Gastric Volume in Patients on GLP-1 Medications
- Conditions
- Diabetes
- Interventions
- Other: None - observational
- Registration Number
- NCT05903482
- Lead Sponsor
- Children's Hospital of Philadelphia
- Brief Summary
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Fasting Diabetic On GLP-1 RA
Prior surgery that affects gastric anatomy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Diabetic, not on GLP-1 RA None - observational 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. Diabetic, in GLP-1 RA None - observational 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 Non-diabetic, not on GLP-1 RA None - observational non-invasive, gastric ultrasound in non-diabetic children who are not on GLP-1 RA medications and do not have diabetes or obesity.
- Primary Outcome Measures
Name Time Method Gastric volume in pediatric patients on GLP-1 RA 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States