Nonalcoholic Fatty Liver Disease (NAFLD) Adult Database 2

Sponsor

Johns Hopkins Bloomberg School of Public Health (Other)

Overall Status

Completed

CT.gov ID

NCT01030484

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

2,501

Enrollment

Locations

125.9

Actual Duration (Months)

312.6

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Disease

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

Study Design

Study Type:

Observational

Actual Enrollment :

2501 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Nonalcoholic Fatty Liver Disease (NAFLD) Adult Database 2

Actual Study Start Date :

Dec 2, 2009

Actual Primary Completion Date :

May 31, 2020

Actual Study Completion Date :

May 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
NAFLD adult patients with non-alcoholic fatty liver disease (NAFLD).

Outcome Measures

Primary Outcome Measures

Liver histology scores [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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: 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)
Wilson's disease
Known glycogen storage disease
Known dysbetalipoproteinemia
Known phenotypic hemochromatosis (HII greater than 1.9 or removal of more than 4 g of iron by phlebotomy)
Prominent bile duct injury (florid duct lesions or periductal sclerosis) 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Diego	La Jolla	California	United States	92103
2	University of California, San Francisco	San Francisco	California	United States	94143
3	Indiana University	Indianapolis	Indiana	United States	46202
4	St. Louis University	Saint Louis	Missouri	United States	63110
5	Duke University Medical Center	Durham	North Carolina	United States	27710
6	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
7	Virginia Commonwealth University	Richmond	Virginia	United States	23298
8	Swedish Medical Center	Seattle	Washington	United States	98104