NCT06401746 Body Surface Gastric Mapping in Patients on Semaglutide
| NCT ID | NCT06401746 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Western Sydney |
| Condition | Semaglutide-Induced Gastric Motility |
| Study Type | OBSERVATIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2025-03-13 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15 participants in total. It began in 2024-05-01 with a primary completion date of 2025-03-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Vincent Ho, MBBS, FRACP, FACP, PhD
PRINCIPAL INVESTIGATOR
Western Sydney University
Frequently Asked Questions
Who can join the NCT06401746 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Semaglutide-Induced Gastric Motility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06401746 currently recruiting?
Yes, NCT06401746 is actively recruiting participants. Contact the research team at d.foong@westernsydney.edu.au for enrollment information.
Where is the NCT06401746 trial being conducted?
This trial is being conducted at Campbelltown, Australia.
Who is sponsoring the NCT06401746 clinical trial?
NCT06401746 is sponsored by University of Western Sydney. The principal investigator is Vincent Ho, MBBS, FRACP, FACP, PhD at Western Sydney University. The trial plans to enroll 15 participants.