CompletedNot Applicable

Effects of Liraglutide on Body Surface Gastric Mapping

New Zealand22 participantsStarted 2024-05-30

Plain-language summary

Aim 1: To investigate, in healthy participants, the effect of liraglutide injection on gastric electrophysiology (as measured by body surface gastric mapping using the Gastric Alimetry device) during an 13-dayramping dose of liraglutide and subsequent washout. Aim 2: Assessment of effect of liraglutide injection on gastrointestinal symptoms and gut-brain wellbeing (as measured by validated symptom App and Alimetry gut-brain wellness Scale, respectively) during an 13-day ramping dose of liraglutide and subsequent washout.

Who can participate

Age range18 Years – 65 Years

SexALL

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Exclusion criteria

✕. Confirmed diagnosis of a comorbidity known to affect gastric motility (i.e., Parkinson\'s Disease, Type 1 or 2 Diabetes).
✕. Medications in the last 3 months known to impact gastric motility.
✕. Any Gastric Surgery
✕. Pregnancy or lactation, determined by pregnancy test at timeof enrolment.
✕. Known allergy to adhesives and/or skin sensitivities, or any allergy to liraglutide or any components of the liraglutide/Saxenda formulation, or known hypersensitivity to Spirulina, egg, milk or wheat allergens
✕. Use of GLP-1 agonist and/or on regular insulin in the past 3months.
✕. History of gastroduodenal dysfunction and/or meets the ROME IV symptom criteria for a gastroduodenal disorder of gut-brain interaction (functional dyspepsia, chronic nausea and vomiting syndrome, cyclic vomiting syndrome, rumination syndrome, cannabinoid hyperemesis syndrome, or a belching disorder).
✕. History of peptic ulcer, pancreatitis, cholelithiasis, choledocholithiasis, History of kidney or hepatic dysfunction

What they're measuring

Change in overall postprandial BSGM Gastric Alimetry Rhythm Index (GA-RI) on treatment compared to baseline.

Timeframe: 2 weeks

Trial details

NCT IDNCT06500130

SponsorAlimetry

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-30

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