Inclusion Criteria
(Previously Enrolled in the NAFLD Database Study or TONIC Trial)
Age at least 2 years and not older than 17 years during the consent process
Willingness to continue to be followed for up to 4 years
Ability and willingness to give written, informed parental consent and child assent, per local IRB guidelines, to be enrolled into the pediatric Database 2 study
Minimal or no alcohol use history consistent with NAFLD
(New participants)
Age at least 2 years of age and not older than 17 years during the consent process
Willingness to be followed for up to 4 years
Ability and willingness to give written, informed parent consent and child assent to be enrolled into the pediatric
Minimal or no alcohol use history consistent with NAFLD
Having undergone a liver biopsy that is obtained within 120 days of enrollment
Collection of biosamples (serum, plasma, DNA, and, if available, liver tissue) within 90 days prior to enrollment and 0-90 days before or 4-90 days after the standard of care liver biopsy
Exclusion Criteria
Short bowel syndrome
History of gastric or jejunoileal bypass preceding the diagnosis of NAFLD
Known dysbetalipoproteinemia
Cystic fibrosis
Other metabolic or congenital liver disease
Evidence of systemic infectious disease
Known HIV positive
Disseminated or advanced malignancy
Concomitant severe underlying systemic illness that in the opinion of the investigator would interfere with completion of follow-up