Nonalcoholic Fatty Liver Disease (NAFLD) Adult Database 2

NCT01030484 | Completed DMC

• 2 other identifiers: NAFLD Adult Database 2 (IND)U01DK061730
• Study Type: observational
• Target: 2,501
• Locations: 1 country
• Sites: 8

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.

Conditions

Liver Disease

Keywords

NAFLD; NASH; non-alcoholic steatohepatitis; fatty liver disease

Outcome Measures

Primary Outcomes (1)

• Liver histology scores

  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

Study Arms (1)

NAFLD

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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 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)

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (8)

University of California, San Diego

La Jolla, California, 92103, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

St. Louis University

St Louis, Missouri, 63110, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (2)

• Sanyal AJ, Van Natta ML, Clark J, Neuschwander-Tetri BA, Diehl A, Dasarathy S, Loomba R, Chalasani N, Kowdley K, Hameed B, Wilson LA, Yates KP, Belt P, Lazo M, Kleiner DE, Behling C, Tonascia J; NASH Clinical Research Network (CRN). Prospective Study of Outcomes in Adults with Nonalcoholic Fatty Liver Disease. N Engl J Med. 2021 Oct 21;385(17):1559-1569. doi: 10.1056/NEJMoa2029349.

  PMID: 34670043 DERIVED

• Vilar-Gomez E, Gawrieh S, Liang T, McIntyre AD, Hegele RA, Chalasani N. Interrogation of selected genes influencing serum LDL-Cholesterol levels in patients with well characterized NAFLD. J Clin Lipidol. 2021 Mar-Apr;15(2):275-291. doi: 10.1016/j.jacl.2020.12.010. Epub 2020 Dec 27.

  PMID: 33454241 DERIVED

Related Links

• Nonalcoholic Steatohepatitis Clinical Research Consortium
• The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Biospecimen

Retention: SAMPLES WITH DNA

plasma, serum, liver tissue

MeSH Terms

Conditions

Liver Diseases; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fatty Liver

Study Officials

• Edward Doo, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 11, 2009
• Study Start: December 2, 2009
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: February 23, 2022

Record last verified: 2022-02

Locations

US (8)