AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingNAAges 18 Years - anyAllSt Vincent's Hospital Melbourne
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 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.
๐Ÿ’Š

What it tests

  • 24-hour clear liquid diet
  • Standard fasting guidelines
๐Ÿ“

Where

2 sites
Melbourne Gastro Oesophageal Surgery (MGOS)
Melbourne, Australia
St Vincent's Hospital Melbourne
Melbourne, Australia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy