Clinical trial NCT04284371: The Prevalence of Nonalcoholic Fatty Liver Disease (NAFLD) Pediatric Patients
Official title: 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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Steatohepatitis, Nonalcoholic
Hemosiderosis
Overweight Adolescents
Obesity, Childhood
Liver Steatosis
Keywords: Liver Steatosis
Overweight Adolescents
Lead sponsor: The Geneva Foundation
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 150
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Military dependent population male and females age 10-17 years of age

Brief 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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: LiverMultiScan (LMS)
timeFrame: 2 years
measure: MRE
timeFrame: 24
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Brooke Army Medical Center
name: Christian Carlosn, MD
role: PRINCIPAL_INVESTIGATOR
References: