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Investigation of the Evolution of Gastric Emptying by Gastric Ultra Sonography in Patients Treated With GLP-1 Receptor Agonists on a 7 Days Pausing Period. 40 Observational

Not yet recruiting
Clinical Trial NCT06388213 is an observational study for Diabetes Mellitus, Type 2, Anesthesia, Pulmonary Aspiration of Gastric Contents and is currently not yet recruiting. Enrollment is planned to begin on 1 June 2024 and continue until the study accrues 40 participants. Led by University Hospital, Geneva, this study is expected to complete by 1 May 2026. The latest data from ClinicalTrials.gov was last updated on 1 May 2024.
Brief Summary
Glucagon-like-peptide-1 is a hormone released by the gut enteroendocrine cells. Its secretion occurs after each meal to enable production of insulin and inhibits the production of glucagon to lower after meal glycemia. It also inhibits gastric emptying and food intake. GLP-1 RA plays a role on GLP-1 receptors present on islet beta cells and delta cells of the pancreas to control insulin. GLP-1 receptors are also pres...Show More
Detailed Description
The study design consists in a prospective monocentric observational study comparing 2 groups of patients either treated by GLP-1 RA (more than 3 months) or without GLP-1 RA treatment. The investigators will perform a gastric echography, in both groups to define gastric residue after a fasting period of at least 6 hours for solids and 2 hours for liquids. Patients will have free access to any eating regimen before fa...Show More
Official Title

Investigation of Gastric Emptying in Patients Treated With GLP-1 Receptor Agonists

Conditions
Diabetes Mellitus, Type 2AnesthesiaPulmonary Aspiration of Gastric Contents
Other Study IDs
  • GLP-1 RA patients GE by GUS
NCT ID Number
NCT06388213
Start Date (Actual)
2024-06
Last Update Posted
2024-05-01
Completion Date (Estimated)
2026-05
Enrollment (Estimated)
40
Study Type
Observational
Status
Not yet recruiting
Keywords
Glucagon Like Peptide 1 Receptors Agonists
Gastric Emptying
Gastric Ultrasound
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Non GLP-1 RA group
Patient aged 18 years or older in healthy condition with no gastroparetic treatment and without history of gastro-intestinal pathology, respecting fasting period of 6 hours for solid or thick liquid (juice, milk, sparkling water and soda) and 2 hours for clear liquid (still water, black coffee or tea).
Gastric Ultrasonography
Evaluation of cross sectional area of the antrum by gastric ultrasonography in healthy patients and in patient treated by GLP-1 receptor agonists after a fasting period (6 hours for solid and 2 hours for clear liquids). For the GLP-1 receptor agonists group the gastric ultrasonochography will be repeated each 2 days during 7 days. In the non GLP-1 receptors agonists group the evaluation will be executed one time.
GLP-1 RA group
Patients aged 18 years or older, treated with GLP-1 receptor agonists, respecting fasting period of 6 hours for solid or thick liquid (juice, milk, sparkling water and soda) and 2 hours for clear liquid (still water, black coffee or tea).
Gastric Ultrasonography
Evaluation of cross sectional area of the antrum by gastric ultrasonography in healthy patients and in patient treated by GLP-1 receptor agonists after a fasting period (6 hours for solid and 2 hours for clear liquids). For the GLP-1 receptor agonists group the gastric ultrasonochography will be repeated each 2 days during 7 days. In the non GLP-1 receptors agonists group the evaluation will be executed one time.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change of antral cross sectional area in patients pausing 7 days GLP-1 RA treatment.
7 days
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Time course of change in gastric volume
7 days
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes

Patients over 18yrs old treated with GLP-1 receptor agonists for at least three months

Patients known for gastrointestinal motility disorders, history of gastric surgery, large hiatal hernia, or inability to lie in the right lateral decubitus position.
University Hospital, Geneva logoUniversity Hospital, Geneva
Study Responsible Party
Eduardo Schiffer, Principal Investigator, Professor, University Hospital, Geneva
Study Central Contact
Contact: Marc Pugliese, +41783061685, [email protected]
No location data.