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Gastric Ultrasound To Assess Gastric Contents In Patients On Semaglutide Therapy - Trial NCT06292065

Access comprehensive clinical trial information for NCT06292065 through Pure Global AI's free database. This phase not specified trial is sponsored by Nils Vlaeminck and is currently Not yet recruiting. The study focuses on Gastroparesis. Target enrollment is 90 participants.

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NCT06292065
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diagnostic test
Trial Details
ClinicalTrials.gov โ€ข NCT06292065
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Gastric Ultrasound To Assess Gastric Contents In Patients On Semaglutide Therapy

Study Focus

Gastroparesis

Point-of-care gastric ultrasound

Interventional

diagnostic test

Sponsor & Location

Nils Vlaeminck

University Hospital, Antwerp

Timeline & Enrollment

N/A

Mar 01, 2024

Dec 31, 2024

90 participants

Primary Outcome

Prevalence of full stomach

Summary

Glucagon-like peptide-1 (GLP-1) receptor agonists (GLP-1-RA) such as semaglutide (Ozempicโ„ข,
 Rybelsusโ„ข, Wegovyโ„ข) were first introduced as a therapeutic agent for type 2 diabetes mellitus
 but they are being increasingly used to target weight loss in obesity.
 
 One of the mechanisms by which weight loss is achieved, is increased satiety and
 significantly delayed gastric emptying. Tachyphylaxis for this effect has been reported with
 chronic use of long acting GLP-1-RA (e.g. semaglutide) but this was based on the paracetamol
 absorption technique or 13C breath test. Recent clinical data suggests semaglutide use does
 increase perioperative gastric content.This creates uncertainty for anaesthetists who are,
 anecdotally, more frequently faced with patients who may or may not have full stomachs
 despite adhering to conventional fasting guidelines.
 
 To address this issue the American Society of Anesthesiologists (ASA) has recently released
 guidelines in which it advises to hold GLP-1-RA for one day (if administered daily) or one
 week (if administered weekly).
 
 However, these recommendations are based on sparse empirical evidence and they do not
 necessarily follow from the known pharmacokinetic properties of these drugs. Typically,
 GLP-1-RA are administered in increasing doses over several weeks until a therapeutic steady
 state is achieved. Meanwhile the elimination half-life of e.g. semaglutide is 7 days. This
 means that holding semaglutide for one day or even one week might not be enough to attenuate
 its therapeutic effect of delayed gastric emptying. On the other hand if semaglutide were to
 be held for e.g. 5 terminal half-lifes, this would mean an unpractical 5 weeks during which
 glycemic control may be worsened and after which semaglutide doses would have to be
 incrementally increased again. Besides, hyperglycaemia secondary to semaglutide cessation can
 also delay gastric emptying.
 
 Further confounding the assessment of these patients there can be 'background' delayed
 gastric emptying in diabetic patients and more pronounced delayed gastric emptying in
 patients recently started on GLP-1-RA. The presence of gastro-intestinal symptoms (nausea,
 vomiting, dyspepsia, abdominal distension) might offer clinical information regarding
 increased gastric residue in this population.
 
 Gastric ultrasound is a point-of-care clinical and research tool that has steadily gained
 popularity to assess gastric content in patients not compliant with fasting rules or with
 certain comorbidities. Clinical decisions can be made based on the visualised content (e.g.
 solids, fluids or nothing) or through calculation of gastric volume by measuring antral
 circumference. In this study the investigators will examine gastric contents in patients who
 are taking semaglutide and in patients who are not. The investigators will then evaluate
 whether there is a difference in the incidence of full stomachs and whether gastric
 ultrasound influenced the anaesthetic plan of the treating anaesthetist.

ICD-10 Classifications

Attention to gastrostomy
Gastrostomy status
Other gastritis
Gastritis, unspecified
Gastric diverticulum

Data Source

ClinicalTrials.gov

NCT06292065

Non-Device Trial