Body Surface Gastric Mapping in Patients on Semaglutide

Recruiting

• Conditions: Semaglutide-Induced Gastric Motility; Gastroparesis
• Interventions: Device: Gastric Alimetry

• Registration Number: NCT06401746
• Lead Sponsor: University of Western Sydney

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-28
• Study Start: 2024-05-01
• Study First Submitted QC: 2024-05-04
• Study First Posted: 2024-05-07
• Status Verified: 2024-12
• Primary Completion: 2025-03-13
• Last Update Submitted: 2025-03-23
• Last Update Posted: 2025-03-26
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• >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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Semaglutide	Gastric Alimetry	Patients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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.
Correlation of postprandial BSGM Gastric Alimetry Rhythm Index (minimum: 0; maximum: 1) with symptom score (with a higher correlation meaning worse outcome).	3 months.	Symptoms scales are Gastroparesis Cardinal Symptom Index (minimum: 0; maximum: 5) and Patient Assessment of Upper Gastrointestinal Symptom Severity Index (minimum: 0; maximum: 5).
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 Health Questionnaire -8 (minimum: 0; maximum: 24) 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 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.

Trial Locations

Locations (1)

Western Sydney University; 🇦🇺 Campbelltown, New South Wales, Australia