Nonalcoholic Fatty Liver Disease (NAFLD) Adult Database 2



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:December 2, 2009
End Date:December 2019

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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.

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

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
We found this trial at
8
sites
5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: Kris Kowdley, MD
Phone: 206-215-2980
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Seattle, WA
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Naga Chalasani, MD
Phone: 317-274-3514
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Arthur J McCullough, MD
Phone: 216-445-0688
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Anna Mae Diehl, MD
Phone: 919-684-4798
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Rohit Loomba, MD
Phone: 619-471-0774
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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La Jolla, CA
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Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Arun J Sanyal, MD
Phone: 804-828-5434
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Richmond, VA
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Saint Louis, Missouri 63110
Principal Investigator: Brent Tetri, MD
Phone: 314-977-5239
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from
Saint Louis, MO
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San Francisco, California 94143
Principal Investigator: Norah Terrault, MD
Phone: 415-502-2906
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San Francisco, CA
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