RecruitingPhase NA

Effect of Fasting Recommendations Among Patients Using GLP-1 Receptor Agonists

Effect of Fasting Recommendations on Residual Gastric Contents Among Patients Using Glucagon-like Peptide-1 Receptor Agonists: A Randomised Controlled Trial

Lead sponsor

St Vincent's Hospital Melbourne

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Estimated enrollment

154

Study population

Eligibility highlights

Primary endpoint

•Residual gastric contents

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06839248

Org study ID2024/PID00396

Timeline

Milestones

Study first posted2025-02-21actual

Study start2025-06-20actual

Last update posted2026-05-11actual

Primary completion2027-02-01estimated

Study completion2027-02-01estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age ≥18 years old at enrolment.

•Have regularly administered any type of once-weekly GLP-1 RA medication for a period of at least one month prior to randomisation.

•If allocated to follow standard fasting guidelines, willing to adhere to ASA and ANZCA preoperative fasting requirements. This requires participants to only consume clear liquids up to 2 hours, a light or low calorific meal up to 6 hours, and fasting from fried foods, fatty foods, or meat for at least 8 hours prior to the trial visit.

•If allocated to follow a 24-hour clear liquid diet, willing to adhere to nothing-by-mouth (NPO) for solids and last intake of clear liquids no less than 2 hours prior to the trial visit.

•Provide a signed and dated informed consent form for study participation in line with the requirements of the human research ethics committee (HREC) of the study site.

Exclusion criteria

Participants meeting any of the following criteria, indicative of abnormal anatomy and not validated by gastric ultrasound, will be excluded from this trial:

•Has a recent history of gastrointestinal bleed within the previous 1 month from enrolment.

•Has a history of previous lower oesophageal or gastric surgery.

•Has a known abnormal upper gastrointestinal anatomy, including hiatus hernia or gastric tumours.

In addition, participants meeting any the of following criteria will be excluded from this trial:

•Participant reports having been previously diagnosed with a clinically significant gastric emptying abnormality such as gastroparesis.

•Participant reports concomitant use of insulin.

•Unable to assume the right lateral decubitus position required for gastric ultrasound assessment.

•Participant has difficulty fully understanding PICF or study materials due to a primary language other than English.

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

Other clinical outcomes