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NCT Number: NCT06401746

Body Surface Gastric Mapping in Patients on Semaglutide

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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Key information

Conditions

Semaglutide-Induced Gastric Motility Digestive System Diseases Gastrointestinal Diseases Gastroparesis Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Western Sydney University

Campbelltown, New South Wales, 2560, Australia

Location status: Recruiting

Location contact

Daphne Foong, PhD

CONTACT

[email protected]

+61 2 4634 4579

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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).

    Time frame: 3 months

Secondary outcomes

  1. 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

  2. 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. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Daphne Foong, PhD

CONTACT

[email protected]

+61 2 4634 4579

Sponsors and collaborators

Lead sponsor

University of Western Sydney

Other

Collaborators

  • University of Auckland, New Zealand

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 7, 2024
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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