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

NCT06839248 | Recruiting

• 1 other identifier: 2024/PID00396
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Residual Gastric Contents; Pulmonary Aspiration of Gastric Contents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Solid content or thick fluids

  Immediately following fasting intervention

• Thirst

  Immediately following fasting intervention

• Hunger

  Immediately following fasting intervention

• Nausea

  Immediately following fasting intervention

• Fatigue

  Immediately following fasting intervention

Study Arms (2)

24-hour clear liquid diet

EXPERIMENTAL

Other: 24-hour clear liquid diet

Standard fasting guidelines

ACTIVE COMPARATOR

Other: Standard fasting guidelines

Interventions

24-hour clear liquid diet OTHER

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.

24-hour clear liquid diet

Standard fasting guidelines OTHER

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.

Standard fasting guidelines

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St Vincent's Hospital Melbourne: lead

Study Sites (2)

Melbourne Gastro Oesophageal Surgery (MGOS)

Melbourne, Victoria, 3002, Australia

RECRUITING

St Vincent's Hospital Melbourne

Melbourne, Victoria, 3065, Australia

RECRUITING

Related Publications (10)

• 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.

  PMID: 28045707 BACKGROUND

• 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.

  PMID: 36629465 BACKGROUND

• 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.

  PMID: 25951832 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 10702749 BACKGROUND

• 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.

  PMID: 10757584 BACKGROUND

• 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.

  PMID: 8156248 BACKGROUND

• 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.

  PMID: 38039763 BACKGROUND

• 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.

  PMID: 1071419 BACKGROUND

• 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.

  PMID: 23860442 BACKGROUND

Related Links

• ANZCA PG07 Guideline on pre-anaesthesia consultation and patient preparation 2024.

MeSH Terms

Conditions

Respiratory Aspiration of Gastric Contents

Condition Hierarchy (Ancestors)

Laryngopharyngeal Reflux; Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Respiratory Aspiration; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof Michelle Dowsey, BHealthSci(Nursing), MEpi, PhD

  St Vincent's Hospital Melbourne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof Michelle Dowsey, BHealthSci(Nursing), MEpi, PhD

CONTACT

03 9231 3955; mmdowsey@unimelb.edu.au

Jasmin Elkin

CONTACT

jelkin@student.unimelb.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Arthritis Research

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 21, 2025
• Study Start: June 20, 2025
• Primary Completion: February 9, 2026
• Study Completion: February 9, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Upon request
• Access Criteria: By request, from future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed, approved by an independent committee, and can demonstrate a safe data management plan.

Locations

AU (2)