Gastric dysfunction in patients with chronic nausea and vomiting syndromes defined by a noninvasive gastric mapping device.
Armen A Gharibans, Stefan Calder, Chris Varghese...
https://pubmed.ncbi.nlm.nih.gov/36130019Actively Recruiting
Age: 18Years +
All Genders
ID06401746
Assessment of Gastric Function Using Body Surface Gastric Mapping in Patients on Semaglutide (Ozempic)
Led by University of Western Sydney · Updated on 2025-03-26
15
Participants Needed
1
Research Sites
11 weeks
Total Duration
On this page
Sponsors
U
University of Western Sydney
Lead Sponsor
U
University of Auckland, New Zealand
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effects of Semaglutide (Ozempic), a glucagon-like receptor-1 agonist used for diabetes and weight management, on gastric motility and symptoms. This observational study aims to understand the changes in gastric myoelectrical activity and gastrointestinal symptoms in patients with and without diabetes using a novel non-invasive diagnostic device called Gastric Alimetry. The study builds on initial findings that showed abnormal gastric activity and severe bloating after Semaglutide use. Participants will undergo Body Surface Gastric Mapping using the FDA-approved Gastric Alimetry device before and after starting weekly injectable Semaglutide treatment. The study will compare gastric function and symptom changes from baseline to three months on treatment. This approach seeks to identify accurate non-invasive biomarkers of gastric dysfunction related to Semaglutide use. During the study, participants will have assessments of gastric myoelectrical activity and report their symptoms using several scales over three months. Researchers will monitor changes in gastric rhythm, symptom severity, quality of life, anxiety, stress, and other patient-reported outcomes. The primary outcome is the change in post-meal Gastric Alimetry Rhythm Index. The study will provide insight into gastric function alterations linked to Semaglutide use and their symptoms.
CONDITIONS
Brief Title
Body Surface Gastric Mapping in Patients on Semaglutide
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults older than 18 years
- No gastrointestinal symptoms based on Rome IV criteria
- For diabetics: Diagnosed type 2 diabetes with HbA1c levels above 7%
- For diabetics: Fasting blood glucose level below 15 mmol/L
You will not qualify if you...
- Current use of Ozempic, similar GLP-1 receptor agonists, or regular insulin in the last 3 months
- Confirmed gastroparesis diagnosed by gastric emptying scintigraphy
- Pregnant or breastfeeding women
- Inability to perform Body Surface Gastric Mapping test due to severe skin allergies, sensitive or damaged epigastric skin, or inability to remain relaxed in a reclined position during the test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Baseline assessment
Participants undergo Body Surface Gastric Mapping to assess gastric function before starting Semaglutide treatment.
1 visit (in-person)
Monitoring
Duration - 3 months
Participants are observed during treatment with Semaglutide to monitor changes in gastric function and related symptoms.
Visits at baseline and after 3 months of treatment
Trial Site Locations
Total: 1 location
1
Western Sydney University
Campbelltown, New South Wales, Australia, 2560
Actively Recruiting
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Research Team
D
Daphne Foong, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Gastric Alimetry Expands Patient Phenotyping in Gastroduodenal Disorders Compared with Gastric Emptying Scintigraphy.
William Jiaen Wang, Daphne Foong, Stefan Calder...
https://pubmed.ncbi.nlm.nih.gov/37782524Normative Values for Body Surface Gastric Mapping Evaluations of Gastric Motility Using Gastric Alimetry: Spectral Analysis.
Chris Varghese, Gabriel Schamberg, Stefan Calder...
https://pubmed.ncbi.nlm.nih.gov/36534985