NCT06401746

Body Surface Gastric Mapping in Patients on Semaglutide

Assessment of Gastric Function Using Body Surface Gastric Mapping in Patients on Semaglutide (Ozempic)
University of Western Sydney·ClinicalTrials.gov·device·Device trialRecruiting
View on ClinicalTrials.gov
Study focus
Drug/Device/Intervention
Gastric Alimetry
Study type
Observational
Intervention type
device
Sponsor & location
Primary sponsor
University of Western Sydney
Location
Campbelltown, Australia
Timeline & enrollment
Phase
N/A
Start date
May 01, 2024
End date
Mar 01, 2025
Enrollment
15 participants
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
Gastric ulcerSézary diseaseGastro-oesophageal reflux diseaseAttention to gastrostomyGastric ulcer : chronic or unspecified with haemorrhage
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06401746
Type
Device Trial
About this record

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.