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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary and study completion dates: Feb 9, 2026 to Feb 1, 2027v7
  2. Eligibility criteria expanded, about 6 words
    • Secondary endpoints revised (9)
    v6
  3. Start date changed from estimate of Jun 2025 to Jun 20, 2025v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: May 12, 2025 to Jun 2025
    • Site details revised at 2 of 2 sites
    v4
  5. Eligibility criteria revised
    • Secondary endpoints: details revised at 1 of 9 entries
    v3
  6. Start date: Mar 17, 2025 to May 12, 2025
    • Study sites: 0 to 2
    • Secondary endpoints: details revised at 7 of 9 entries
    • Eligibility criteria expanded, about 3 words
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06839248
Lead Sponsor St Vincent's Hospital Melbourne
Conditions
(from sponsor)		 Residual Gastric Contents, Pulmonary Aspiration of Gastric Contents
Related terms Respiratory Aspiration of Gastric Contents
Enrollment 154 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov