Body Surface Gastric Mapping in Patients on Semaglutide

Sponsor
University of Western Sydney
Study ID
NCT06401746
Status
Recruiting
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Conditions

  • Gastroparesis
  • Semaglutide-Induced Gastric Motility

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gastric Alimetry — DEVICE
    The Gastric Alimetry™ System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.

Study Details

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.

Key Dates

First listed
May 7, 2024
Start date
May 1, 2024
Status verified
Dec 2024
Primary completion
Mar 13, 2025
Completion
Jun 1, 2025

Study Design

Enrollment
15 participants (estimated)

Arms

  • Arm: Semaglutide
    Patients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide.

Primary Outcome Measure

Change in overall postprandial BSGM Gastric Alimetry Rhythm Index (minimum: 0; maximum: 1) on treatment compared to baseline (with a lower score meaning worse outcome). [ Time Frame: 3 months ]

Central Contacts

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