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| Name | Class |
|---|---|
| University of Auckland, New Zealand | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Patients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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). | 3 months |
| 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). | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with or without Type 2 Diabetes Mellitus who are prescribed Semaglutide in a general metabolic clinic.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daphne Foong, PhD | Contact | +61 2 4634 4579 | d.foong@westernsydney.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Vincent Ho, MBBS, FRACP, FACP, PhD | Western Sydney University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Sydney University | Recruiting | Campbelltown | New South Wales | 2560 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36130019 | Background | 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. | |
| 37782524 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 28, 2026 | |
| Reset | May 19, 2026 | |
| Release | May 22, 2026 | |
| Reset | Jun 18, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 28, 2026 | May 19, 2026 | |||
| May 22, 2026 |
| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| 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. |
| Change in General Anxiety Disorder-7 (minimum: 0; maximum: 21) scores on treatment compared to baseline (with a higher score meaning worse outcome). | 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). | 3 months. |
| Correlation of postprandial BSGM Gastric Alimetry Rhythm Index (minimum: 0; maximum: 1) with symptom score (with a higher correlation meaning worse outcome). | 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. |
| 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. |
| 36534985 | 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. |
| Jun 18, 2026 |
| Jul 3, 2026 |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |