The Prevalence of Nonalcoholic Fatty Liver Disease (NAFLD) Pediatric

Status Terminated

Clinical Trial Summary

The prevalence of liver steatosis, steatohepatitis, fibrosis, and hemosiderosis in overweight and obese US Military dependent pediatric patients using MR Elastography and Quantitative MRI

Clinical Trial Description

The purpose of this prospective study is to determine the prevalence NAFLD and of factors that have been associated with the diagnosis of fatty liver disease in overweight and obese children and adolescents and to determine the effectiveness of an intervention. In order to do this, we will also compare laboratory values and the ability/feasibility of new magnetic resonance technologies to first detect fatty liver disease and then to detect a difference in liver health between pediatric patients with a normal BMI and those with a BMI ≥85%. This study will consist of two phases and a reproducibility arm involving 19 voluntary subjects from Phase 1 and the control group. Phase I: Aim 1: To determine the prevalence and relative risk of liver fibrosis, steatosis, steatohepatitis and hemosiderosis in overweight and obese US Military dependents between ages 10 and 17 compared with normal weight controls using specialized MRI (LMS). Aim 2: To compare results between MRI-LMS and MRE and to determine feasibility of one versus the other technology. Aim 3: To compare liver health of controls and overweight/obese subjects to determine if there is a difference between groups. Aim 4: To test for various biomarkers that have been shown to have an association with NASH Phase II: Aim 1: To evaluate the effectiveness of a nine month intervention consisting of diet and exercise education on the maintenance or reduction of liver steatosis, steatohepatitis, and fibrosis. Aim 2: To establish whether early imaging can predict short-term clinical outcomes (eg development of pre-diabetes, worsening NAFLD, development of NASH, or a change in liver stiffness or fibrosis as measured by MRE and LMS, respectively). Reproducibility Arm Aim 1: To evaluate the consistency of the LMS/MRE data. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04284371
Study type	Observational
Source	The Geneva Foundation
Contact
Status	Terminated
Phase
Start date	February 10, 2016
Completion date	January 26, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Prevalence of Nonalcoholic Fatty Liver Disease (NAFLD) Pediatric Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms