GLP_1 RA Ultrasound Study

November 6, 2024 updated by: Children's Hospital Medical Center, Cincinnati

Assessment of Gastric Contents in Patients Taking Glucagon-Like Peptide-1 Receptor Agonists: a Prospective Observational Cross-sectional Study

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45299
        • Cincinnati Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Diagnostic test: Point of Care Gastric Ultrasound
A gastric ultrasound following a standard NPO period to determine gastric contents and risk of aspiration during surgery.
Other Names:
  • POGUS
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
A gastric ultrasound following a standard NPO period to determine gastric contents and risk of aspiration during surgery.
Other Names:
  • POGUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aspiration Risk determined by POGUS
Time Frame: Two years
Difference between control group and GLP-1 group. Measured by Gastric contents during Point of Care Gastric Ultrasound.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

August 29, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Estimated)

November 7, 2024

Last Update Submitted That Met QC Criteria

November 6, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0304

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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