SHS_610038 KOWK FNIH 14135

Nonalcoholic Fatty Liver Disease (NAFLD) Adult Database 2

The NAFLD Database 2 will recruit at least 1,500 new adult participants suspected or known to have NAFLD or NASH-related cirrhosis and will also invite adult participants from the prior NAFLD Database and related studies (PIVENS trial and TONIC trial) to enroll in the NAFLD Database 2. To elucidate, through the cooperative effort of a multidisciplinary and multicenter group of collaborators, the etiology, natural history, diagnosis, treatment, and prevention of NAFLD, and in particular its more severe form of NASH and its complications.

Inclusion Criteria:

Continuing participants:
Previously enrolled in the NAFLD Database study, PIVENS or TONIC trials
Age at least 18 years during the consent process
Willingness to continue to be followed for up to 4 years
Ability and willingness to give written, informed consent to be enrolled into Database 2

New participants:
Age at least 18 years during the consent process
Willingness to be followed for up to 4 years
Ability and willingness to give written, informed consent to be screened for and, if eligible, to be enrolled into the Database 2 study
Minimal or no alcohol use history consistent with NAFLD (see exclusion criteria)
Collection of a standard of care 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:

Any condition or circumstances, which, in the opinion of the investigator, would interfere with completion of scheduled follow-up visits and procedures for the duration of the Database 2 study
Clinical or histological evidence of alcoholic liver disease
Total parenteral nutrition for more than 1 month within a 6 month period before baseline liver biopsy
Short bowel syndrome
History of gastric or jejunoileal bypass preceding the diagnosis of NAFLD; bariatric surgery performed following enrollment is not exclusionary
History of biliopancreatic diversion
Evidence of advanced liver disease defined as a Child-Pugh-Turcotte score equal to or greater than 10
Evidence of chronic hepatitis B as marked by the presence of HBsAg in serum
Evidence of chronic hepatitis C as marked by the presence of anti-HCV or HCV RNA in serum
Low alpha-1-antitrypsin level and ZZ phenotype (determined at the discretion of the investigator)
Wilson's disease
Known glycogen storage disease
Known dysbetalipoproteinemia
Known phenotypic hemochromatosis
Prominent bile duct injury or bile duct paucity
Chronic cholestasis
Vascular lesions (vasculitis, cardiac sclerosis, acute or chronic Budd-Chiari, hepatoportal sclerosis, peliosis)
Iron overload greater than 3+
Zones of confluent necrosis, infarction, massive or sub-massive, pan-acinar necrosis
Multiple epithelioid granulomas
Congenital hepatic fibrosis
Polycystic liver disease
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
Active drug use or dependence that, in the opinion of the study investigator, would interfere with adherence to study requirements
Any other condition, which in the opinion of the investigator would impede compliance or hinder completion
N/A
NCT01030484
All Other
Hepatic
Kris Kowdley, M.D.
NIH (National Institutes of Health)
  • Swedish Medical Center