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Nonalcoholic Fatty Liver Disease (NAFLD) Adult Database 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01030484
Recruitment Status : Recruiting
First Posted : December 11, 2009
Last Update Posted : March 13, 2019
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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
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

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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nonalcoholic Fatty Liver Disease (NAFLD) Adult Database 2
Actual Study Start Date : December 2, 2009
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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

Primary Outcome Measures :
  1. 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)

Biospecimen Retention:   Samples With DNA
plasma, serum, liver tissue

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01030484

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United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92103
Contact: Carolyn Hernandez    619-471-0774   
Principal Investigator: Rohit Loomba, MD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Claudia Ramos    415-502-2906   
Principal Investigator: Norah Terrault, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Linda Ragozzino    317-274-3514   
Principal Investigator: Naga Chalasani, MD         
United States, Missouri
St. Louis University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jacki Cerkoski    314-977-5239   
Contact: Rebecca Miller    (314) 977-9400   
Principal Investigator: Brent Tetri, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Mariko Kopping    919-684-4798   
Contact: Stephanie Buie    (919) 684-4138   
Principal Investigator: Anna Mae Diehl, MD         
Sub-Investigator: Manal Abdelmalek, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Jaspeet Reen    216-445-0688   
Contact: Annette Bellar    (216) 636-5247   
Principal Investigator: Arthur J McCullough, MD         
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Sherry Boyett    804-828-5434   
Contact: Jolene Schlosser    (804) 828-9195   
Principal Investigator: Arun J Sanyal, MD         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Sherilynn Soo    206-215-2980   
Contact: Michelle Poitevin    (206) 215-1729   
Principal Investigator: Kris Kowdley, MD         
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Study Director: Edward Doo, MD National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional Information:
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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Identifier: NCT01030484     History of Changes
Other Study ID Numbers: NAFLD Adult Database 2 (IND)
U01DK061730 ( U.S. NIH Grant/Contract )
First Posted: December 11, 2009    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: January 2019

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
non-alcoholic steatohepatitis
fatty liver disease

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases