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Набира участници NCT06401746

Body Surface Gastric Mapping in Patients on Semaglutide

Заболявания: Semaglutide-Induced Gastric Motility Gastroparesis

Спонсор: University of Western Sydney

Налично на: БГ
Обобщение
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.
Кой може да участва
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.
Места на провеждане 1
Австралия (1)
Western Sydney University
Campbelltown , New South Wales
Технически детайли
Статус
Набира участници
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
01.05.2024
Крайна дата
01.06.2025
Регистрационен номер
NCT06401746
Източник
anzctr
Запитване за медицински туризъм

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