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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06839248




Registration number
NCT06839248
Ethics application status
Date submitted
11/02/2025
Date registered
21/02/2025

Titles & IDs
Public title
Effect of Fasting Recommendations Among Patients Using GLP-1 Receptor Agonists
Scientific title
Effect of Fasting Recommendations on Residual Gastric Contents Among Patients Using Glucagon-like Peptide-1 Receptor Agonists: A Randomised Controlled Trial
Secondary ID [1] 0 0
2024/PID00396
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Residual Gastric Contents 0 0
Pulmonary Aspiration of Gastric Contents 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - 24-hour clear liquid diet
Other interventions - Standard fasting guidelines

Experimental: 24-hour clear liquid diet -

Active comparator: Standard fasting guidelines -


Other interventions: 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.

Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Residual gastric contents
Timepoint [1] 0 0
Immediately following fasting intervention
Secondary outcome [1] 0 0
Solid content
Timepoint [1] 0 0
Immediately following fasting intervention
Secondary outcome [2] 0 0
Thirst
Timepoint [2] 0 0
Immediately following fasting intervention
Secondary outcome [3] 0 0
Hunger
Timepoint [3] 0 0
Immediately following fasting intervention
Secondary outcome [4] 0 0
Nausea
Timepoint [4] 0 0
Immediately following fasting intervention
Secondary outcome [5] 0 0
Fatigue
Timepoint [5] 0 0
Immediately following fasting intervention
Secondary outcome [6] 0 0
Anxiety
Timepoint [6] 0 0
Immediately following fasting intervention
Secondary outcome [7] 0 0
Adherence to intervention
Timepoint [7] 0 0
Immediately following fasting intervention
Secondary outcome [8] 0 0
Time since last oral intake of solid foods
Timepoint [8] 0 0
Immediately following fasting intervention
Secondary outcome [9] 0 0
Time since last oral intake of clear liquids
Timepoint [9] 0 0
Immediately following fasting intervention

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.
* 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
12/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/02/2026
Actual
Sample size
Target
154
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Melbourne Gastro Oesophageal Surgery (MGOS) - Melbourne
Recruitment hospital [2] 0 0
St Vincent's Hospital Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - Melbourne
Recruitment postcode(s) [2] 0 0
3065 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Hospital Melbourne
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prof Michelle Dowsey, BHealthSci(Nursing), MEpi, PhD
Address 0 0
St Vincent's Hospital Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Prof Michelle Dowsey, BHealthSci(Nursing), MEpi, PhD
Address 0 0
Country 0 0
Phone 0 0
03 9231 3955
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06839248