Ignite Creation Date:
2024-07-17 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500130
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
Effects of Liraglutide on Body Surface Gastric Mapping
Sponsor:
Alimetry
Organization:
Alimetry
Study Overview
Official Title:
Effects of Liraglutide on Body Surface Gastric Mapping
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Detailed Description:
Globally more than 40 of persons have a functional gastrointestinalGI disorder based on the Rome IV diagnostic questionnaire These disorders encompass gastroparesis and chronic nausea and vomiting syndromes CNVS including chronic unexplained nausea and vomitingCNV and cyclic vomiting syndrome CVS functional dyspepsia FD chronic indigestion and post-operative gastric dysfunction The disorders are linked by the fact that no obvious structural cause for their symptoms can be identified based on investigations such as endoscopy or imaging However there is still a lack of diagnostic biomarkers for these functional disorders Measuring gastric emptying rate with either scintigraphy or a breath test is the only clinically used test of gastric function if abnormal the patient is listed as having gastroparesis However this test fails to clearly explain the symptom pattern and severity does not predict response to therapy and changes in the test result do not correlate with evolution of clinical symptoms There is also substantial crossover in symptoms between functional dyspepsia and gastro-esophageal reflux disease and differentiating these condition scan be challenging
GLP-1 analogues cause GI distress and weight loss due to their effect on slowing gastric emptying inducing satiety or loss of appetite and thus reducing oral intake GI symptoms such as nausea similar to symptoms of gastroparesis are the most common reason for discontinuation of these drugs Gastric Alimetry GA is a new device which measures gastric electrophysiology We postulate that GA will show changes in gastric spectral analysis as well as symptoms in healthy volunteers on a once daily injectable GLP-1 analogue liraglutide
References
Sperber AD Bangdiwala SI Drossman DA Ghoshal UC Simren M TackJ Whitehead WE Dumitrascu DL Fang X Fukudo S Kellow JWorldwide prevalence and burden of functional gastrointestinaldisorders results of Rome Foundation Global Study
Gastroenterology 2021160199-114 Pasricha PJ Grover M Yates KPAbell TL Bernard CE Koch KL McCallum RW Sarosiek I Kuo B BulatR Chen J Functional dyspepsia and gastroparesis in tertiary care areinterchangeable syndromes with common clinical and pathologicfeatures Gastroenterology 202116062006-17 Parkman Henry PDaniel S Rim Jonathan R Anolik Simin Dadparvar and Alan H Maurer2024 34Glucagonlike Peptide-1 Receptor Agonists The Good the Badand the Ugly-Benefits for Glucose Control and Weight Loss with SideEffects of Delaying Gastric Emptying34 Journal of Nuclear MedicineTechnology January httpsdoiorg102967jnmt123266800
GLP-1 analogues cause GI distress and weight loss due to their effect on slowing gastric emptying inducing satiety or loss of appetite and thus reducing oral intake GI symptoms such as nausea similar to symptoms of gastroparesis are the most common reason for discontinuation of these drugs Gastric Alimetry GA is a new device which measures gastric electrophysiology We postulate that GA will show changes in gastric spectral analysis as well as symptoms in healthy volunteers on a once daily injectable GLP-1 analogue liraglutide
References
Sperber AD Bangdiwala SI Drossman DA Ghoshal UC Simren M TackJ Whitehead WE Dumitrascu DL Fang X Fukudo S Kellow JWorldwide prevalence and burden of functional gastrointestinaldisorders results of Rome Foundation Global Study
Gastroenterology 2021160199-114 Pasricha PJ Grover M Yates KPAbell TL Bernard CE Koch KL McCallum RW Sarosiek I Kuo B BulatR Chen J Functional dyspepsia and gastroparesis in tertiary care areinterchangeable syndromes with common clinical and pathologicfeatures Gastroenterology 202116062006-17 Parkman Henry PDaniel S Rim Jonathan R Anolik Simin Dadparvar and Alan H Maurer2024 34Glucagonlike Peptide-1 Receptor Agonists The Good the Badand the Ugly-Benefits for Glucose Control and Weight Loss with SideEffects of Delaying Gastric Emptying34 Journal of Nuclear MedicineTechnology January httpsdoiorg102967jnmt123266800
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None