Effects of GLP-1 Agonists on Gastric Volume

NCT05854979 | Completed DMC

• 1 other identifier: Pro00128783
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes; Gastric Content Aspiration; Glucagon-like Peptide 1; GLP-1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Gastric antrum CSA in RLD position

  From time of enrollment until the start of surgery, assessed up to 4 weeks

• Perlas antral grade

  From time of enrollment until the start of surgery, assessed up to 4 weeks

• Incidence of aspiration

  From the time surgery begins until the end of scheduled surgery, assessed up to 24 hours

Study Arms (2)

Diabetics taking a GLP-1 receptor agonist

Diagnostic Test: Gastric Ultrasound

Diabetics not taking a GLP-1 receptor agonist (control)

Diagnostic Test: Gastric Ultrasound

Interventions

Gastric Ultrasound DIAGNOSTIC_TEST

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.

Diabetics not taking a GLP-1 receptor agonist (control); Diabetics taking a GLP-1 receptor agonist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will consist of patients with a diagnosis of diabetes who are or are not taking a GLP-1 medication, have appropriately fasted, and scheduled for an elective surgery with general anesthesia.

You may qualify if:

• 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

You may not qualify if:

• BMI greater than 40
• Previous gastric/esophageal surgery
• Abnormal gastric anatomy
• Pregnancy
• Inability or unwillingness of subject to give informed consent
• Non-English Speaking

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Respiratory Aspiration of Gastric Contents

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Laryngopharyngeal Reflux; Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Respiratory Aspiration; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher Wolla, M.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 11, 2023
• Study Start: August 9, 2023
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

US (1)