Mapping gastric activity in patients using Semaglutide
Assessment of Gastric Function Using Body Surface Gastric Mapping in Patients on Semaglutide (Ozempic)
This study is testing how the diabetes drug Semaglutide affects stomach activity in patients and if it relates to their gastrointestinal symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Western Sydney Academic / other |
| Locations | 1 site (Campbelltown, New South Wales) |
| Trial ID | NCT06401746 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the effects of Semaglutide on gastric motility using a non-invasive diagnostic tool called Body Surface Gastric Mapping (BSGM). The study will assess gastric myoelectrical activity and correlate it with patient-reported gastrointestinal symptoms. By utilizing Gastric Alimetry, researchers hope to identify biomarkers of gastric dysfunction associated with Semaglutide treatment. This pilot study builds on previous findings that indicated abnormal gastric activity in patients using Semaglutide.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with type 2 diabetes who do not exhibit gastrointestinal symptoms.
Not a fit: Patients currently using Semaglutide or similar medications, or those with confirmed gastroparesis, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the mechanisms behind gastric side effects of Semaglutide, leading to better management of these symptoms.
How similar studies have performed: While this approach is novel, preliminary case studies have shown abnormal gastric activity in patients using Semaglutide, suggesting potential for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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.
Where this trial is running
Campbelltown, New South Wales
- Western Sydney University — Campbelltown, New South Wales, Australia (Recruiting)
Study contacts
- Principal investigator: Vincent Ho, MBBS, FRACP, FACP, PhD — Western Sydney University
- Study coordinator: Daphne Foong, PhD
- Email: d.foong@westernsydney.edu.au
- Phone: +61 2 4634 4579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.