Nonalcoholic Fatty Liver Disease (NAFLD) Adult Database 2

February 7, 2022 updated by: Johns Hopkins Bloomberg School of Public Health
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

2501

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92103
        • University of California, San Diego
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • St. Louis University
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult patients with suspected or known non-alcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH)-related cirrhosis of the liver

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
NAFLD
adult patients with non-alcoholic fatty liver disease (NAFLD).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
varies

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

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

Investigators

  • Study Director: Edward Doo, MD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2009

Primary Completion (Actual)

May 31, 2020

Study Completion (Actual)

May 31, 2020

Study Registration Dates

First Submitted

December 10, 2009

First Submitted That Met QC Criteria

December 10, 2009

First Posted (Estimate)

December 11, 2009

Study Record Updates

Last Update Posted (Actual)

February 23, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAFLD Adult Database 2 (IND)
  • U01DK061730 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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