Body Surface Gastric Mapping in Patients on Semaglutide

NCT06401746 | Completed Results

• 1 other identifier: WS-GLP-001
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Semaglutide-Induced Gastric Motility; Gastroparesis

Keywords

Semaglutide; GLP-1 Receptor Agonist; Gastric Motility; Body Surface Gastric Mapping

Outcome Measures

Primary Outcomes (1)

• Change in Overall BSGM BMI-adjusted Amplitude on Drug Compared to Baseline.

  Amplitude is a measure of the strength of contractions. It has a normative reference range between 22-70 microvolts; values outside this range indicate a worse outcome. Minimum: 0.

  Baseline, Month 2 (On Drug)

Secondary Outcomes (8)

• Change in Overall BSGM Principal Gastric Frequency on Drug Compared to Baseline.

  Baseline, Month 2 (On Drug)

• Change in Overall BSGM Gastric Alimetry Rhythm Index on Drug Compared to Baseline.

  Baseline, Month 2 (On Drug)

• Change in Overall BSGM Fed:Fasted Amplitude Ratio on Drug Compared to Baseline.

  Baseline, Month 2 (On Drug)

• Change in Overall BSGM Meal Response Ratio on Drug Compared to Baseline.

  Baseline, Month 2 (On Drug)

• Change in Total Symptom Burden Score on Drug Compared to Baseline.

  Baseline, 2 Months (On Drug)

Study Arms (1)

Semaglutide

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

Device: Gastric Alimetry

Interventions

Gastric Alimetry 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.

Semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• \>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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Western Sydney: lead
• University of Auckland, New Zealand: collaborator

Study Sites (1)

Western Sydney University

Campbelltown, New South Wales, 2560, Australia

Location

Related Publications (4)

• Gharibans AA, Calder S, Varghese C, Waite S, Schamberg G, Daker C, Du P, Alighaleh S, Carson D, Woodhead J, Farrugia G, Windsor JA, Andrews CN, O'Grady G. Gastric dysfunction in patients with chronic nausea and vomiting syndromes defined by a noninvasive gastric mapping device. Sci Transl Med. 2022 Sep 21;14(663):eabq3544. doi: 10.1126/scitranslmed.abq3544. Epub 2022 Sep 21.

  PMID: 36130019 BACKGROUND

• Wang WJ, Foong D, Calder S, Schamberg G, Varghese C, Tack J, Xu W, Daker C, Carson D, Waite S, Hayes T, Du P, Abell TL, Parkman HP, Huang IH, Fernandes V, Andrews CN, Gharibans AA, Ho V, O'Grady G. Gastric Alimetry Expands Patient Phenotyping in Gastroduodenal Disorders Compared with Gastric Emptying Scintigraphy. Am J Gastroenterol. 2024 Feb 1;119(2):331-341. doi: 10.14309/ajg.0000000000002528. Epub 2023 Oct 30.

  PMID: 37782524 BACKGROUND

• Varghese C, Schamberg G, Calder S, Waite S, Carson D, Foong D, Wang WJ, Ho V, Woodhead J, Daker C, Xu W, Du P, Abell TL, Parkman HP, Tack J, Andrews CN, O'Grady G, Gharibans AA. Normative Values for Body Surface Gastric Mapping Evaluations of Gastric Motility Using Gastric Alimetry: Spectral Analysis. Am J Gastroenterol. 2023 Jun 1;118(6):1047-1057. doi: 10.14309/ajg.0000000000002077. Epub 2022 Dec 20.

  PMID: 36534985 BACKGROUND

• Abraham R, Foong D, Piya M, Grudzinskas K, Ho V. Semaglutide Induces Changes in Gastric Electrical Activity in Patients With Overweight and Obesity: A Pilot Study. J Neurogastroenterol Motil. 2026 Apr 30;32(2):237-243. doi: 10.5056/jnm25156.

  PMID: 41952406 RESULT

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Daphne Foong
• Organization: Western Sydney University

d.foong@westernsydney.edu.au

NA

Study Officials

• Vincent Ho, MBBS, FRACP, FACP, PhD

  Western Sydney University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: May 7, 2024
• Study Start: May 1, 2024
• Primary Completion: March 13, 2025
• Study Completion: June 1, 2025
• Last Updated: August 31, 2026
• Results First Posted: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)