Body Surface Gastric Mapping in Patients on Semaglutide - Trial NCT06401746
Access comprehensive clinical trial information for NCT06401746 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Western Sydney and is currently Recruiting. The study focuses on Semaglutide-Induced Gastric Motility,Gastroparesis. Target enrollment is 15 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
University of Western Sydney
Timeline & Enrollment
N/A
May 01, 2024
Mar 01, 2025
Primary Outcome
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).
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06401746
Device Trial