Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06355310
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-04-01
Brief Title:
Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease
Sponsor:
Ann Robert H Lurie Childrens Hospital of Chicago
Organization:
Ann Robert H Lurie Childrens Hospital of Chicago
Study Overview
Official Title:
Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHIELD
Brief Summary:
This study is a randomized double-blind placebo-controlled trial specifically designed to evaluate the preliminary feasibility initial efficacy and safety of SGLT2 inhibitors for treating NAFLD in adolescents with obesity
Detailed Description:
The overall aim of this pilot study is to evaluate the feasibility and obtain a preliminary estimate of efficacy and safety of the SGLT2 inhibitor empagliflozin in adolescents with obesity BMI-percentile 95th who have MRI-confirmed NAFLD hepatic fat fraction 55 and have normal fasting glucose
Participants will take empagliflozin once daily in the morning with or without food in addition to receiving lifestylebehavioral counseling throughout the study
The following data will be collected throughout the course of the study Physical exam with tanner staging safety and fasting labs fasting blood draw biomarkers urine sample 2-stage clamp overnight StayStable isotope tracers overnight Stay MRI scan MRS-Liver BMIanthropometrics urine pregnancy test for female participants iDXA scan body fat and bone density arterial stiffness and blood pressure
Participants will take empagliflozin once daily in the morning with or without food in addition to receiving lifestylebehavioral counseling throughout the study
The following data will be collected throughout the course of the study Physical exam with tanner staging safety and fasting labs fasting blood draw biomarkers urine sample 2-stage clamp overnight StayStable isotope tracers overnight Stay MRI scan MRS-Liver BMIanthropometrics urine pregnancy test for female participants iDXA scan body fat and bone density arterial stiffness and blood pressure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None