Gastric Volume in Patients on GLP-1 Medications

NCT ID: NCT05903482

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-06

Study Completion Date

2024-12-31

Brief Summary

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Evaluating gastric volume in patients on GLP-1 RA medications

Detailed Description

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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

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Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

None - observational

Intervention Type OTHER

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.

None - observational

Intervention Type OTHER

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.

None - observational

Intervention Type OTHER

Observational

Interventions

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None - observational

Observational

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Fasting Diabetic On GLP-1 RA

Exclusion Criteria

Prior surgery that affects gastric anatomy
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elaina Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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23-021125

Identifier Type: -

Identifier Source: org_study_id

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