GLP_1 RA Ultrasound Study

NCT06581120 | Enrolling By Invitation

• 1 other identifier: 2024-0304
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine whether patients taking GLP-1 RAs have increased residual (left behind), gastric (stomach), contents due to delayed gastric emptying when following standard preoperative fasting guidelines.

Conditions

Glucagon Like Peptide-1 (GLP-1; Delayed Gastric Emptying; Risk of Aspiration; Diabetes; Morbid Obesity

Keywords

GLP-1; Glucagon like Peptide 1; Aspiration; Gastric empty

Outcome Measures

Primary Outcomes (1)

• Aspiration Risk determined by POGUS

  Difference between control group and GLP-1 group. Measured by Gastric contents during Point of Care Gastric Ultrasound.

  Two years

Study Arms (2)

GLP-1

Individuals currently taking glucagon like peptide receptors who have a surgery scheduled with Cincinnati Children's Hospital same day surgery endocrinology clinic and will receive a point of care gastric ultrasound.

Drug: Glucagon-Like Peptide-1 receptor agonists; Diagnostic Test: Point of Care Gastric Ultrasound

Control

Individuals not taking GLP-1 who have a surgery scheduled with Cincinnati Children's Hospital same day surgery or endocrinology clinic and will receive a point of care gastric ultrasound.

Diagnostic Test: Point of Care Gastric Ultrasound

Interventions

Glucagon-Like Peptide-1 receptor agonists DRUG

GLP-1 RAs: Glucagon like peptide-1 receptor agonists, this includes patients who are on Liraglutide, Semaglutide, Dulaglutide and Tirzepatide.Tirzepatide which is a combined GLP-1 RA/glucose-dependent insulinotropic polypeptide (GIP) agonist is included as a part of GLP-1 RAs.

GLP-1

Point of Care Gastric Ultrasound DIAGNOSTIC_TEST

A gastric ultrasound following a standard NPO period to determine gastric contents and risk of aspiration during surgery.

Also known as: POGUS

Control; GLP-1

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the endocrine clinic and from the preoperative surgical schedule.

You may qualify if:

• Body Mass Index over 35
• Type 2 Diabetes
• Currently taking GLP01 RA agonist (for GLP 1 group)
• Not taking GLP-1 RA agonist (for control group)

You may not qualify if:

• Diagnosis of gastroparesis
• patient refusal to participate
• Previous gastric bypass or any other gastric surgery
• Currently on peritoneal dialysis
• Abdominal pathology
• Gastro-intestinal obstruction
• Pregnancy

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital

Cincinnati, Ohio, 45299, United States

Location

MeSH Terms

Conditions

Gastroparesis; Diabetes Mellitus; Obesity, Morbid

Interventions

Glucagon-Like Peptide-1 Receptor Agonists

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight

Intervention Hierarchy (Ancestors)

Hypoglycemic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 3, 2024
• Study Start: July 8, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)