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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06401746




Registration number
NCT06401746
Ethics application status
Date submitted
28/04/2024
Date registered
7/05/2024
Date last updated
9/05/2024

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
Glucagon-like receptor-1 agonists (GLP-1 RAs), such as Semaglutide (Ozempic), are a class of
drugs used for glycemic control in diabetes, and for weight loss and management in obesity.
It has been shown to delay gastric emptying and lead to gastrointestinal symptoms. However,
the exact mechanisms are unknown. Alterations in gastric function, including myoelectrical
activity, may be a likely mechanism of gastrointestinal side effects.

Body Surface Gastric Mapping (BSGM) using the FDA-approved medical device Gastric Alimetry is
a novel non-invasive diagnostic tool to assess gastric myoelectrical activity and
patient-reported symptoms to achieve accurate non-invasive biomarkers of gastric dysfunction.
A proof-of-principle case study of Ozempic using Gastric Alimetry showed abnormal gastric
myoelectrical activity along with the development of severe bloating following the meal after
5 weeks of Ozempic use.

This study will extend on this initial finding by conducting an exploratory pilot study to
investigate the effects on gastric motility in patients with and without diabetes before and
after Ozempic. It is hypothesized that Gastric Alimetry will show changes in gastric
myoelectrical activity and symptoms in patients after being on the weekly injectable Ozempic
compared to baseline.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06401746
Trial related presentations / publications
Gharibans AA, Calder S, Varghese C, Waite S, Schamberg G, Daker C, Du P, Alighaleh S, Carson D, Woodhead J, Farrugia G, Windsor JA, Andrews CN, O'Grady G. Gastric dysfunction in patients with chronic nausea and vomiting syndromes defined by a noninvasive gastric mapping device. Sci Transl Med. 2022 Sep 21;14(663):eabq3544. doi: 10.1126/scitranslmed.abq3544. Epub 2022 Sep 21.
Wang WJ, Foong D, Calder S, Schamberg G, Varghese C, Tack J, Xu W, Daker C, Carson D, Waite S, Hayes T, Du P, Abell TL, Parkman HP, Huang IH, Fernandes V, Andrews CN, Gharibans AA, Ho V, O'Grady G. Gastric Alimetry Expands Patient Phenotyping in Gastroduodenal Disorders Compared with Gastric Emptying Scintigraphy. Am J Gastroenterol. 2024 Feb 1;119(2):331-341. doi: 10.14309/ajg.0000000000002528. Epub 2023 Oct 30.
Varghese C, Schamberg G, Calder S, Waite S, Carson D, Foong D, Wang WJ, Ho V, Woodhead J, Daker C, Xu W, Du P, Abell TL, Parkman HP, Tack J, Andrews CN, O'Grady G, Gharibans AA. Normative Values for Body Surface Gastric Mapping Evaluations of Gastric Motility Using Gastric Alimetry: Spectral Analysis. Am J Gastroenterol. 2023 Jun 1;118(6):1047-1057. doi: 10.14309/ajg.0000000000002077. Epub 2022 Dec 20.
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
d.foong@westernsydney.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06401746