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New treatment option for Residual Gastric Contents
Official title Effect of Fasting Recommendations Among Patients Using GLP-1 Receptor Agonists
ClinicalTrials.gov ID: NCT06839248
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
- Provide a signed and dated informed consent form for study participation in line with the requirements of the human research ethics committee (HREC)...
You likely can't join if
- Participants meeting any of the following criteria, indicative of abnormal anatomy and not validated by gastric ultrasound, will be excluded from...
- 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...
- Participant reports having been previously diagnosed with a clinically significant gastric emptying abnormality such as gastroparesis.
- Participant reports concomitant use of insulin.
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.