risk determined by POGUS
Difference between control group and GLP-1 group. Measured by Gastric contents during Point of Care Gastric Ultrasound.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start8 Jul 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucagon Like Peptide-1 (GLP-1Studies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581120
- Sponsor's protocol ID
- 2024-0304
- Status last verified
- Nov 2024
- First submitted
- 27 Aug 2024
- Last updated
- 7 Nov 2024
- 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 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Gastric Contents in Patients Taking Glucagon-Like Peptide-1 Receptor Agonists: a Prospective Observational Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06581120
- Acronym / sponsor ID
- 2024-0304
- Conditions
- Glucagon Like Peptide-1 (GLP-1, Delayed Gastric Emptying, Risk of Aspiration, Diabetes, Morbid Obesity
- Keywords
- GLP-1, Glucagon like Peptide 1, Aspiration, Gastric empty
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 3 Sep 2024 (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.
The purpose of the study is to determine whether patients taking GLP-1 RAs have increased residual (left behind), gastric (stomach), contents due to delayed gastric emptying when following standard preoperative fasting guidelines.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLP-1 | – | Drug: Glucagon-Like Peptide-1 receptor agonists, Diagnostic Test: Point of Care Gastric UltrasoundIndividuals currently taking glucagon like peptide receptors who have a surgery scheduled with Cincinnati Children's Hospital same day surgery endocrinology clinic and will receive a point of care gastric ultrasound. |
| Control | – | Diagnostic Test: Point of Care Gastric UltrasoundIndividuals not taking GLP-1 who have a surgery scheduled with Cincinnati Children's Hospital same day surgery or endocrinology clinic and will receive a point of care gastric ultrasound. |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Subjects will be recruited from the endocrine clinic and from the preoperative surgical schedule.
Key inclusion criteria (4 listed)
- Body Mass Index over 35
- Type 2 Diabetes
- Currently taking GLP01 RA agonist (for GLP 1 group)
- Not taking GLP-1 RA agonist (for control group)
Key exclusion criteria (7 listed)
- Diagnosis of gastroparesis
- patient refusal to participate
- Previous gastric bypass or any other gastric surgery
- Currently on peritoneal dialysis
- Abdominal pathology
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 |
|---|---|---|
| Glucagon-Like Peptide-1 receptor agonistsGLP-1 RAs: Glucagon like peptide-1 receptor agonists, this includes patients who are on Liraglutide, Semaglutide, Dulaglutide and Tirzepatide.Tirzepatide which is a combined GLP-1 RA/glucose-dependent insulinotropic polypeptide (GIP) agonist is included as a part of GLP-1 RAs. | Drug | GLP-1 |
| Point of Care Gastric UltrasoundAlso: POGUSA gastric ultrasound following a standard NPO period to determine gastric contents and risk of aspiration during surgery. | Diagnostic test | Control, GLP-1 |
Primary outcome
Aspiration Risk determined by POGUS
Time frame: Two years
Difference between control group and GLP-1 group. Measured by Gastric contents during Point of Care Gastric Ultrasound.
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 7 Nov 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Glucagon Like Peptide-1 (GLP-1 and Delayed Gastric Emptying, run by Children's Hospital Medical Center, Cincinnati 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 4 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 7 Nov 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?
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?
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?
Aspiration Risk determined by POGUS (time frame: Two years). 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 7 Nov 2024.