Body Surface Gastric Mapping in Patients on Semaglutide

NCT06401746 | Recruiting

• 1 other identifier: WS-GLP-001
• Study Type: observational
• Target: 15
• 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 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 Outcomes (8)

• 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 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 5-level EQ-5D (minimum: 0; maximum: 1) scores on treatment compared to baseline (with a lower 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.

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

RECRUITING

Related Publications (3)

• Kryger RA, Kolata JJ, Chung W, Dixit S, Tighe RJ, Vega JJ, DeYoung PA, Copi C, Sarafa J, Kovar DG, Gilfoyle GP, Sigworth SK. Two-particle correlations from neutron-light-charged-particle coincidences. Phys Rev Lett. 1990 Oct 22;65(17):2118-2121. doi: 10.1103/PhysRevLett.65.2118. No abstract available.

  PMID: 10042458 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

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

Study Officials

• Vincent Ho, MBBS, FRACP, FACP, PhD

  Western Sydney University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daphne Foong, PhD

CONTACT

+61 2 4634 4579; d.foong@westernsydney.edu.au

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: March 26, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)