NCT06839248 Effect of Fasting Recommendations Among Patients Using GLP-1 Receptor Agonists
| NCT ID | NCT06839248 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St Vincent's Hospital Melbourne |
| Condition | Residual Gastric Contents |
| Study Type | INTERVENTIONAL |
| Enrollment | 154 participants |
| Start Date | 2025-06-20 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 154 participants in total. It began in 2025-06-20 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Prof Michelle Dowsey, BHealthSci(Nursing), MEpi, PhD
PRINCIPAL INVESTIGATOR
St Vincent's Hospital Melbourne
Frequently Asked Questions
Who can join the NCT06839248 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Residual Gastric Contents. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06839248 currently recruiting?
Yes, NCT06839248 is actively recruiting participants. Contact the research team at mmdowsey@unimelb.edu.au for enrollment information.
Where is the NCT06839248 trial being conducted?
This trial is being conducted at Melbourne, Australia, Melbourne, Australia.
Who is sponsoring the NCT06839248 clinical trial?
NCT06839248 is sponsored by St Vincent's Hospital Melbourne. The principal investigator is Prof Michelle Dowsey, BHealthSci(Nursing), MEpi, PhD at St Vincent's Hospital Melbourne. The trial plans to enroll 154 participants.