Status:
COMPLETED
Effects of Liraglutide on Body Surface Gastric Mapping
Lead Sponsor:
Alimetry
Conditions:
Gastroparesis
Functional Dyspepsia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 ...
Detailed Description
Globally, more than 40% of persons have a functional gastrointestinal(GI) disorder based on the Rome IV diagnostic questionnaire. These disorders encompass gastroparesis and chronic nausea and vomitin...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form, AND
- Aged between 18 and 65 years old, AND
- Healthy volunteer with no previous history of gastrointestinal disorders/symptoms
- BMI 22-35
Exclusion
- 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
- History of psychiatric disturbance requiring medication in the year before enrolment, any history of suicide attempt or eating disorder
- History of Type II Diabetes or glucose intolerance (treated or untreated)
- History of cancer other than basal cell skin cancer, and patients with personal or family history of medullary thyroid carcinoma (MTC) or in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2)
- History of angioedema or urticaria disorder
- History of cardiac disorder or arrhythmia
- Any tobacco, vaping or cannabinoid use in the 30 days prior to study
Key Trial Info
Start Date :
May 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06500130
Start Date
May 30 2024
End Date
November 30 2024
Last Update
January 29 2025
Active Locations (1)
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1
Alimetry Clinic
Auckland, Auckland, New Zealand, 1010