Effects of GLP-1 Agonists on Gastric Volume

April 23, 2024 updated by: Christopher Wolla, Medical University of South Carolina

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diabetics taking a GLP-1 receptor agonist
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.
Diabetics not taking a GLP-1 receptor agonist (control)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric Volume in RLD Position
Time Frame: From time of enrollment until the start of surgery, assessed up to 4 weeks
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 Outcome Measures

Outcome Measure
Time Frame
Gastric antrum CSA in RLD position
Time Frame: From time of enrollment until the start of surgery, assessed up to 4 weeks
From time of enrollment until the start of surgery, assessed up to 4 weeks
Perlas antral grade
Time Frame: From time of enrollment until the start of surgery, assessed up to 4 weeks
From time of enrollment until the start of surgery, assessed up to 4 weeks
Incidence of aspiration
Time Frame: From the time surgery begins until the end of scheduled surgery, assessed up to 24 hours
From the time surgery begins until the end of scheduled surgery, assessed up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: Christopher Wolla, M.D., Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2023

Primary Completion (Actual)

April 15, 2024

Study Completion (Actual)

April 15, 2024

Study Registration Dates

First Submitted

May 2, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Actual)

May 11, 2023

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00128783

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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