Body Surface Gastric Mapping in Patients on Semaglutide

March 23, 2025 updated by: Vincent Ho, University of Western Sydney

Assessment of Gastric Function Using Body Surface Gastric Mapping in Patients on Semaglutide (Ozempic)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with or without Type 2 Diabetes Mellitus who are prescribed Semaglutide in a general metabolic clinic.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Semaglutide
Patients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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).
Time Frame: 3 months
3 months

Secondary Outcome Measures

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).
Time Frame: 3 months
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).
Time Frame: 3 months
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).
Time Frame: 3 months.
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).
Time Frame: 3 months.
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).
Time Frame: 3 months.
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).
Time Frame: 3 months.
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).
Time Frame: 3 months.
3 months.
Correlation of postprandial BSGM Gastric Alimetry Rhythm Index (minimum: 0; maximum: 1) with symptom score (with a higher correlation meaning worse outcome).
Time Frame: 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).
3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Western Sydney

Collaborators

University of Auckland, New Zealand

Investigators

  • Principal Investigator: Vincent Ho, MBBS, FRACP, FACP, PhD, Western Sydney University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

March 13, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

April 28, 2024

First Submitted That Met QC Criteria

May 4, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Estimated)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 23, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WS-GLP-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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