Effect of Fasting Recommendations Among Patients Using GLP-1 Receptor Agonists
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt Vincent's Hospital Melbourne
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Participant reports having been previously diagnosed with a clinically significant gastric emptying abnormality such as gastroparesis.
Trial design
Treatments tested in this trial
- 24-hour clear liquid diet
- Standard fasting guidelines
Treatment groups
154 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov