Assessment of Gastric Function Using Body Surface Gastric Mapping in Patients on Semaglutide (Ozempic)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \>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

Locations
Other Locations
Australia
Western Sydney University
RECRUITING
Campbelltown
Contact Information
Primary
Daphne Foong, PhD
d.foong@westernsydney.edu.au
+61 2 4634 4579
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 15
Treatments
Semaglutide
Patients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide.
Related Therapeutic Areas
Sponsors
Leads: University of Western Sydney
Collaborators: University of Auckland, New Zealand

This content was sourced from clinicaltrials.gov