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NCT Number: NCT05854979

Effects of GLP-1 Agonists on Gastric Volume

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.

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Key information

Conditions

Diabetes Deglutition Disorders Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Esophageal Diseases Esophageal Motility Disorders GLP-1 Gastric Content Aspiration Gastroesophageal Reflux Gastrointestinal Diseases Glucagon-like Peptide 1 Glucose Metabolism Disorders Laryngopharyngeal Reflux Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Aspiration of Gastric Contents Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Gastric antrum CSA in RLD position

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

  2. Perlas antral grade

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

  3. Incidence of aspiration

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

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 11, 2023
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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