Nonalcoholic Fatty Liver Disease Pediatric Database 2

Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions associated with fat accumulation that range from benign, non-progressive liver fat accumulation to severe liver injury, cirrhosis, and liver failure. NAFLD is highly prevalent within the United States and is most common in adults who are overweight or have diabetes, insulin resistance, or hyperlipidemia. However, the disease also occurs in children and in persons who are not obese or diabetic. The Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) was initiated by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in 2002 to conduct multicenter, collaborative studies on the etiology, contributing factors, natural history, complications and treatment of NASH.

The NAFLD Pediatric Database 2 was a multicenter, prospective follow-up study of patients with NAFLD or nonalcoholic steatohepatitis (NASH) which aimed to investigate the etiology, pathogenesis, natural history, diagnosis, treatment, and prevention of NAFLD and NASH. The study included longitudinal follow-up of participants enrolled in earlier NASH CRN studies and recruited new participants. The study population included pediatric patients 2- 17 years old at the time of enrollment with histologically confirmed NAFLD or NASH located in the United States. Comprehensive data, including demographics, medical history, symptoms, medication use, alcohol use and routine laboratory studies was collected on all participants at entry and at follow-up visits every 48 weeks from enrollment. A standard of care liver biopsy was collected at baseline if not previously collected, and specimens were collected every 48 weeks during follow-up.