Body Surface Gastric Mapping in Patients on Semaglutide

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Gastroparesis

Clinical Trial Details

NCT number	NCT06401746
Study type	Observational
Source	University of Western Sydney
Contact	Daphne Foong, PhD
Phone	+61 2 4634 4579
Email	d.foong@westernsydney.edu.au
Status	Recruiting
Phase
Start date	May 1, 2024
Completion date	March 1, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03941288` - Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia	Phase 2
Terminated	`NCT03285308` - A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01	Phase 3
Completed	`NCT00733551` - Evaluation of the Safety, Tolerability and Pharmacokinetics of Repeat Oral Doses of GSK962040 Administered to Healthy Adult Subjects.	Phase 1
Completed	`NCT01650714` - Endoscopic Full Thickness Biopsy, Gastric Wall.	N/A
Completed	`NCT01452815` - Affects of Once-daily Oral Administration of TZP-102 on the Treatment of Symptoms Associated With Diabetic Gastroparesis	Phase 2
Completed	`NCT01039974` - GSK962040 Drug-drug Interaction Study With Ketoconazole	Phase 1
Terminated	`NCT04844190` - Use of EndoFLIP and Manometry Prior to G-POEM	N/A
Enrolling by invitation	`NCT06215547` - Medtronic Enterra II Neurostimulator	N/A
Completed	`NCT04026997` - A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis	Phase 2
Completed	`NCT00562848` - A Study to Evaluate Safety, Side Effects, Muscle Activity and Speed of Gastric Emptying of GSK962040	Phase 1
Enrolling by invitation	`NCT04207996` - Vagus Nerve Response in Gastroparesis Patients
Completed	`NCT04607304` - ABCA2 GIRMS Analytical Validation Clinical Performance Study	N/A
Recruiting	`NCT06068114` - Gastric Pathophysiology in Diabetes
Completed	`NCT03259841` - Ultrasound Assessment of Gastric Contents in Fasted Patient Undergoing Cholecystectomy
Active, not recruiting	`NCT04300127` - Pioglitazone for Idiopathic Gastroparesis	Early Phase 1
Recruiting	`NCT01696734` - Domperidone in Treating Patients With Gastrointestinal Disorders	Phase 3
Terminated	`NCT04635306` - 13C-Spirulina Nitrogen Content GEBT Study	N/A
Withdrawn	`NCT02420925` - Effect of Celiac Plexus Block on Gastric Emptying and Symptoms Caused by Gastroparesis	N/A
Recruiting	`NCT00777439` - Domperidone for Refractory Gastrointestinal Disorders	N/A
Terminated	`NCT00760461` - Domperidone in Refractory Gastroparesis	Phase 2