NCT05903482

Brief Summary

Evaluating gastric volume in patients on GLP-1 RA medications

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

June 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

1.6 years

First QC Date

June 6, 2023

Last Update Submit

March 17, 2025

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Gastric volume in pediatric patients on GLP-1 RA

    A non-invasive, ultrasound will be performed to assess gastric volume. A second investigator not performing the ultrasound and blinded to whether the subject is taking a GLP-1 RA medication and whether the patient has diabetes and/or obesity will then assess the ultrasound images qualitatively for gastric contents (empty, clear liquids, solids) and quantitatively for gastric fluid volume if applicable.

    Day 1

Study Arms (3)

Diabetic, in GLP-1 RA

non-invasive, gastric ultrasound in children who are on GLP-1 RA medications and have type 2 diabetes mellitis (DM) and/or obesity and/or type 1 DM

Other: None - observational

Diabetic, not on GLP-1 RA

non-invasive, gastric ultrasound in children who are not on GLP-1 RA medications and have type 2 diabetes mellitis (DM) and/or obesity and/or type 1 DM.

Other: None - observational

Non-diabetic, not on GLP-1 RA

non-invasive, gastric ultrasound in non-diabetic children who are not on GLP-1 RA medications and do not have diabetes or obesity.

Other: None - observational

Interventions

None - observationalOTHER

Observational

Diabetic, in GLP-1 RADiabetic, not on GLP-1 RANon-diabetic, not on GLP-1 RA

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Fasting children on GLP-1 RA

You may qualify if:

  • Fasting Diabetic On GLP-1 RA

You may not qualify if:

  • Prior surgery that affects gastric anatomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19004, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Elaina Lin, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2023

First Posted

June 15, 2023

Study Start

June 6, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)