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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06500130
Registration number
NCT06500130
Ethics application status
Date submitted
8/07/2024
Date registered
15/07/2024
Date last updated
25/03/2025
Titles & IDs
Public title
Effects of Liraglutide on Body Surface Gastric Mapping
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Scientific title
Effects of Liraglutide on Body Surface Gastric Mapping
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Secondary ID [1]
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2024 FULL 19945
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastroparesis
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Functional Dyspepsia
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Chronic Nausea and Vomiting Syndrome
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Healthy
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Body Surface Gastric Mapping
Experimental: Liraglutide Group - All study participants will be in this group and will have a total of three body surface gastric mapping tests conducted, pre, during and post liraglutide intervention.
Treatment: Devices: Body Surface Gastric Mapping
All study participants will be in this group and will have a total of three body surface gastric mapping tests conducted, pre, during and post liraglutide.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in overall postprandial BSGM Gastric Alimetry Rhythm Index (GA-RI) on treatment compared to baseline.
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Assessment method [1]
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Change in overall postprandial BSGM Gastric Alimetry Rhythm Index (GA-RI) on treatment compared to baseline.
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Timepoint [1]
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2 weeks
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Secondary outcome [1]
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Change in the following symptoms on treatment compared to baseline
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Assessment method [1]
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GCSI-DD (3 day average, last 3 days on treatment vs 3 days baseline) Alimetry total symptom burden Alimetry individual symptoms
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Timepoint [1]
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2 weeks
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Secondary outcome [2]
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Change in overall postprandial BMI-adjusted amplitude on treatment compared to baseline
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Assessment method [2]
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Change in overall postprandial BMI-adjusted amplitude on treatment compared to baseline
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Timepoint [2]
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2 weeks
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Secondary outcome [3]
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Change in GA-RI on treatment to washout
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Assessment method [3]
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Change in GA-RI on treatment to washout
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Timepoint [3]
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1 week
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Secondary outcome [4]
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Change in BMI-adjusted amplitude on treatment to washout
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Assessment method [4]
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Change in BMI-adjusted amplitude on treatment to washout
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Timepoint [4]
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1 week
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Secondary outcome [5]
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Correlation of total symptom burden with change in GA-RI
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Assessment method [5]
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Correlation of total symptom burden with change in GA-RI
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Timepoint [5]
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4 weeks
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Secondary outcome [6]
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Correlation of total symptom burden with change in BMI-adjusted amplitude
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Assessment method [6]
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Correlation of total symptom burden with change in BMI-adjusted amplitude
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Timepoint [6]
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4 weeks
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Secondary outcome [7]
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Change in gastric emptying half-time on treatment compared to baseline
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Assessment method [7]
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Change in gastric emptying half-time on treatment compared to baseline
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Timepoint [7]
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2 weeks
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Secondary outcome [8]
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Correlation of gastric emptying half-time with GA-RI on treatment
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Assessment method [8]
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Correlation of gastric emptying half-time with GA-RI on treatment
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Timepoint [8]
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2 weeks
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Secondary outcome [9]
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Correlation of gastric emptying half-time with total symptom burden on treatment
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Assessment method [9]
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Correlation of gastric emptying half-time with total symptom burden on treatment
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Timepoint [9]
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2 weeks
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Eligibility
Key inclusion criteria
* Provision of signed and dated informed consent form, AND
* Aged between 18 and 65 years old, AND
* Healthy volunteer with no previous history of gastrointestinal disorders/symptoms
* BMI 22-35
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Confirmed diagnosis of a comorbidity known to affect gastric motility (i.e., Parkinson's Disease, Type 1 or 2 Diabetes).
2. Medications in the last 3 months known to impact gastric motility.
3. Any Gastric Surgery
4. Pregnancy or lactation, determined by pregnancy test at timeof enrolment.
5. Known allergy to adhesives and/or skin sensitivities, or any allergy to liraglutide or any components of the liraglutide/Saxenda formulation, or known hypersensitivity to Spirulina, egg, milk or wheat allergens
6. Use of GLP-1 agonist and/or on regular insulin in the past 3months.
7. History of gastroduodenal dysfunction and/or meets the ROME IV symptom criteria for a gastroduodenal disorder of gut-brain interaction (functional dyspepsia, chronic nausea and vomiting syndrome, cyclic vomiting syndrome, rumination syndrome, cannabinoid hyperemesis syndrome, or a belching disorder).
8. History of peptic ulcer, pancreatitis, cholelithiasis, choledocholithiasis, History of kidney or hepatic dysfunction
9. History of psychiatric disturbance requiring medication in the year before enrolment, any history of suicide attempt or eating disorder
10. History of Type II Diabetes or glucose intolerance (treated or untreated)
11. History of cancer other than basal cell skin cancer, and patients with personal or family history of medullary thyroid carcinoma (MTC) or in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2)
12. History of angioedema or urticaria disorder
13. History of cardiac disorder or arrhythmia
14. Any tobacco, vaping or cannabinoid use in the 30 days prior to study
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/05/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/11/2024
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Sample size
Target
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Accrual to date
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Final
22
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Alimetry
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Aim 1: To investigate, in healthy participants, the effect of liraglutide injection on gastric electrophysiology (as measured by body surface gastric mapping using the Gastric Alimetry device) during an 13-dayramping dose of liraglutide and subsequent washout. Aim 2: Assessment of effect of liraglutide injection on gastrointestinal symptoms and gut-brain wellbeing (as measured by validated symptom App and Alimetry gut-brain wellness Scale, respectively) during an 13-day ramping dose of liraglutide and subsequent washout.
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Trial website
https://clinicaltrials.gov/study/NCT06500130
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Schynell Coutinho, MSc Nutrition and Dietetics
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Address
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Country
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Phone
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(+64)2102225057
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Fax
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Email
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[email protected]
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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/NCT06500130
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