Body Surface Gastric Mapping in Patients on Semaglutide

University of Western Sydney

Status

Enrolling

Conditions

Gastroparesis

Semaglutide-Induced Gastric Motility

Treatments

Device: Gastric Alimetry

Study type

Observational

Funder types

Other

Identifiers

NCT06401746

WS-GLP-001

Details and patient eligibility

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.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.