Gastric Volume in Patients on GLP-1 Medications

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Diabetes

Treatments: Other: None - observational

Study type: Observational

Funder types: Other

Identifiers

NCT05903482

23-021125

Details and patient eligibility

About

Evaluating gastric volume in patients on GLP-1 RA medications

Full 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.

Enrollment: 70 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Fasting Diabetic On GLP-1 RA

Exclusion criteria

Prior surgery that affects gastric anatomy

Trial design

70 participants in 3 patient groups

Diabetic, in GLP-1 RA

Description:

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

Treatment:

Other: None - observational

Diabetic, not on GLP-1 RA

Description:

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.

Treatment:

Other: None - observational

Non-diabetic, not on GLP-1 RA

Description:

non-invasive, gastric ultrasound in non-diabetic children who are not on GLP-1 RA medications and do not have diabetes or obesity.

Treatment:

Other: None - observational