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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06401746




Registration number
NCT06401746
Ethics application status
Date submitted
28/04/2024
Date registered
7/05/2024

Titles & IDs
Public title
Body Surface Gastric Mapping in Patients on Semaglutide
Scientific title
Assessment of Gastric Function Using Body Surface Gastric Mapping in Patients on Semaglutide (Ozempic)
Secondary ID [1] 0 0
WS-GLP-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Semaglutide-Induced Gastric Motility 0 0
Gastroparesis 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
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Gastric Alimetry

Semaglutide - Patients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide.


Treatment: Devices: Gastric Alimetry
The Gastric Alimetry™ System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.
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 (minimum: 0; maximum: 1) on treatment compared to baseline (with a lower score meaning worse outcome).
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Change in Gastroparesis Cardinal Symptom Index (minimum: 0; maximum: 5) scores on treatment compared to baseline (with a higher score meaning worse outcome).
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Change in Patient Assessment of Upper Gastrointestinal Symptom Severity Index (minimum: 0; maximum: 5) scores on treatment compared to baseline (with a higher score meaning worse outcome).
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
Change in Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (minimum: 0; maximum: 5) scores on treatment compared to baseline (with a lower score meaning worse outcome).
Timepoint [3] 0 0
3 months.
Secondary outcome [4] 0 0
Change in 5-level EQ-5D (minimum: 0; maximum: 1) scores on treatment compared to baseline (with a lower score meaning worse outcome).
Timepoint [4] 0 0
3 months.
Secondary outcome [5] 0 0
Change in Patient Health Questionnaire -8 (minimum: 0; maximum: 24) scores on treatment compared to baseline (with a higher score meaning worse outcome).
Timepoint [5] 0 0
3 months.
Secondary outcome [6] 0 0
Change in General Anxiety Disorder-7 (minimum: 0; maximum: 21) scores on treatment compared to baseline (with a higher score meaning worse outcome).
Timepoint [6] 0 0
3 months.
Secondary outcome [7] 0 0
Change in Perceived Stress Scale-4 (minimum: 0; maximum: 4) scores on treatment compared to baseline (with a higher score meaning worse outcome).
Timepoint [7] 0 0
3 months.
Secondary outcome [8] 0 0
Correlation of postprandial BSGM Gastric Alimetry Rhythm Index (minimum: 0; maximum: 1) with symptom score (with a higher correlation meaning worse outcome).
Timepoint [8] 0 0
3 months.

Eligibility
Key inclusion criteria
* >18 years old
* No gastrointestinal symptoms based on Rome IV criteria
* For diabetics: Diagnosed T2DM (defined as HbA1c levels > 7%)
* For diabetics: Fasting blood glucose level < 15 mmol/L
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current use of Ozempic, similar GLP-1 RAs or regular insulin in the last 3 months
* Confirmed gastroparesis on gastric emptying scintigraphy
* Pregnant or breast-feeding
* Inability to perform a BSGM test according to Indications for Use: history of severe skin allergies or sensitivity to cosmetics or lotions; chronically damaged or vulnerable epigastric skin (fragile skin, wounds, inflammation); unable to remain in a relaxed reclined position for the test duration.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Western Sydney University - Campbelltown
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown

Funding & Sponsors
Primary sponsor type
Other
Name
University of Western Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Auckland, New Zealand
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Vincent Ho, MBBS, FRACP, FACP, PhD
Address 0 0
Western Sydney University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Daphne Foong, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 2 4634 4579
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT06401746