GastroparesisGUSTNCT06292065
Gastric Ultrasound To Assess Gastric Contents In Patients On Semaglutide Therapy
A study testing Point-of-care gastric ultrasound in people with Gastroparesis, run by Nils Vlaeminck at 1 site in Belgium.
Trial summary
Glucagon-like peptide-1 (GLP-1) receptor agonists (GLP-1-RA) such as semaglutide (Ozempic™, Rybelsus™, Wegovy™) were first introduced as a therapeutic agent for type 2 diabetes mellitus but they are being increasingly used to target weight loss in obesity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Point-of-care gastric ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Apr 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (>=18 years old)
- Semaglutide therapy for any indication (type 2 diabetes or weight loss)
- Semaglutide therapy at any dose
- Semaglutide therapy with any route of administration
- Semaglutide therapy administered daily or weekly
- Semaglutide therapy at any time since initiation
Show all 12Show fewer
- Elective surgery of any kind for which general anaesthesia was planned preoperatively
- Adherence to current ASA recommendation regarding GLP-1-RA; i.e. holding semaglutide for 1 week if administered weekly or for 1 day if administered daily.
- Adherence to current ESAIC fasting guidelines; i.e. >2 hours for liquids and >6 hours for solid foods.
- Adults (>=18 years old)
- Elective surgery of any kind for which general anaesthesia was planned preoperatively
- Adherence to current ESAIC fasting guidelines; i.e. >2 hours for liquids and >6 hours for solid foods
Who cannot join
- Semaglutide not held in accordance with current ASA recommendation, i.e. held either longer or shorter than recommended.
- No adherence to current ESAIC fasting guideline
- Presence of a contra-indication to gastric ultrasound; i.e. previous gastric surgery (e.g. partial gastrectomy, gastric bypass) or hiatal hernias.
- Presence of comorbidities associated with delayed gastric emptying: scleroderma, systemic lupus erythematosus, hypothyroidism, Parkinson disease, cerebral palsy, and multiple sclerosis.
- Inability to assume the right lateral decubitus position
- Initial anaesthetic plan did not involve general anaesthesia, e.g. neuraxial or locoregional cases
Show all 12Show fewer
- Semaglutide or other GLP-1-RA therapy
- No adherence to current ESAIC fasting guideline
- Presence of a contra-indication to gastric ultrasound; i.e. previous gastric surgery (e.g. partial gastrectomy, gastric bypass) or hiatal hernias
- Presence of comorbidities associated with delayed gastric emptying: scleroderma, systemic lupus erythematosus, hypothyroidism, Parkinson disease, cerebral palsy, and multiple sclerosis
- Inability to assume the right lateral decubitus position
- Initial anaesthetic plan does not involve general anaesthesia, e.g. locoregional cases
Trial locations and contacts
1 site in 1 country.
About this study
Glucagon-like peptide-1 (GLP-1) receptor agonists (GLP-1-RA) such as semaglutide (Ozempic™, Rybelsus™, Wegovy™) 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.
Read more
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.
- Conditions
- Gastroparesis
- Being tested
- Point-of-care gastric ultrasound
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care gastric ultrasoundDiagnostic test
Using ultrasound to visualise the gastric antrum in supine position and right lateral decubitus.
| Study group | Role | What they receive |
|---|---|---|
| Gastric Ultrasound | Experimental | Gastric ultrasound will be performed shortly before induction; i.e. in the preoperative room. The exam will be performed by the treating anaesthetist experienced with gastric ultrasound. The gastric antrum will be visualised in supine position followed by a second visualisation of the antrum in right lateral decubitus. In the latter position the cross-sectional area of the antrum (RIGHT-LAT CSA) will be measured and used to calculate the gastric volume using the [VOLUME (ML) = 27.0 + 14.6 X RIGHT-LAT CSA - 1.28 X AGE] formula. The patient will be considered to have a full stomach or positive gastric ultrasound if solid gastric content is visible in any visualisation of the antrum or if calculated liquid gastric content exceeds 1.5 ml/kg of total body weight. Receives: Diagnostic Test: Point-of-care gastric ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of full stomach
The prevalence of a full stomach based on gastric ultrasound (solids visible in any visualisation or calculated liquid gastric content exceeding 1.5 ml/kg of total body weight) in patients taking semaglutide compared to controls
Measured: Immediately preoperatively
Secondary outcomes (27)
Frequency of changes to the anaesthetic plan
The frequency of changes to the anaesthetic plan (including postponement of surgery, change to locoregional or neuraxial technique, rapid sequence intubation, choice of airway, preoperative placement of nasogastric suctioning) after gastric ultrasound in semaglutide patients compared to controls
Measured: Immediately preoperatively
Calculated gastric content
The calculated gastric content (median) based on gastric ultrasound in semaglutide patients compared to controls.
Measured: Immediately preoperatively
Prevalence of solid gastric content
The prevalence of solid gastric content visible on gastric ultrasound in semaglutide patients compared to controls
Measured: Immediately preoperatively
Association between fasting time for solids and 'full stomach'
The correlation between fasting time for solids and 'full stomach' on gastric ultrasound
Measured: Immediately preoperatively
Association between fasting time for liquids and 'full stomach'
The correlation between fasting time for liquids and 'full stomach' on gastric ultrasound
Measured: Immediately preoperatively
Frequency of perioperative aspiration
The frequency of perioperative aspiration of gastric contents in semaglutide patients compared to controls
Measured: Immediately postoperatively
Prevalence of gastric symptoms
The prevalence of gastric symptoms (nausea, vomiting, dyspepsia, abdominal distension) in semaglutide patients compared to controls
Measured: Immediately preoperatively
Association between nausea and 'full stomach'
The correlation between nausea and 'full stomach' on gastric ultrasound
Measured: Immediately preoperatively
Association between vomiting and 'full stomach'
The correlation between vomiting and 'full stomach' on gastric ultrasound
Measured: Immediately preoperatively
Association between dyspepsia and 'full stomach'
The correlation between dyspepsia and 'full stomach' on gastric ultrasound
Measured: Immediately preoperatively
Association between abdominal distension and 'full stomach'
The correlation between abdominal distension and 'full stomach' on gastric ultrasound
Measured: Immediately preoperatively
association between semaglutide dose and calculated gastric content
The correlation between semaglutide dose and calculated gastric content on gastric ultrasound
Measured: Immediately preoperatively
association between semaglutide dose and 'full stomach'
The correlation between semaglutide dose and 'full stomach' on gastric ultrasound
Measured: Immediately preoperatively
Association between frequency of semaglutide administration and calculated gastric content
The correlation between frequency of semaglutide administration and calculated gastric content on gastric ultrasound
Measured: Immediately preoperatively
Association between frequency of semaglutide administration and 'full stomach'
The correlation between frequency of semaglutide administration and 'full stomach' on gastric ultrasound
Measured: Immediately preoperatively
Association between duration of semaglutide therapy and calculated gastric content
The correlation between duration of semaglutide therapy and calculated gastric content on gastric ultrasound
Measured: Immediately preoperatively
Association between duration of semaglutide therapy at current dose and calculated gastric content
The correlation between duration of semaglutide therapy at current dose and calculated gastric content on gastric ultrasound
Measured: Immediately preoperatively
Association between duration of semaglutide therapy and 'full stomach'
The correlation between duration of semaglutide therapy and 'full stomach' on gastric ultrasound
Measured: Immediately preoperatively
Association between duration of semaglutide therapy at current dose and 'full stomach'
The correlation between duration of semaglutide therapy at current dose and 'full stomach' on gastric ultrasound
Measured: Immediately preoperatively
Association between duration of cessation of semaglutide and calculated gastric content
The correlation between duration of cessation of semaglutide therapy and calculated gastric content on gastric ultrasound in patients administering semaglutide daily and weekly
Measured: Immediately preoperatively
Association between duration of cessation of semaglutide and 'full stomach'
The correlation between duration of cessation of semaglutide therapy and 'full stomach' on gastric ultrasound in patients administering semaglutide daily and weekly
Measured: Immediately preoperatively
Association between preoperative blood glucose levels and calculated gastric content
The correlation between preoperative blood glucose levels and calculated gastric content on gastric ultrasound
Measured: Immediately preoperatively
Association between preoperative blood glucose levels and 'full stomach'
The correlation between preoperative blood glucose levels and 'full stomach' on gastric ultrasound
Measured: Immediately preoperatively
Association between HbA1c levels and calculated gastric content
The correlation between HbA1c levels and calculated gastric content on gastric ultrasound
Measured: Immediately preoperatively
Association between HbA1c levels and 'full stomach'
The correlation between HbA1c levels and 'full stomach' on gastric ultrasound
Measured: Immediately preoperatively
Association between time since onset of diabetes mellitus and calculated gastric content
The correlation between time since onset of diabetes mellitus and calculated gastric content on gastric ultrasound
Measured: Immediately preoperatively
Association between time since onset of diabetes mellitus and 'full stomach'
The correlation between time since onset of diabetes mellitus and 'full stomach' on gastric ultrasound
Measured: Immediately preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start16 Apr 2024
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 45 patients on semaglutide therapy will be included together with 45 age, BMI and diabetes status matched controls.
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nils Vlaeminck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nils Vlaeminck, University Hospital, Antwerp
- Investigators
- Nils Vlaeminck, MD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292065
- Sponsor's protocol ID
- Project ID 6171
- Acronym
- GUST
- Status last verified
- Aug 2025
- First submitted
- 23 Feb 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Ultrasound To Assess Gastric Contents In Patients On Semaglutide Therapy
- ClinicalTrials.gov ID
- NCT06292065
- Acronym / sponsor ID
- GUST / Project ID 6171
- Conditions
- Gastroparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Nils VlaeminckUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Glucagon-like peptide-1 (GLP-1) receptor agonists (GLP-1-RA) such as semaglutide (Ozempic™, Rybelsus™, Wegovy™) 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 45 patients on semaglutide therapy will be included together with 45 age, BMI and diabetes status matched controls.
| Arm | Type | Receives |
|---|---|---|
| Gastric Ultrasound | Experimental | Diagnostic Test: Point-of-care gastric ultrasoundGastric ultrasound will be performed shortly before induction; i.e. in the preoperative room. The exam will be performed by the treating anaesthetist experienced with gastric ultrasound. The gastric antrum will be visualised in supine position followed by a second visualisation of the antrum in right lateral decubitus. In the latter position the cross-sectional area of the antrum (RIGHT-LAT CSA) will be measured and used to calculate the gastric volume using the [VOLUME (ML) = 27.0 + 14.6 X RIGHT-LAT CSA - 1.28 X AGE] formula. The patient will be considered to have a full stomach or positive gastric ultrasound if solid gastric content is visible in any visualisation of the antrum or if calculated liquid gastric content exceeds 1.5 ml/kg of total body weight. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adults (>=18 years old)
- Semaglutide therapy for any indication (type 2 diabetes or weight loss)
- Semaglutide therapy at any dose
- Semaglutide therapy with any route of administration
- Semaglutide therapy administered daily or weekly
Key exclusion criteria (12 listed)
- Semaglutide not held in accordance with current ASA recommendation, i.e. held either longer or shorter than recommended.
- No adherence to current ESAIC fasting guideline
- Presence of a contra-indication to gastric ultrasound; i.e. previous gastric surgery (e.g. partial gastrectomy, gastric bypass) or hiatal hernias.
- Presence of comorbidities associated with delayed gastric emptying: scleroderma, systemic lupus erythematosus, hypothyroidism, Parkinson disease, cerebral palsy, and multiple sclerosis.
- Inability to assume the right lateral decubitus position
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-care gastric ultrasoundUsing ultrasound to visualise the gastric antrum in supine position and right lateral decubitus. | Diagnostic test | Gastric Ultrasound |
Primary outcome
Prevalence of full stomach
Time frame: Immediately preoperatively
The prevalence of a full stomach based on gastric ultrasound (solids visible in any visualisation or calculated liquid gastric content exceeding 1.5 ml/kg of total body weight) in patients taking semaglutide compared to controls
27 secondary outcomes
Frequency of changes to the anaesthetic plan
Time frame: Immediately preoperatively
Calculated gastric content
Time frame: Immediately preoperatively
Prevalence of solid gastric content
Time frame: Immediately preoperatively
Association between fasting time for solids and 'full stomach'
Time frame: Immediately preoperatively
Association between fasting time for liquids and 'full stomach'
Time frame: Immediately preoperatively
Frequency of perioperative aspiration
Time frame: Immediately postoperatively
Prevalence of gastric symptoms
Time frame: Immediately preoperatively
Association between nausea and 'full stomach'
Time frame: Immediately preoperatively
Association between vomiting and 'full stomach'
Time frame: Immediately preoperatively
Association between dyspepsia and 'full stomach'
Time frame: Immediately preoperatively
Association between abdominal distension and 'full stomach'
Time frame: Immediately preoperatively
association between semaglutide dose and calculated gastric content
Time frame: Immediately preoperatively
association between semaglutide dose and 'full stomach'
Time frame: Immediately preoperatively
Association between frequency of semaglutide administration and calculated gastric content
Time frame: Immediately preoperatively
Association between frequency of semaglutide administration and 'full stomach'
Time frame: Immediately preoperatively
Association between duration of semaglutide therapy and calculated gastric content
Time frame: Immediately preoperatively
Association between duration of semaglutide therapy at current dose and calculated gastric content
Time frame: Immediately preoperatively
Association between duration of semaglutide therapy and 'full stomach'
Time frame: Immediately preoperatively
Association between duration of semaglutide therapy at current dose and 'full stomach'
Time frame: Immediately preoperatively
Association between duration of cessation of semaglutide and calculated gastric content
Time frame: Immediately preoperatively
Association between duration of cessation of semaglutide and 'full stomach'
Time frame: Immediately preoperatively
Association between preoperative blood glucose levels and calculated gastric content
Time frame: Immediately preoperatively
Association between preoperative blood glucose levels and 'full stomach'
Time frame: Immediately preoperatively
Association between HbA1c levels and calculated gastric content
Time frame: Immediately preoperatively
Association between HbA1c levels and 'full stomach'
Time frame: Immediately preoperatively
Association between time since onset of diabetes mellitus and calculated gastric content
Time frame: Immediately preoperatively
Association between time since onset of diabetes mellitus and 'full stomach'
Time frame: Immediately preoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nils Vlaeminck, MD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-care gastric ultrasound in people with Gastroparesis, run by Nils Vlaeminck at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of full stomach (time frame: Immediately preoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.