GLP_1 RA Ultrasound Study

NCT ID: NCT06581120

Last Updated: 2024-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-08

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Glucagon-Like Peptide-1 receptor agonists

Intervention Type 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.

Point of Care Gastric Ultrasound

Intervention Type DIAGNOSTIC_TEST

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

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.

Point of Care Gastric Ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type DRUG

Point of Care Gastric Ultrasound

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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POGUS

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2024-0304

Identifier Type: -

Identifier Source: org_study_id

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