Effect of Fasting Recommendations Among Patients Using GLP-1 Receptor Agonists
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.
Study details:
GLP-1 RAs have had a transformative impact on the management of obesity, cardiovascular disease, and type 2 diabetes. Despite this, this class of medications pose a significant challenge in the perioperative setting, as GLP-1 RAs are known to increase patients' risk of presenting to surgery with residual gastric contents even when standard fasting guidance is adhered to. Such residual contents pose a risk for devastating complications if they are aspirated during surgery.
In procedures such as upper endoscopy, where clear visualisation of the gastric tract is essential, the presence of residual contents in the stomach may result in procedures being aborted, leading to patients being exposed to additional risks associated with having to repeat the procedure. Despite the urgent need for clear guidance based on reliable evidence, healthcare professionals are currently practicing in an almost complete absence of evidence regarding the management of GLP-1 RAs in the perioperative period. Our trial aims to address the uncertainty around pre-procedure management of patients using GLP-1 RAs by evaluating whether a 24-hour clear liquid diet can reduce the likelihood of increased residual gastric contents in patients using once-weekly GLP-1 RA medications, compared to the standard fasting guidelines currently recommended before elective procedures.
Standard fasting guidelines, as defined by the ASA and ANZCA, recommend clear liquids up to 2 hours before anaesthesia, a light or low calorific meal up to 6 hours before anaesthesia, and fasting from fried foods, fatty foods, or meat for at least 8 hours prior to anaesthesia. The trial will also examine the effect of this more stringent fasting guidance on outcomes including thirst, hunger, nausea, fatigue, and anxiety, which impact both comfort and satisfaction among patients undergoing surgery.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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
- 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.
- 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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
PREVENTION
Phase
- NA
Study ID
NCT06839248
Intervention or treatment
OTHER: 24-hour clear liquid diet
OTHER: Standard fasting guidelines
Conditions
- Residual Gastric Contents
- Pulmonary Aspiration of Gastric Contents
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Research sites nearby
Closest Location:
Melbourne Gastro Oesophageal Surgery (MGOS)
Select from list below to view details:
Melbourne Gastro Oesophageal Surgery (MGOS)
Melbourne, Victoria, Australia
St Vincent's Hospital Melbourne
Melbourne, Victoria, Australia
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Who is running the clinical trial?
St Vincent's Hospital Melbourne
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: 24-hour clear liquid diet
| Other: 24-hour clear liquid diet |
ACTIVE_COMPARATOR: Standard fasting guidelines
| Other: Standard fasting guidelines |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Residual gastric contents | Difference in proportion of participants who present with increased residual gastric contents, defined as \>1.5mL/kg of clear fluids, thick fluids or solids, as assessed by gastric ultrasound using the clinical algorithm by Perlas and colleagues. | Immediately following fasting intervention |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Solid content or thick fluids | Difference in proportion of participants who present with solid content or thick fluids, assessed by gastric ultrasound using the clinical algorithm by Perlas and colleagues. | Immediately following fasting intervention |
| Thirst | Mean difference in thirst, assessed using the thirst distress and thirst intensity Visual Analogue Scales. Participants rate their level of thirst distress along a scale of 0-10cm, where 10cm represents "extreme distress" and the end closest to 0cm the represents "not distressed". Participants rate their level of thirst intensity along a scale of 0-10cm, where 10cm represents "intense thirst" and the end closest to 0cm the represents "not thirsty". The average of the thirst intensity and the thirst distress score is calculated. | Immediately following fasting intervention |
| Hunger | Mean difference in hunger, assessed using the Hunger and Satiety Visual Analogue Scale. Participants rate their level of hunger along a scale of 0-10cm, where 10cm represents "I have never been more hungry, and the end closest to 0cm the represents "I am not hungry at all". | Immediately following fasting intervention |
| Nausea | Mean difference in nausea, assessed using a Visual Analogue Scale. Participants rate their level of nausea along a scale of 0-10cm, where 10cm represents "worst imaginable nausea", and the end closest to 0cm the represents "no nausea". | Immediately following fasting intervention |
| Fatigue | Mean difference in fatigue, assessed using a Visual Analogue Scale. Participants rate their level of fatigue along a scale of 0-10cm, where 10cm represents "extreme fatigue", and the end closest to 0cm the represents "not fatigued at all". | Immediately following fasting intervention |
| Anxiety | Mean difference in anxiety, assessed using the Visual Analogue Scale for Anxiety (VAS-A). Participants rate their level of anxiety along a scale of 0-10cm, where 10cm represents "most anxious I can imagine, and the end closest to 0cm the represents "not at all anxious". | Immediately following fasting intervention |
| Adherence to intervention | Difference in proportion of participants who adhere to allocated intervention, assessed using a dedicated case report form. | Immediately following fasting intervention |
| Time since last oral intake of solid foods | Mean difference in time since last oral intake of solid foods, assessed using a dedicated case report form. | Immediately following fasting intervention |
| Time since last oral intake of clear liquids | Mean difference in time since last oral intake of clear liquids, assessed using a dedicated case report form. | Immediately following fasting intervention |
References
Clinical Trials Gov: Effect of Fasting Recommendations Among Patients Using GLP-1 Receptor AgonistsOther trials to consider
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