Effect of Fasting Recommendations Among Patients Using GLP-1 Receptor Agonists
NCT ID: NCT06839248
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
154 participants
INTERVENTIONAL
2025-06-20
2026-02-09
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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24-hour clear liquid diet
24-hour clear liquid diet
Participants randomly assigned to this arm will be instructed to follow a 24-hour clear liquid diet, defined as NPO for solids and last intake of clear liquids no less than 2 hours prior to the trial visit.
Standard fasting guidelines
Standard fasting guidelines
Participants randomly assigned to this arm will be instructed to follow the ASA and ANZCA standards for preoperative fasting prior to presenting for their trial visit. 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.
Interventions
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24-hour clear liquid diet
Participants randomly assigned to this arm will be instructed to follow a 24-hour clear liquid diet, defined as NPO for solids and last intake of clear liquids no less than 2 hours prior to the trial visit.
Standard fasting guidelines
Participants randomly assigned to this arm will be instructed to follow the ASA and ANZCA standards for preoperative fasting prior to presenting for their trial visit. 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.
Eligibility Criteria
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Inclusion Criteria
* 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.
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.
18 Years
ALL
No
Sponsors
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St Vincent's Hospital Melbourne
OTHER
Responsible Party
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Prof. Michelle Dowsey
Head Arthritis Research
Principal Investigators
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Prof Michelle Dowsey, BHealthSci(Nursing), MEpi, PhD
Role: PRINCIPAL_INVESTIGATOR
St Vincent's Hospital Melbourne
Locations
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Melbourne Gastro Oesophageal Surgery (MGOS)
Melbourne, Victoria, Australia
St Vincent's Hospital Melbourne
Melbourne, Victoria, Australia
Countries
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Central Contacts
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Prof Michelle Dowsey, BHealthSci(Nursing), MEpi, PhD
Role: CONTACT
Facility Contacts
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References
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Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
Joshi GP, Abdelmalak BB, Weigel WA, Harbell MW, Kuo CI, Soriano SG, Stricker PA, Tipton T, Grant MD, Marbella AM, Agarkar M, Blanck JF, Domino KB. 2023 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting: Carbohydrate-containing Clear Liquids with or without Protein, Chewing Gum, and Pediatric Fasting Duration-A Modular Update of the 2017 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting. Anesthesiology. 2023 Feb 1;138(2):132-151. doi: 10.1097/ALN.0000000000004381.
Perlas A, Van de Putte P, Van Houwe P, Chan VW. I-AIM framework for point-of-care gastric ultrasound. Br J Anaesth. 2016 Jan;116(1):7-11. doi: 10.1093/bja/aev113. Epub 2015 May 7. No abstract available.
Carey S, Waller J, Wang LY, Ferrie S. Qualifying thirst distress in the acute hospital setting-validation of a patient-reported outcome measure. Journal of Perioperative Nursing.2021;34(4):e38-e44.
Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab Disord. 2000 Jan;24(1):38-48. doi: 10.1038/sj.ijo.0801083.
Boogaerts JG, Vanacker E, Seidel L, Albert A, Bardiau FM. Assessment of postoperative nausea using a visual analogue scale. Acta Anaesthesiol Scand. 2000 Apr;44(4):470-4. doi: 10.1034/j.1399-6576.2000.440420.x.
Glaus A. Assessment of fatigue in cancer and non-cancer patients and in healthy individuals. Support Care Cancer. 1993 Nov;1(6):305-15. doi: 10.1007/BF00364968.
Desrame J, Baize N, Anota A, Laribi K, Stefani L, Hjiej S, Nabirotchkina E, Zelek L, Choquet S. Fatigue visual analogue scale score correlates with quality of life in cancer patients receiving epoetin alfa (Sandoz) for chemotherapy-induced anaemia: The CIROCO study. Cancer Treat Res Commun. 2023;37:100781. doi: 10.1016/j.ctarc.2023.100781. Epub 2023 Nov 23.
Hornblow AR, Kidson MA. The visual analogue scale for anxiety: a validation study. Aust N Z J Psychiatry. 1976 Dec;10(4):339-41. doi: 10.3109/00048677609159523. No abstract available.
Facco E, Stellini E, Bacci C, Manani G, Pavan C, Cavallin F, Zanette G. Validation of visual analogue scale for anxiety (VAS-A) in preanesthesia evaluation. Minerva Anestesiol. 2013 Dec;79(12):1389-95. Epub 2013 Jul 9.
Related Links
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ANZCA PG07 Guideline on pre-anaesthesia consultation and patient preparation 2024.
Other Identifiers
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2024/PID00396
Identifier Type: -
Identifier Source: org_study_id
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