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

The Prevalence of Liver Steatosis, Steatohepatitis, Fibrosis, and Hemosiderosis in Overweight and Obese US Military Dependent Pediatric Patients Using MR Elastography and Quantitative MRI

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

Study Overview

• Status: Terminated
• Conditions: Obesity, Childhood; Hemosiderosis; Liver Steatosis; Steatohepatitis, Nonalcoholic; Overweight Adolescents

Detailed 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 Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Brooke Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Military dependent population male and females age 10-17 years of age

Description

Inclusion Criteria:

1. DEERS eligible patients from the San Antonio Military Medical Center Healthy Habits clinic and pediatric endocrine, pediatric gastroenterology, adolescent, and general pediatric clinics, as well as from Wilford Hall's pediatric clinic.
2. Overweight (BMI > 85% and < (Control group) Normal BMI for age and gender (BMI <85%) 95% for age and gender) or obese (BMI >/= 95% for age and gender)
3. 10 - 17 years old
4. Cognitively able to understand and provide written informed assent
5. Written informed consent from parent or legal guardian

Exclusion criteria:

1. Current or prior history of liver disease (to include chronic hepatitis B or C, hemochromatosis, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, HIV, biliary atresia, or Caroli/choledochal disease), or other known liver disease.
2. Pregnancy (self-reported or through positive beta HCG test during study)
3. Current use of hepatotoxic medications associated with liver disease/failure (antifungals, methotrexate, valproic acid)
4. Carrying an implantable active medical device such as a pacemaker, vagal nerve stimulator, defibrillator, or non-MRI compatible cochlear implant.
5. Previous claustrophobia/anxiety with MRI scanner or developmental delays that may result in failed MRI scan (e.g.autism, anxiety disorder)
6. Any alcohol use
7. Predicted family PCS/loss of benefits in the next 9 months (Phase II only)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LiverMultiScan (LMS)	LMS Imagery will be used to for observance of the prevalence of liver fibrosis, steatosis, steatohepatitis and hemosiderosis on LMS in overweight and obese US Military dependents between ages 10 and 17	2 years
MRE	MRE imagery will be used as a comparison to the LMS imagery to help determine Liver stiffness as measured by MRE overweight and obese US Military dependents between ages 10 and 17after a 9 month intervention	24

Collaborators and Investigators

• Sponsor: The Geneva Foundation
• Investigators: Principal Investigator: Christian Carlosn, MD, Brooke Army Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2016
• Primary Completion (Actual): January 26, 2021
• Study Completion (Actual): January 26, 2021

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Liver Steatosis; Overweight Adolescents
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Liver Diseases; Overnutrition; Nutrition Disorders; Body Weight; Genetic Diseases, Inborn; Iron Metabolism Disorders; Metabolism, Inborn Errors; Obesity; Metal Metabolism, Inborn Errors; Iron Overload; Fatty Liver; Pediatric Obesity; Overweight; Non-alcoholic Fatty Liver Disease; Hemochromatosis; Hemosiderosis
• Other Study ID Numbers: C.2016.01

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