Effects of GLP-1 Agonists on Gastric Volume

Diabetes Clinical Trial

Official title:

Ultrasound Assessment of Preoperative Gastric Volume in Fasted, Diabetic Surgical Patients: A Prospective Observational Cohort Study on the Effects of GLP-1 Agonists on Gastric Emptying

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05854979
• Other study ID #: Pro00128783
• Status: Completed
• Start date: August 9, 2023
• Est. completion date: April 15, 2024

Study information

• Verified date: April 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will enroll patients ages 18 and over who have a diagnosis of diabetes, are undergoing an elective surgery under general anesthesia and 1) are taking a GLP-1 receptor agonist medication, or 2) not taking a GLP-1 receptor agonist medication. The patients will have a gastric ultrasound prior to surgery to measure any retained gastric contents. The primary goal is to assess the effect of subcutaneous injectable GLP-1 agonists on preoperative gastric volume in fasted, diabetic surgical patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: April 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Age greater than or equal to 18 years old

• Diagnosed with diabetes (listed on medical record, Hgb A1C greater than or equal to 6.5%, fasting blood glucose greater than or equal to 126mg/dL, and/or on medical treatment for diabetes)

• One of the following groups:

• Taking a GLP-1 Medication

• Not taking a GLP-1 Medication

• ASA Physical Classification Status 1-3

• Scheduled for elective surgery under general anesthesia

• Appropriately fasted per ASA Fasting Guidelines 201712

Exclusion Criteria

• BMI greater than 40

• Previous gastric/esophageal surgery

• Abnormal gastric anatomy

• Pregnancy

• Inability or unwillingness of subject to give informed consent

• Non-English Speaking

Related Conditions & MeSH terms

• Diabetes
• Glucagon-like Peptide 1
• Respiratory Aspiration of Gastric Contents

Intervention

Diagnostic Test:
• Gastric Ultrasound
A gastric ultrasound will be completed on every patient and administered the same way in each arm. The patient will be placed in supine position. A curvilinear ultrasound probe will be placed on the sagittal plane below the xiphoid process. The probe will then slide along the costal margin to the right until the gastric antrum is identified. At this point, the ultrasound image will be obtained, and appropriate measurements will be taken. The patient will be placed in the right lateral decubitus position and the above procedure will be repeated.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric Volume in RLD Position	The gastric volume will be calculated using a validated formula.	From time of enrollment until the start of surgery, assessed up to 4 weeks
Secondary	Gastric antrum CSA in RLD position		From time of enrollment until the start of surgery, assessed up to 4 weeks
Secondary	Perlas antral grade		From time of enrollment until the start of surgery, assessed up to 4 weeks
Secondary	Incidence of aspiration		From the time surgery begins until the end of scheduled surgery, assessed up to 24 hours