Gastric Emptying in Healthy Volunteers and GLP-1 Agonist Users
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gastric Ultrasound.
- Who it may be relevant to
- Registry conditions: Diabetes Type 2, Obesity and Overweight. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Gastric Emptying Assessed by Gastric Ultrasound (US) in Healthy Volunteers and Semaglutide Users: Cohort Study
Overview
This observational study aims to determine the gastric emptying kinetics assessed by ultrasound in healthy volunteers after a standard breakfast and the state of the stomach after a clear liquid diet for 18 /24 hours in patients on GLP-1 agonist. The main questions it seeks to answer are: * Is the kinetic after a standard breakfast that includes ( avocado and eggs: high fat) as fast as a standard meal that does not involve this food? * Is a clear liquid diet of 18 to 24 hours enough to be an empty-stomach, assessed by Ultrasound in patients on GLP1 agonist? Participants will be asked to do: -A baseline Gastric US will be performed for healthy volunteers, and then they will have a standardized breakfast. An hourly or bihourly assessment will be done by the US.
Detailed description
GLP-1 analogues enhance insulin secretion from β-cells, reduce glucagon secretion, have an appetite-suppressing effect, and delay gastric emptying. This last effect may make standard preoperative fasting inadequate, compromising airway safety during elective surgery and increasing aspiration risk.
The main goal is to gather evidence to determine the optimal fasting period and dietary regimen to ensure safe outpatient surgery without increasing the risk of aspiration.Ultrasound gastric content assessment is a highly accessible, bedside, cost-free, and low-risk tool for anesthesiologists. The increased use of these drugs in surgical patients and the lack of international consensus on their discontinuation and fasting protocols before surgery necessitate further study. Our hypothesis is that GLP-1 analogue users (for weight loss or diabetes) have significantly slower gastric emptying, but a 24-hour liquid regimen may be sufficient to ensure an empty stomach and safe elective surgery.
Interventions
- Diagnostic test Gastric Ultrasound
A gastric ultrasound will be performed to determine the state of the stomach. Empty, clear fluids, solid, and in case of fluid, the amount of it ( using free tracing)
Primary outcome measures
- Number of patients with each Grade ( stomach content characteristics) according Perlas et al [Time frame: 24 hours tops since the starting of the clear fluid diet]
Secondary outcome measures (1)
- Area of the stomach in supine and in RLD assessed by ultrasound [Time frame: 24 hours tops since the starting of the clear fluid diet]
Eligibility criteria
Inclusion criteria
- 18 years old or older
- Healthy volunteers or semaglutide users
Exclusion criteria
- Bariatric surgery
- Hiatal hernia
- Impairment to give consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06987669 · ID1406 · 2024-100