GLP_1 RA Ultrasound Study

• Conditions: Glucagon Like Peptide-1 (GLP-1; Delayed Gastric Emptying; Risk of Aspiration; Diabetes; Morbid Obesity
• Interventions: Drug: Glucagon-Like Peptide-1 receptor agonists; Diagnostic Test: Point of Care Gastric Ultrasound

• Registration Number: NCT06581120
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-08
• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-29
• Study First Posted: 2024-09-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-07
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GLP-1	Glucagon-Like Peptide-1 receptor agonists	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.
GLP-1	Point of Care Gastric Ultrasound	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.
Control	Point of Care Gastric Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Aspiration Risk determined by POGUS	Two years	Difference between control group and GLP-1 group. Measured by Gastric contents during Point of Care Gastric Ultrasound.

Trial Locations

Locations (1)

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States