Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions that can progress to significant fibrosis and cirrhosis. There are an estimated 40-90 million individuals within the United States with NAFLD, 10- 30% of whom have NASH and may develop NASH-related cirrhosis. Identifying through non- invasive means those individuals who are at risk for progressive liver disease remains challenging.
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 Adult Database 2 continued the longitudinal follow-up of participants enrolled in earlier NASH CRN studies and recruited new participants with recent liver biopsies. Comprehensive data, including demographics, medical history, symptoms, medication use, alcohol use and routine laboratory studies were collected on all participants at entry and at annual visits for up to 10 years after enrollment. A liver biopsy was collected at baseline if not collected in a prior NASH CRN study. Study questionnaires administered at enrollment included Skinner Lifetime Drinking history, Alcohol Use Disorders Identification Test (AUDIT) and Beverage Questionnaire (BEVQ-15).
Specimens were collected every 48 weeks during follow-up. If liver biopsies were obtained as part of routine patient care, they were scored using the NASH CRN NAFLD Activity Score (NAS) and fibrosis score. The Interim drinking history (AUDIT-C) and BEVQ-15 were collected at follow-up visits.
Primary objective(s): To further investigate the etiology, pathogenesis, natural history, diagnosis, treatment, and prevention of nonalcoholic fatty liver disease (NAFLD) and in particular its more severe form of NASH and understand disease variations occurring in an ethnically diverse group of patients.
Secondary objective(s): To provide a resource for developing clinical and pathological criteria for standardizing diagnostic and staging criteria for NAFLD or NASH-related cirrhosis through development of novel biomarkers and technologies such as genomics and innovative imaging technologies.
The primary and secondary objectives of the NAFLD Adult Database 2 were intentionally broad to answer expected unaswered questions related to the etiology, natural history, diagnosis, treatment, and prevention of NAFLD. The following measures were used to answer outcomes of interest: liver histology scores (from central reading of liver biopsy at entry, standard of care biopsy done during screening or follow-up, or liver biopsy obtained from previous NASH CRN study participation), glucose, insulin, ALT and AST levels, lipid profile, body mass index and anthropometric data, alcohol consumption data and medication use.
Inclusion criteria:
Exclusion criteria:
A total of 2501 participants (657 of which were continuing participants from prior NASH CRN studies) were included in the NAFLD Adult Database. Data collection began on October 5, 2009 and concluded on May 31, 2020. The histologic scoring system for review and grading of liver biopsies was further refined and expanded and FibroScan examinations implemented. A landmark manuscript was published on the clinical outcomes in adult patients with NAFLD.
Participants will continue to be followed in NAFLD Database 3 study (DB3), the third phase of the longitudinal NAFLD database study.
Liver Disease
Observational
2009-12
2020-05
Cirrhosis of Liver, Metabolic Dysfunction-Associated Steatohepatitis, Fibrotic Liver Disease, Fatty Liver Disease, Metabolic Dysfunction-Associated Steatotic Liver Disease
Cirrhosis, Non-Alcoholic Steatohepatitis, Nonalcoholic Fatty Liver Disease
DDN
Document Name | Description | Document Type | File Format |
---|---|---|---|
Dataset Name | Description | # of Records | # of Variables | File Format(s) |
---|---|---|---|---|
LS - Laboratory Results - Tests Done only During Screening (Revision 3) Data | Data collected to record archival and current results of laboratory tests done only during screening | 310 | sas7bdat (192 KB); csv (44.01 KB) | |
FR - FibroScan Report (Revision 2) Data | Data collected to record key information from the FibroScan exam | 209 | sas7bdat (128 KB); csv (14.74 KB) | |
CR - Central Histology Review (Revision 2) Data | Data collected to record results of the NASH CRN Pathology Committee review of liver biopsy slides archived at the Histology Review Center | 1137 | sas7bdat (192 KB); csv (93.63 KB) | |
IE - Interim Event Report (Revision 3) Data | Data collected to document events that occur after registration that impact on the patient’s participation in the NAFLD Database 2 Study (eg, mild or moderate liver biopsy complications). Complete this form if there has been an incident cirrhosis, hepatocellular carcinoma (HCC), hospitalization, Emergency Room visit, liver transplant, an event associated with a study-related procedure, or death | 335 | sas7bdat (128 KB); csv (25.21 KB) | |
LR - Laboratory Results - Tests Done During Screening and Follow-up (Revision 1) Data | Data collected to record archival and current laboratory test results for tests done during both screening and follow-up | 643 | sas7bdat (320 KB); csv (93.83 KB) | |
HC - Hepatocellular Carcinoma Report Data | Data collected to recorded the report of a patient's diagnosis of hepatocellular carcinoma (HCC) | 7 | sas7bdat (128 KB); csv (454 B) | |
CG - Genetic Consent and Blood Collection Documentation (Revision 1) Data | Data collected to document options selected for use of blood samples for genetic research | 1680 | sas7bdat (128 KB); csv (44.73 KB) | |
PE - Physical Examination Data | Data collected to record physical exam findings of NAFLD Database 2 patients | 9421 | sas7bdat (2.31 MB); csv (1.1 MB) | |
LS - Laboratory Results - Tests Done only During Screening (Revision 1) Data | Data collected to record archival and current results of laboratory tests done only during screening | 1635 | sas7bdat (576 KB); csv (183.38 KB) | |
LD - Lifetime Drinking History (Skinner) Data | Data collected to obtain quantitative indices of the patient's alcohol consumption patterns from the onset of regular drinking | 1690 | sas7bdat (704 KB); csv (416.43 KB) | |
DR - Death Report (Revision 2) Data | Data collected to record the report of a patient's death | 22 | sas7bdat (144 KB); csv (2.98 KB) | |
HI - Follow-Up Medical History Data | Data collected to record follow-up medical history information about the patient | 7154 | sas7bdat (3.81 MB); csv (1.99 MB) | |
FR - FibroScan Report (Revision 5) Data | Data collected to record key information from the FibroScan exam | 3352 | sas7bdat (640 KB); csv (290.87 KB) | |
BQ - Beverage Questionnaire (BEVQ-15) Data | Data collected to obtain the patient's beverage intake | 3634 | sas7bdat (384 KB); csv (268.45 KB) | |
FR - FibroScan Report (Revision 3) Data | Data collected to record key information from the FibroScan exam | 65 | sas7bdat (128 KB); csv (4.63 KB) | |
LS - Laboratory Results - Tests Done only During Screening (Revision 2) Data | Data collected to record archival and current results of laboratory tests done only during screening | 380 | sas7bdat (192 KB); csv (54.54 KB) | |
IE - Interim Event Report (Revision 2) Data | Data collected to document events that occur after registration that impact on the patient’s participation in the NAFLD Database 2 Study (eg, mild or moderate liver biopsy complications). Complete this form if there has been an incident cirrhosis, hepatocellular carcinoma (HCC), hospitalization, Emergency Room visit, liver transplant, an event associated with a study-related procedure, or death | 5 | sas7bdat (128 KB); csv (546 B) | |
RG - Registration Data | Data collected to register patients as candidates for enrollment in the NAFLD Database 2 study and to assign a patient ID number | 2325 | sas7bdat (576 KB); csv (158.28 KB) | |
LR - Laboratory Results - Tests Done During Screening and Follow-up (Revision 2) Data | Data collected to record archival and current laboratory test results for tests done during both screening and follow-up | 5150 | sas7bdat (1.63 MB); csv (772.69 KB) | |
FR - FibroScan Report (Revision 1) Data | Data collected to record key information from the FibroScan exam | 184 | sas7bdat (128 KB); csv (10.83 KB) | |
CR - Central Histology Review (Revision 3) Data | Data collected to record results of the NASH CRN Pathology Committee review of liver biopsy slides archived at the Histology Review Center | 1029 | sas7bdat (128 KB); csv (69.32 KB) | |
BG - Baseline History (Revision 1) Data | Data collected on baseline medical history information about the patient | 493 | sas7bdat (832 KB); csv (245.64 KB) | |
IR - Liver Imaging Studies Report Data | Data collected to record liver imaging results | 2916 | sas7bdat (1.56 MB); csv (290.71 KB) | |
DR - Death Report (Revision 1) Data | Data collected to record the report of a patient's death | 31 | sas7bdat (128 KB); csv (1.58 KB) | |
AD - Alcohol Use Disorders Identification Test (AUDIT) Data | Data collected to screen for current heavy drinking and/or active alcohol abuse or dependence | 2325 | sas7bdat (192 KB); csv (78.28 KB) | |
CV - Cardiovascular Risk Factors Data | Data collected to determine a patient's need for referral for cholesterol management based on the Adult Treatment Panel III cholesterol guidelines | 6382 | sas7bdat (896 KB); csv (721.73 KB) | |
CG - Genetic Consent and Blood Collection Documentation (Revision 2) Data | Data collected to document options selected for use of blood samples for genetic research | 684 | sas7bdat (128 KB); csv (19.43 KB) | |
CR - Central Histology Review (Revision 4) Data | Data collected to record results of the NASH CRN Pathology Committee review of liver biopsy slides archived at the Histology Review Center | 64 | sas7bdat (128 KB); csv (4.46 KB) | |
IE - Interim Event Report (Revision 1) Data | Data collected to document (1) events that occur after registration but before enrollment, or between regular follow-up visits, that impact on the patient’s participation in the NAFLD Database 2 Study (eg, mild or moderate liver biopsy complications), or (2) other event that clinical center staff feel should be reported now rather than wait until the next follow-up visit and that is not recorded on another NAFLD Database 2 form | 28 | sas7bdat (128 KB); csv (1.83 KB) | |
LR - Laboratory Results - Tests Done During Screening and Follow-up (Revision 3) Data | Data collected to record archival and current laboratory test results for tests done during both screening and follow-up | 3839 | sas7bdat (1.25 MB); csv (596.06 KB) | |
FR - FibroScan Report (Revision 4) Data | Data collected to record key information from the FibroScan exam | 1187 | sas7bdat (256 KB); csv (89.51 KB) | |
BG - Baseline History (Revision 2) Data | Data collected on baseline medical history information about the patient | 1832 | sas7bdat (2.53 MB); csv (906.78 KB) |
Specimen | Count |
---|---|
DNA | 427 |
Liver Tissue | 412 |
Plasma | 82775 |
Serum | 164484 |