Gastric EmptyingNCT07140289
Effect of Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) on Gastric Emptying
An observational study of Gastric Emptying and Glucagon-Like Peptide-1 Receptor Agonists, run by Wael Saasouh, MD at 1 site in United States.
Trial summary
This study aims to assess the effect of using Glucagon-like peptide-1 receptor agonists (GLP-1) receptor agonists on gastric emptying on surgical patients and whether specific guidelines need to be established for these patients. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Emptying, Glucagon-Like Peptide-1 Receptor Agonists, Intermittent Fasting
- What is being tested?
- Ultrasound of gastric contents
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 1 Jun 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Surgical patients undergoing procedures at the Detroit Medical Center
Who may be able to join
- Adult patients who are receiving Glucagon-like peptide-1 Receptor Agonist medication and scheduled for any elective surgery or procedure under anesthesia.
- The patient has provided informed consent for the study
Who cannot join
- Pregnant patients
- Patients with abnormal gastric anatomy like previous gastric resection or bypass( gastric band in situ, previous fundoplication, hiatus hernia
- Inability to consent
- Emergency surgery
- Cognitive impairment (due to the mixed reasons of potential misunderstanding of the aim of the study and inability to provide informed consent, potential inability to provide detailed fasting regimen before the surgery, potential for impaired use of GLP-1 agonists before the surgery)
- Terminal illness (due to the effect of chronic illness on the physiologic functions of gastrointestinal tract and gastric emptying)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) on Gastric Emptying Before Elective Surgery
This study aims to assess the effect of using Glucagon-like peptide-1 receptor agonists (GLP-1) receptor agonists on gastric emptying on surgical patients and whether specific guidelines need to be established for these patients. GLP-1 receptor agonists are mainly used for the treatment and mitigation of obesity and metabolic syndromes. One of their mechanisms of action is by delaying gastric emptying, hence increasing satiety. However, patients need to abstain from eating for a set amount of time before surgery to reduce the risk of aspiration. Hence patients who use GLP-1 receptor agonists may need more time to abstain eating (nil-per-os). In this study we aim to assess how much time is sufficient before surgery in these specific population of patients.
Read the detailed description
Diabetes is a global health issue. It is the leading cause of death and disability worldwide. More than 1.31 billion people are projected to have diabetes in the world by 2050. Similarly in the United States total prevalence of diabetes is projected to be around 21% of the US population by 2050. Glucagon-like peptide-1 receptor agonists (GLP-1 RA), alternatively referred to as incretin mimetics, or GLP-1 analogs, constitute a category of drugs utilized for the management of type 2 diabetes mellitus and also for obesity. Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are hormones known as incretin hormones. GIP hormones play a role in stimulating the release of insulin after consuming glucose, which is referred to as the incretin effect. However, in people with type 2 diabetes, this process can be diminished or absent. Pharmacological levels of GLP-1 can help restore insulin secretion in individuals with type 2 diabetes. The advantages of using this approach for treating type 2 diabetes include the slowing down of stomach emptying and the suppression of glucagon production from pancreatic alpha cells when blood sugar levels are high. Additionally, GLP-1 RAs have the potential to reduce the death of pancreatic beta cells (the cells responsible for producing insulin) while also encouraging their growth.
Recent literature have raised concerns about the potential of GLP-1 RA-induced delayed gastric emptying to heighten the risk of regurgitation and inhalation of stomach contents during instances of general anesthesia and profound sedation. The term "high-risk stomach" refers to gastric volume carrying a heightened pulmonary aspiration risk, typically defined as liquid content exceeding 1.5 ml/kg or the presence of solid matter, as commonly described in literature. Gastric ultrasound has been used as an important tool for assessing the gastric content and volume. Measurement of the antral cross-sectional area by ultrasound with subsequent calculation of gastric volume can determine the low risk or high-risk stomach accordingly (8.
In June 2023, the ASA (American Society of Anesthesiologists) released a consensus-based guideline regarding the preoperative management of patients using GLP-1 RA. The recommendation advised taking these medications either on the day before or on the day of the procedure. Patients on a weekly regimen were advised to suspend the drug for the entire week. Although there are general fasting recommendations for the general population, no fasting recommendations were provided for patients on GLP-1 RA due to insufficient supporting evidence.
This research aims to increase our understanding about the effect of use of GLP-1 RAs on gastrointestinal motility and gastric emptying. The results of this study may provide insight regarding acceptable timing of NPO (Non per oral) before surgical procedures to reduce the risk of aspiration and other related complications.
The following information will be obtained from the patients in their visit:
- Patient's identifying information
- Patient's age
- Patient's gender
- Patient's weight
- Time of last eating or drinking
- Consumed food in the last eating or drinking
- Duration of fasting
- Patient's procedure/surgery
- Medical history, including Previous gastric resection or bypass, Previous fundoplication, Gastric band in situ, Large hiatus hernia, Pregnancy, GERD
- Any relevant surgical history, history of substance use, and list of current medications
- Name of GLP-1 receptor agonist drug and its brand name
- Dose of the medication
- Dosing interval of the medication
- Route of administration of the medication
- Duration of use of the medication since the first dose
- Last time of drug administration
- Reason for continuing GLP-1 receptor Agonist drug, including diabetes, weight loss, etc
Gastric Ultrasound Finding reporting items:
- Whether the stomach is empty or not
- Whether the stomach has liquid content or not
- The right lateral antral cross-sectional area (CSA)
- Calculated gastric volume
- Whether the stomach has solid food
- Conditions
- Gastric Emptying, Glucagon-Like Peptide-1 Receptor Agonists, Intermittent Fasting, Intraoperative Complication Due to Anesthesia, Respiratory Aspiration of Gastric Contents
- Being tested
- Ultrasound of gastric contents
- Medical subject headings
- Intermittent Fasting, Respiratory Aspiration of Gastric Contents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound of gastric contentsDiagnostic test
An ultrasound examination of the abdomen to observe and measure gastric contents
| Study group | Role | What they receive |
|---|---|---|
| Study group | Adult patients who are receiving a Glucagon-like peptide-1 Receptor Agonist and scheduled for any elective surgery or procedure under anesthesia. Receives: Diagnostic Test: Ultrasound of gastric contents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric cross-sectional area
Ultrasound measurement of the right- lateral cross-sectional area measurement of the gastric antrum measured pre-operatively
Measured: Preoperatively on the day of surgery (between admission to preoperative testing and start of surgical procedure).
Secondary outcomes (11)
Incidence of Pulmonary Aspiration
Documented clinical evidence of aspiration (e.g., witnessed event, presence of aspirated material in airway, or new infiltrate on chest imaging consistent with aspiration)
Measured: Between induction of anesthesia and discharge (up to 4 hours) from the post-anesthesia care unit after surgery
Incidence of Aspiration Pneumonia/Pneumonitis
Diagnosis based on clinical criteria (fever, leukocytosis, new infiltrate on chest X-ray, hypoxemia) and/or microbiological confirmation
Measured: Within 7 days of surgery (if data is available)
Incidence of other Respiratory Complications
New or worsening respiratory disease (e.g., ARDS, acute respiratory failure, need for escalation of ventilatory support)
Measured: Within 7 days of surgery (if data is available)
Need for Reintubation
Requirement for repeat endotracheal intubation due to respiratory compromise attributed to aspiration
Measured: Within 7 days of surgery (if data is available)
ICU Length of Stay
Number of days in ICU following aspiration event (up to 30 days)
Measured: Up to hospital discharge (up to 30 Days)
Hospital Length of Stay
Number of days in hospital following aspiration event
Measured: Up to 30 days
Mortality
All-cause mortality within 30 days of aspiration event
Measured: Within 30 days of surgery (if data is available)
Other Medical Complications
New onset infection (e.g., sepsis), fever, or other systemic complications following aspiration
Measured: Within 7 days of surgery (if data is available)
Hypoxemia
Oxygen saturation <90% requiring intervention (supplemental O₂, airway support)
Measured: Between emergence from anesthesia and discharge from the post-anesthesia care unit after surgery
Reintubation or Unplanned Airway Intervention
Requirement for repeat endotracheal intubation or advanced airway management due to respiratory compromise attributed to aspiration
Measured: Within 7 days of surgery (if data is available)
Postoperative Anesthetic Respiratory Complications
Composite of events including laryngospasm, bronchospasm, upper airway obstruction, or need for noninvasive ventilation
Measured: Between emergence from anesthesia and discharge from the post-anesthesia care unit after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Sep 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric EmptyingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Wael Saasouh, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Wayne State University
- Responsible party
- Sponsor-investigator, Wael Saasouh, MD, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140289
- Sponsor's protocol ID
- IRB 23-10-6273
- Status last verified
- Jul 2026
- First submitted
- 18 Aug 2025
- Last updated
- 16 Jul 2026
- 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) on Gastric Emptying Before Elective Surgery
- ClinicalTrials.gov ID
- NCT07140289
- Acronym / sponsor ID
- IRB 23-10-6273
- Conditions
- Gastric Emptying, Glucagon-Like Peptide-1 Receptor Agonists, Intermittent Fasting, Intraoperative Complication Due to Anesthesia, Respiratory Aspiration of Gastric Contents
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wael Saasouh, MDUniversity, hospital or other
- Collaborators
- Wayne State University
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 24 Aug 2025 (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.
This study aims to assess the effect of using Glucagon-like peptide-1 receptor agonists (GLP-1) receptor agonists on gastric emptying on surgical patients and whether specific guidelines need to be established for these patients. GLP-1 receptor agonists are mainly used for the treatment and mitigation of obesity and metabolic syndromes. One of their mechanisms of action is by delaying gastric emptying, hence increasing satiety. However, patients need to abstain from eating for a set amount of time before surgery to reduce the risk of aspiration. Hence patients who use GLP-1 receptor agonists may need more time to abstain eating (nil-per-os). In this study we aim to assess how much time is sufficient before surgery in these specific population of patients.
Detailed description
Diabetes is a global health issue. It is the leading cause of death and disability worldwide. More than 1.31 billion people are projected to have diabetes in the world by 2050. Similarly in the United States total prevalence of diabetes is projected to be around 21% of the US population by 2050. Glucagon-like peptide-1 receptor agonists (GLP-1 RA), alternatively referred to as incretin mimetics, or GLP-1 analogs, constitute a category of drugs utilized for the management of type 2 diabetes mellitus and also for obesity. Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are hormones known as incretin hormones. GIP hormones play a role in stimulating the release of insulin after consuming glucose, which is referred to as the incretin effect. However, in people with type 2 diabetes, this process can be diminished or absent. Pharmacological levels of GLP-1 can help restore insulin secretion in individuals with type 2 diabetes. The advantages of using this approach for treating type 2 diabetes include the slowing down of stomach emptying and the suppression of glucagon production from pancreatic alpha cells when blood sugar levels are high. Additionally, GLP-1 RAs have the potential to reduce the death of pancreatic beta cells (the cells responsible for producing insulin) while also encouraging their growth.
Recent literature have raised concerns about the potential of GLP-1 RA-induced delayed gastric emptying to heighten the risk of regurgitation and inhalation of stomach contents during instances of general anesthesia and profound sedation. The term "high-risk stomach" refers to gastric volume carrying a heightened pulmonary aspiration risk, typically defined as liquid content exceeding 1.5 ml/kg or the presence of solid matter, as commonly described in literature. Gastric ultrasound has been used as an important tool for assessing the gastric content and volume. Measurement of the antral cross-sectional area by ultrasound with subsequent calculation of gastric volume can determine the low risk or high-risk stomach accordingly (8.
In June 2023, the ASA (American Society of Anesthesiologists) released a consensus-based guideline regarding the preoperative management of patients using GLP-1 RA. The recommendation advised taking these medications either on the day before or on the day of the procedure. Patients on a weekly regimen were advised to suspend the drug for the entire week. Although there are general fasting recommendations for the general population, no fasting recommendations were provided for patients on GLP-1 RA due to insufficient supporting evidence.
This research aims to increase our understanding about the effect of use of GLP-1 RAs on gastrointestinal motility and gastric emptying. The results of this study may provide insight regarding acceptable timing of NPO (Non per oral) before surgical procedures to reduce the risk of aspiration and other related complications.
The following information will be obtained from the patients in their visit:
- Patient's identifying information
- Patient's age
- Patient's gender
- Patient's weight
- Time of last eating or drinking
- Consumed food in the last eating or drinking
- Duration of fasting
- Patient's procedure/surgery
- Medical history, including Previous gastric resection or bypass, Previous fundoplication, Gastric band in situ, Large hiatus hernia, Pregnancy, GERD
- Any relevant surgical history, history of substance use, and list of current medications
- Name of GLP-1 receptor agonist drug and its brand name
- Dose of the medication
- Dosing interval of the medication
- Route of administration of the medication
- Duration of use of the medication since the first dose
- Last time of drug administration
- Reason for continuing GLP-1 receptor Agonist drug, including diabetes, weight loss, etc
Gastric Ultrasound Finding reporting items:
- Whether the stomach is empty or not
- Whether the stomach has liquid content or not
- The right lateral antral cross-sectional area (CSA)
- Calculated gastric volume
- Whether the stomach has solid food
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Ultrasound of gastric contentsAdult patients who are receiving a Glucagon-like peptide-1 Receptor Agonist and scheduled for any elective surgery or procedure under anesthesia. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical patients undergoing procedures at the Detroit Medical Center
Key inclusion criteria (2 listed)
- Adult patients who are receiving Glucagon-like peptide-1 Receptor Agonist medication and scheduled for any elective surgery or procedure under anesthesia.
- The patient has provided informed consent for the study
Key exclusion criteria (6 listed)
- Pregnant patients
- Patients with abnormal gastric anatomy like previous gastric resection or bypass( gastric band in situ, previous fundoplication, hiatus hernia
- Inability to consent
- Emergency surgery
- Cognitive impairment (due to the mixed reasons of potential misunderstanding of the aim of the study and inability to provide informed consent, potential inability to provide detailed fasting regimen before the surgery, potential for impaired use of GLP-1 agonists before the surgery)
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 |
|---|---|---|
| Ultrasound of gastric contentsAn ultrasound examination of the abdomen to observe and measure gastric contents | Diagnostic test | Study group |
Primary outcome
Gastric cross-sectional area
Time frame: Preoperatively on the day of surgery (between admission to preoperative testing and start of surgical procedure).
Ultrasound measurement of the right- lateral cross-sectional area measurement of the gastric antrum measured pre-operatively
11 secondary outcomes
Incidence of Pulmonary Aspiration
Time frame: Between induction of anesthesia and discharge (up to 4 hours) from the post-anesthesia care unit after surgery
Incidence of Aspiration Pneumonia/Pneumonitis
Time frame: Within 7 days of surgery (if data is available)
Incidence of other Respiratory Complications
Time frame: Within 7 days of surgery (if data is available)
Need for Reintubation
Time frame: Within 7 days of surgery (if data is available)
ICU Length of Stay
Time frame: Up to hospital discharge (up to 30 Days)
Hospital Length of Stay
Time frame: Up to 30 days
Mortality
Time frame: Within 30 days of surgery (if data is available)
Other Medical Complications
Time frame: Within 7 days of surgery (if data is available)
Hypoxemia
Time frame: Between emergence from anesthesia and discharge from the post-anesthesia care unit after surgery
Reintubation or Unplanned Airway Intervention
Time frame: Within 7 days of surgery (if data is available)
Postoperative Anesthetic Respiratory Complications
Time frame: Between emergence from anesthesia and discharge from the post-anesthesia care unit after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Emptying and Glucagon-Like Peptide-1 Receptor Agonists, run by Wael Saasouh, MD at 1 site in United States.
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 2 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 16 Jul 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Gastric cross-sectional area (time frame: Preoperatively on the day of surgery (between admission to preoperative testing and start of surgical procedure).). 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 16 Jul 2026.