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

Recruiting now · Not applicable

Conditions studied: Residual Gastric Contents, Pulmonary Aspiration of Gastric Contents

In brief

The aim of this randomised controlled trial is to determine the effect of a 24-hour clear liquid diet compared to standard fasting guidelines on the proportion of participants who present with increased residual gastric contents during their study visit. It also aims to determine the effect of a 24-hour clear liquid diet compared to standard fasting guidelines on: * Solid content or thick fluids * Patient-reported outcome measures (PROMs), including thirst, hunger, nausea, fatigue, and anxiety. * Compliance measures, including adherence with the intervention, time since last oral intake of solid foods, and time since last oral intake of clear liquids. We will enrol adults who are currently using any once-weekly glucagon-like peptide-1 receptor agonist (GLP-1RA) medication. Participants will be allocated in a 1:1 ratio to follow a 24-hour clear liquid diet or standard fasting guidelines prior to attending a study visit where participants will undergo a blinded gastric ultrasound assessment.

Key facts

Study ID: NCT06839248
Run by: St Vincent's Hospital Melbourne
People needed: 154
Starts: 2025-06-20
Expected to finish: 2027-02-01
Last updated by the study team: 2026-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Melbourne Gastro Oesophageal Surgery (MGOS) — Melbourne, Victoria, Australia (enrolling)
St Vincent's Hospital Melbourne — Melbourne, Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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