Body Surface Gastric Mapping in Patients on Semaglutide

Launched by UNIVERSITY OF WESTERN SYDNEY · May 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called Semaglutide (often known by its brand name Ozempic) affects stomach function in people with and without diabetes. Semaglutide is used for managing blood sugar levels in diabetes and for weight loss, but it can cause stomach issues like bloating and delayed gastric emptying. Researchers want to understand the mechanisms behind these side effects by using a new, non-invasive test called Body Surface Gastric Mapping (BSGM), which measures stomach activity and collects information about patients' symptoms.

To be eligible for this study, participants must be over 18 years old and not have any gastrointestinal symptoms according to specific criteria. For those with diabetes, they need to have a certain level of blood sugar. However, people who have used Ozempic or similar medications in the last three months, have confirmed gastroparesis (a condition where the stomach can't empty properly), are pregnant or breastfeeding, or have certain skin conditions cannot participate. If you join the study, you can expect to undergo a simple test that measures your stomach's electrical activity, with the goal of better understanding how Semaglutide affects your digestive system.

Gender

ALL

Eligibility criteria

• 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.