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NAFLD Pediatric Database 2 (NAFLD Peds DB2)

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: NCT01061684
Recruitment Status : Recruiting
First Posted : February 3, 2010
Last Update Posted : March 14, 2018
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 650 new pediatric participants with liver biopsies and contemporaneous biosamples, and will also invite pediatric participants from the prior NAFLD Database and TONIC trial (50 with a recent biopsy and 150 without a contemporaneous biopsy) to enroll in the NAFLD Pediatric Database 2 study. Combining the new and continuing participants leads to a recruitment goal for the pediatric Database 2 of 850 pediatric participants during the enrollment period.

Condition or disease
Liver Disease

Detailed Description:
All the new pediatric participants will have had a liver biopsy within 120 days prior to enrollment coupled with contemporaneous biosamples within 90 days prior to enrollment and up to 90 days before or 4-90 days after the biopsy. We estimate that at least 50 of the continuing pediatric participants will be due for a standard of care liver biopsy at the time of their enrollment into the pediatric Database 2 study, and will, as a result, also have a liver biopsy and contemporaneous biosamples.

Study Type : Observational
Estimated Enrollment : 850 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nonalcoholic Fatty Liver Disease (NAFLD) Pediatric Database 2
Study Start Date : December 2009
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

pediatric 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 the TONIC trial)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants at least 2 years of age and less than 18 years of age with known or suspected NAFLD or NASH-related cirrhosis

Inclusion Criteria:

  • Continuing participants:

    • Previously enrolled in the NAFLD Database study or TONIC trial
    • Age at least 2 years and not older than 17 years during the consent process
    • Willingness to continue to be followed for up to 4 years
    • Ability and willingness to give written, informed parental consent and child assent, per local IRB guidelines, to be enrolled into the pediatric Database 2 study
  • New participants:

    • Age at least 2 years of age and not older than 17 years during the consent process
    • Willingness to be followed for up to 4 years
    • Ability and willingness to give written, informed parent consent and child assent to be enrolled into the pediatric Database 2 study
    • Minimal or no alcohol use history consistent with NAFLD
    • Having undergone a 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:

  • 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
  • Cystic 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 of study
  • Inability for parent to provide informed consent and child 8 years or greater to give assent

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): NCT01061684

United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92103
Contact: Janis Durelle    619-543-5226   
Principal Investigator: Jeffrey Schwimmer, MD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Camille Langlois    415-476-1756   
Principal Investigator: Philip Rosenthal, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Rebecca Cleeton    404-727-5383   
Contact: Jessica Cruz Munos    (404) 373-1360   
Principal Investigator: Saul Karpen, MD         
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago (NWU) Recruiting
Chicago, Illinois, United States, 60614
Contact: Joy Ito    312-227-4559   
Principal Investigator: Mark Fishbein, MD         
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Laura Walker, RN    317-944-4490   
Contact: Linda Ragozzi, RN    (317) 274-3514   
Principal Investigator: Jean Molleston, MD         
United States, Maryland
Johns Hopkins University Active, not recruiting
Baltimore, Maryland, United States, 21205
United States, Missouri
St. Louis University Recruiting
Saint Louis, Missouri, United States, 63104
Contact: Rebecca Miller    314-977-9400   
Contact: Jacki Cerkowski    (314) 977-5239   
Sub-Investigator: Adjay Jain, MD         
United States, New York
University at Buffalo-Women and Children's Hospital of Buffalo Recruiting
Buffalo, New York, United States, 14222
Contact: Sonja Williams    716-878-7391   
Sub-Investigator: Susan Baker, MD         
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Elena Reynosa, MD    212-305-6274   
Principal Investigator: Joel Lavine, MD, PhD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229-3039
Contact: Kimberlee Bernstein    513-636-4406   
Principal Investigator: Stavra Xanthakos, MD         
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Alicia Lawson, MD    832-824-3848   
Contact: Cynthia Tsai    (832) 822-3634   
Principal Investigator: Tamir Miloh, MD         
United States, Washington
Seattle Children's Hospital- UW Active, not recruiting
Seattle, Washington, United States, 98105
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Director: Ed Doo, MD National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Identifier: NCT01061684     History of Changes
Other Study ID Numbers: NAFLD Pediatric Database 2
U01DK061730 ( U.S. NIH Grant/Contract )
First Posted: February 3, 2010    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be uploaded to at the end of the funding.

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

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