Effect of Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) on Gastric Emptying

NCT07140289 | Enrolling By Invitation

• 1 other identifier: IRB 23-10-6273
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Gastric Emptying; Glucagon-Like Peptide-1 Receptor Agonists; Intermittent Fasting; Intraoperative Complication Due to Anesthesia; Respiratory Aspiration of Gastric Contents

Outcome Measures

Primary Outcomes (1)

• Gastric cross-sectional area

  Ultrasound measurement of the right- lateral cross-sectional area measurement of the gastric antrum measured pre-operatively

  Preoperatively on the day of surgery (between admission to preoperative testing and start of surgical procedure).

Secondary Outcomes (11)

• Incidence of Pulmonary Aspiration

  Between induction of anesthesia and discharge (up to 4 hours) from the post-anesthesia care unit after surgery

• Incidence of Aspiration Pneumonia/Pneumonitis

  Within 7 days of surgery (if data is available)

• Incidence of other Respiratory Complications

  Within 7 days of surgery (if data is available)

• Need for Reintubation

  Within 7 days of surgery (if data is available)

• ICU Length of Stay

  Up to hospital discharge (up to 30 Days)

Study Arms (1)

Study group

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

Interventions

Ultrasound of gastric contents DIAGNOSTIC_TEST

An ultrasound examination of the abdomen to observe and measure gastric contents

Study group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Surgical patients undergoing procedures at the Detroit Medical Center

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wael Saasouh, MD: lead
• Wayne State University: collaborator

Study Sites (1)

Detroit Medical Center

Detroit, Michigan, 482001, United States

Location

MeSH Terms

Conditions

Intermittent Fasting; Respiratory Aspiration of Gastric Contents

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Research, Dept of Anesthesiology WSU-DMC

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)