Actively Recruiting
Body Surface Gastric Mapping in Patients on Semaglutide
Led by University of Western Sydney · Updated on 2025-03-26
15
Participants Needed
1
Research Sites
56 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
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.
CONDITIONS
Official Title
Body Surface Gastric Mapping in Patients on Semaglutide
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be older than 18 years
- No gastrointestinal symptoms based on Rome IV criteria
- Diagnosed with type 2 diabetes mellitus (HbA1c > 7%) for diabetic participants
- Fasting blood glucose level less than 15 mmol/L for diabetic participants
You will not qualify if you...
- Use of Ozempic, similar GLP-1 receptor agonists, or regular insulin in the past 3 months
- Confirmed gastroparesis diagnosed by gastric emptying scintigraphy
- Pregnant or breastfeeding
- Unable to perform the Body Surface Gastric Mapping test due to severe skin allergies, sensitive skin, fragile skin, wounds, inflammation, or inability to remain in a relaxed reclined position for the test duration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Western Sydney University
Campbelltown, New South Wales, Australia, 2560
Actively Recruiting
Research Team
D
Daphne Foong, PhD
CONTACT
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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