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Clinical Trial NCT06401746 for Semaglutide-Induced Gastric Motility, Gastroparesis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Body Surface Gastric Mapping in Patients on Semaglutide 15 Non-Invasive Biomarker-Driven Medical Device Novel Treatment
Clinical Trial NCT06401746 is an observational study for Semaglutide-Induced Gastric Motility, Gastroparesis that is recruiting. It started on May 1, 2024 with plans to enroll 15 participants. Led by University of Western Sydney, it is expected to complete by June 1, 2025. The latest data from ClinicalTrials.gov was last updated on March 26, 2025.
Brief 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 gastrointesti...Show More
Official Title
Assessment of Gastric Function Using Body Surface Gastric Mapping in Patients on Semaglutide (Ozempic)
Conditions
Semaglutide-Induced Gastric MotilityGastroparesisPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- WS-GLP-001
NCT ID Number
Start Date (Actual)
2024-05-01
Last Update Posted
2025-03-26
Completion Date (Estimated)
2025-06-01
Enrollment (Estimated)
15
Study Type
Observational
Status
Recruiting
Keywords
Semaglutide
GLP-1 Receptor Agonist
Gastric Motility
Body Surface Gastric Mapping
GLP-1 Receptor Agonist
Gastric Motility
Body Surface Gastric Mapping
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Semaglutide Patients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide. | Gastric Alimetry 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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). | 3 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in Gastroparesis Cardinal Symptom Index (minimum: 0; maximum: 5) scores on treatment compared to baseline (with a higher score meaning worse outcome). | 3 months | |
Change in Patient Assessment of Upper Gastrointestinal Symptom Severity Index (minimum: 0; maximum: 5) scores on treatment compared to baseline (with a higher score meaning worse outcome). | 3 months | |
Change in Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (minimum: 0; maximum: 5) scores on treatment compared to baseline (with a lower score meaning worse outcome). | 3 months. | |
Change in 5-level EQ-5D (minimum: 0; maximum: 1) scores on treatment compared to baseline (with a lower score meaning worse outcome). | 3 months. | |
Change in Patient Health Questionnaire -8 (minimum: 0; maximum: 24) scores on treatment compared to baseline (with a higher score meaning worse outcome). | 3 months. | |
Change in General Anxiety Disorder-7 (minimum: 0; maximum: 21) scores on treatment compared to baseline (with a higher score meaning worse outcome). | 3 months. | |
Change in Perceived Stress Scale-4 (minimum: 0; maximum: 4) scores on treatment compared to baseline (with a higher score meaning worse outcome). | 3 months. | |
Correlation of postprandial BSGM Gastric Alimetry Rhythm Index (minimum: 0; maximum: 1) with symptom score (with a higher correlation meaning worse outcome). | Symptoms scales are Gastroparesis Cardinal Symptom Index (minimum: 0; maximum: 5) and Patient Assessment of Upper Gastrointestinal Symptom Severity Index (minimum: 0; maximum: 5). | 3 months. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- >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
- 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.
University of Western SydneyUniversity of Auckland, New ZealandStudy Responsible Party
Vincent Ho, Principal Investigator, Associate Professor, University of Western Sydney
Study Central Contact
Contact: Daphne Foong, PhD, +61 2 4634 4579, [email protected]
1 Study Locations in 1 Countries
New South Wales
Western Sydney University, Campbelltown, New South Wales, 2560, Australia
Daphne Foong, PhD, Contact, +61 2 4634 4579, [email protected]
Recruiting