An observational study in Gastric Emptying, Glucagon-Like Peptide-1 Receptor Agonists and Intermittent Fasting, sponsored by Wael Saasouh, MD. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Wael Saasouh, MD · Observational
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.
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:
Gastric Ultrasound Finding reporting items:
333 studies on the registry are indexed under Intermittent Fasting; 99 are open to participants now.
This study's planned enrollment of 100 is above the median of 67 across 12 observational studies indexed under Intermittent Fasting.
Browse Intermittent Fasting studies →This is the only study on the registry with Wael Saasouh, MD as lead sponsor.
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Surgical patients undergoing procedures at the Detroit Medical Center
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients who are receiving a Glucagon-like peptide-1 Receptor Agonist and scheduled for any elective surgery or procedure under anesthesia.
Diagnostic Test: Ultrasound of gastric contents
An ultrasound examination of the abdomen to observe and measure gastric contents
Gastric cross-sectional area
Ultrasound measurement of the right- lateral cross-sectional area measurement of the gastric antrum measured pre-operatively
Time frame: Preoperatively on the day of surgery (between admission to preoperative testing and start of surgical procedure).
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)
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
Diagnosis based on clinical criteria (fever, leukocytosis, new infiltrate on chest X-ray, hypoxemia) and/or microbiological confirmation
Time frame: 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)
Time frame: Within 7 days of surgery (if data is available)
Need for Reintubation
Requirement for repeat endotracheal intubation due to respiratory compromise attributed to aspiration
Time frame: 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)
Time frame: Up to hospital discharge (up to 30 Days)
Hospital Length of Stay
Number of days in hospital following aspiration event
Time frame: Up to 30 days
Mortality
All-cause mortality within 30 days of aspiration event
Time frame: 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
Time frame: Within 7 days of surgery (if data is available)
Hypoxemia
Oxygen saturation \<90% requiring intervention (supplemental O₂, airway support)
Time frame: 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
Time frame: 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
Time frame: Between emergence from anesthesia and discharge from the post-anesthesia care unit after surgery
Plan to share: No
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