Nonalcoholic Fatty Liver Disease (NAFLD) Adult Database 2
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Liver Disease
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Enrollment
- 2501
- Locations
- 8
- Primary Endpoint
- Liver histology scores
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The NAFLD Database 2 will recruit at least 1,500 new adult participants suspected or known to have NAFLD or nonalcoholic steatohepatitis (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.
Detailed Description
To add to the existing NAFLD Database an additional 1,500 adult participants with a diagnosis of NAFLD, supported by a recent liver biopsy, with a broad range of severity. Core data collection will include clinical, demographic, laboratory, imaging, and histological features * To increase the population diversity of the NAFLD Database to provide greater representation of Hispanic, Native American, African American, and Asian patients among the new adult participants recruited into the NAFLD Database 2 * To expand the current specimen bank comprised of liver tissue, serum, plasma, and DNA obtained from new participants and continuing participants undergoing repeat liver biopsy with the specific goal of optimizing the collection of plasma or serum suitable for biomarker development studies by obtaining specimens in close temporal proximity to the performance of liver biopsy
Investigators
Eligibility Criteria
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)
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: Regular and excessive use of alcohol within the 2 years prior to interview defined as alcohol intake greater than 14 drinks per week in a man or greater than 7 drinks per week in a woman. Approximately 10 g of alcohol equals one 'drink' unit. One unit equals 1 ounce of distilled spirits, one 12-oz beer, or one 4-oz glass of wine
- •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. Liver biopsies obtained during bariatric surgery cannot be used for enrollment because of the associated surgical or anesthetic acute changes and the weight loss efforts that precede bariatric surgery
- •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 (participants with isolated antibody to hepatitis B core antigen, anti-HBc total, are not excluded)
- •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 (both determined at the discretion of the investigator)
Outcomes
Primary Outcomes
Liver histology scores
Time Frame: varies
Liver histology scores (derived from central reading of liver biopsy at entry, standard of care biopsy done during screening or follow-up, or liver biopsy obtained for PIVENS or TONIC trials)