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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
15/07/2024

Titles & IDs
Public title
Effects of Liraglutide on Body Surface Gastric Mapping
Scientific title
Effects of Liraglutide on Body Surface Gastric Mapping
Secondary ID [1] 0 0
2024 FULL 19945
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroparesis 0 0
Functional Dyspepsia 0 0
Chronic Nausea and Vomiting Syndrome 0 0
Healthy 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
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in overall postprandial BSGM Gastric Alimetry Rhythm Index (GA-RI) on treatment compared to baseline.
Timepoint [1] 0 0
2 weeks
Secondary outcome [1] 0 0
Change in the following symptoms on treatment compared to baseline
Timepoint [1] 0 0
2 weeks
Secondary outcome [2] 0 0
Change in overall postprandial BMI-adjusted amplitude on treatment compared to baseline
Timepoint [2] 0 0
2 weeks
Secondary outcome [3] 0 0
Change in GA-RI on treatment to washout
Timepoint [3] 0 0
1 week
Secondary outcome [4] 0 0
Change in BMI-adjusted amplitude on treatment to washout
Timepoint [4] 0 0
1 week
Secondary outcome [5] 0 0
Correlation of total symptom burden with change in GA-RI
Timepoint [5] 0 0
4 weeks
Secondary outcome [6] 0 0
Correlation of total symptom burden with change in BMI-adjusted amplitude
Timepoint [6] 0 0
4 weeks
Secondary outcome [7] 0 0
Change in gastric emptying half-time on treatment compared to baseline
Timepoint [7] 0 0
2 weeks
Secondary outcome [8] 0 0
Correlation of gastric emptying half-time with GA-RI on treatment
Timepoint [8] 0 0
2 weeks
Secondary outcome [9] 0 0
Correlation of gastric emptying half-time with total symptom burden on treatment
Timepoint [9] 0 0
2 weeks

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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
2/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alimetry
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT06500130
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Schynell Coutinho, MSc Nutrition and Dietetics
Address 0 0
Country 0 0
Phone 0 0
(+64)2102225057
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06500130