Investigation of the Evolution of Gastric Emptying by Gastric Ultra Sonography in Patients Treated With GLP-1 Receptor Agonists on a 7 Days Pausing Period.

NCT06388213 | Not Yet Recruiting FDA Device

• 1 other identifier: GLP-1 RA patients GE by GUS
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Glucagon-like-peptide-1 is a hormone released by the gut enteroendocrine cells. Its secretion occurs after each meal to enable production of insulin and inhibits the production of glucagon to lower after meal glycemia. It also inhibits gastric emptying and food intake. GLP-1 RA plays a role on GLP-1 receptors present on islet beta cells and delta cells of the pancreas to control insulin. GLP-1 receptors are also present in multiple region of the central nervous system such as the hypothalamus and hindbrain where it results in reducing food intake. For anesthesiologist it is important to understand how GLP-1 RA influence gastric emptying. Indeed, respecting a fasting period (6 hours for solid and 2 hours for liquid) before each surgery is one of the cornerstones of anesthesiology to significantly reduce the risk of pulmonary aspiration. One of the side effects of GLP-1 RA is slowing gastric emptying and increasing the risk of regurgitation in patient that observed a recommended fasting period. During 2023 a lot of cases reports have emerged of pulmonary aspiration or the presence of a full stomach in patient treated by GLP-1 RA for a type 2 diabetes. Despite recommendations made by the American Society of Anesthesiology, it is still unkown what is the best fasting period and how long patients should pause a long acting GLP-1 RA before surgery. In this observational study, we would like to determine the effect of GLP-1 RA on gastric emptying in patient scheduled for general anesthesia. We will measure and compare residual gastric content with gastric ultrasonography in patients treated by GLP-1 RA and in those who are not. We will also do these comparisons in a group of patients with type 2 diabetes treated by weekly GLP-1 RA at different days after the injection of the medication. Our hypothesis is that we will observe a reduction in gastric residue in patients who stopped weekly GLP-1 RA 7 days prior the examination compared to those who have stopped less days considering the same fasting period. This would lead us to propose an optimal duration of stopping time for GLP-1 inhibitors in the preoperative period.

Conditions

Diabetes Mellitus, Type 2; Anesthesia; Pulmonary Aspiration of Gastric Contents

Keywords

Glucagon Like Peptide 1 Receptors Agonists; Gastric Emptying; Gastric Ultrasound

Outcome Measures

Primary Outcomes (1)

• Change of antral cross sectional area in patients pausing 7 days GLP-1 RA treatment.

  7 days

Secondary Outcomes (1)

• Time course of change in gastric volume

  7 days

Study Arms (2)

Non GLP-1 RA group

Patient aged 18 years or older in healthy condition with no gastroparetic treatment and without history of gastro-intestinal pathology, respecting fasting period of 6 hours for solid or thick liquid (juice, milk, sparkling water and soda) and 2 hours for clear liquid (still water, black coffee or tea).

Device: Gastric Ultrasonography

GLP-1 RA group

Patients aged 18 years or older, treated with GLP-1 receptor agonists, respecting fasting period of 6 hours for solid or thick liquid (juice, milk, sparkling water and soda) and 2 hours for clear liquid (still water, black coffee or tea).

Device: Gastric Ultrasonography

Interventions

Gastric Ultrasonography DEVICE

Evaluation of cross sectional area of the antrum by gastric ultrasonography in healthy patients and in patient treated by GLP-1 receptor agonists after a fasting period (6 hours for solid and 2 hours for clear liquids). For the GLP-1 receptor agonists group the gastric ultrasonochography will be repeated each 2 days during 7 days. In the non GLP-1 receptors agonists group the evaluation will be executed one time.

GLP-1 RA group; Non GLP-1 RA group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with type 2 diabetes treated by an GLP-1 receptors agonists

You may qualify if:

• Patients over 18yrs old treated with GLP-1 receptor agonists for at least three months

You may not qualify if:

• Patients known for gastrointestinal motility disorders, history of gastric surgery, large hiatal hernia, or inability to lie in the right lateral decubitus position.

Sponsors & Collaborators

• University Hospital, Geneva: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Respiratory Aspiration of Gastric Contents

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Laryngopharyngeal Reflux; Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Respiratory Aspiration; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marc Pugliese

CONTACT

+41783061685; marc.pugliese@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 29, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: May 1, 2026
• Last Updated: May 1, 2024

Record last verified: 2024-04