Body Surface Gastric Mapping in Patients on Semaglutide

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Semaglutide-Induced Gastric Motility Gastroparesis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Semaglutide

Patients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide.

Gastric Alimetry

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No