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GLP1 Fasting Status and Gastric Retention Using Gastric Ultrasound 150 Dietary

Recruiting
Clinical Trial NCT07251803 is an observational study for Gastric Retention that is recruiting. It started on February 3, 2026 with plans to enroll 150 participants. Led by Medical University of South Carolina, it is expected to complete by December 31, 2026. The latest data from ClinicalTrials.gov was last updated on February 25, 2026.
Brief Summary
This study will enroll patients 18 years and older who are taking a GLP-1/GIP medication and 1) are scheduled for elective surgery and meet ASA fasting guidelines (nothing by mouth for at least 8 hours prior), or 2) scheduled elective colonoscopy and have been on a clear liquid diet for at least 24 hours prior. Participants will have a gastric ultrasound prior to surgery to measure any retained gastric contents. The ...Show More
Detailed Description
Patients will be classified into one of two groups:

  1. Taking a GLP-1/GLP-GIP medication and undergoing an elective colonoscopy and have been on a clear liquid diet for the past 24-hours.

    or

  2. Taking a GLP-1/GLP-GIP medication and undergoing am elective surgery and have fasted appropriately according to ASA guidelines.

All participants will undergo a gastric ultrasound in the preoperative area prior to their s...

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Official Title

An Observational Study to Examine Non-inferiority of the Standard ASA Fasting Guidelines Versus 24-hour Clear Liquid Diet for Gastric Volume in Patients Taking GLP-1 Agonists

Conditions
Gastric Retention
Other Study IDs
  • Pro00147318
NCT ID Number
NCT07251803
Start Date (Actual)
2026-02-03
Last Update Posted
2026-02-25
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
150
Study Type
Observational
Status
Recruiting
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ASA fasting guidelines
Scheduled elective surgery and meet ASA fasting guidelines (NPO for at least 8 hours prior)
Gastric Ultrasound
All participants will undergo a gastric ultrasound in the preoperative area prior to their scheduled procedure. 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 appro...Show More
24-hour clear liquid diet
Scheduled elective colonoscopy and have been on a clear liquid diet for at least 24 hours prior
Gastric Ultrasound
All participants will undergo a gastric ultrasound in the preoperative area prior to their scheduled procedure. 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 appro...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Pre-operative gastric volume per unit of weight (ml/kg) as assessed by gastric ultrasound.
While the patient is in supine position, the gastric volume will be measured via ultrasound and then calculated using a validated formula, GV (mL) = 27.0+(14.6\*CSA)-(1.28\*age).
From enrollment until completion of pre-operative gastric ultrasound (typically within 3 hours of scheduled procedure).
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Perlas antral grade
Qualitative grading of the appearance of the gastric antrum in right lateral decubitus (RLD) will be graded as follows:1 * Grade 0 antrum appears empty in both positions, and suggests no gastric content is present. * Grade 1 antrum appears empty in the supine position, but clear fluid is visible in the RLD, consistent with a small volume of gastric fluid. * Grade 2 antrum is that in which clear fluid is evident in both patient positions, or any solids in any position which is consistent with a higher volume state.
From enrollment until completion of gastric ultrasound (within 3 hours of scheduled procedure).
Incidence of full stomach on gastric ultrasound assessment
Incidence of full stomach defined as solid or thick liquids on US or \>1.5mL/kg of clear liquid upon gastric ultrasound.
From time of enrollment until the start of surgery, up to 24 hours.
Incidence of regurgitation under anesthesia
From induction of anesthesia until end of surgery (up to 8 hours).
Incidence of change in anesthetic management based on stomach contents
Assessed at enrollment and during gastric ultrasound (within 3 hours of scheduled procedure).
Differences in "high risk GLP-1" vs "low risk GLP-1"
High Risk includes: * Escalation Phase: increase in dose within the past 30 days * High Dose * Weekly Dosing * Presence of severe GI symptoms such as nausea, vomiting, or retching, abdominal bloating, or abdominal pain with GLP-1 administration Low dose and high dose are classified as: Oral Semaglutide (Rybelsus) Low dose: \< 5 mg High dose: \> 5 mg Tirzepatide (Mounjaro and Zepbound) Low dose: 2.5, 5, and 7.5 mg High dose: 10, 12.5, 15 mg SubQ Semaglutide (Ozempic and Wegovy) Low dose: 0.25 and 0.5 mg High dose: 1 and 2 mg Dulaglutide (Trulicity) Low dose: 0.75 and 1.5 mg High dose: 3.0 and 4.5 mg Liraglutide (Victoza) Low dose: 0.6 mg High dose: 1.2 and 1.8 mg Exenatide (Byetta) Low dose: 5 mcg High dose: 10 mcg
assessed at time of enrollment from the past 30 days until completion of gastric ultrasound
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  • Age 18+

  • Have taken a GLP-1 or GLP-GIP agonist medication within the past 30 days

  • ASA Physical Classification Status 1-3

  • Fall into one of the following groups:

    1. Scheduled elective surgery and meet ASA fasting guidelines (NPO for at least 8 hours prior)
    2. Scheduled elective colonoscopy and have been on a clear liquid diet for at least 24 hours prior

  • Previous gastric or esophageal surgery
  • Abnormal gastric anatomy
  • Pregnancy
  • Unable to provide written, informed consent
  • Non-English speaking
Medical University of South Carolina logoMedical University of South Carolina249 active studies to explore
Study Responsible Party
Christopher Wolla, Principal Investigator, Assistant Professor-Faculty, Medical University of South Carolina
Study Central Contact
Contact: Haley Nitchie, MHA, 843-792-1869, [email protected]
1 Study Locations in 1 Countries

South Carolina

Medical University of South Carolina, Charleston, South Carolina, 29425, United States
Haley Nitchie, MHA, Contact, 843-792-1869, [email protected]
Christopher Wolla, M.D., Principal Investigator
Recruiting