Summary

Eligibility
for people ages 2 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Rohit Loomba, MDJeffrey Schwimmer, MD
Photo of Rohit Loomba
Rohit Loomba

Description

Summary

The NAFLD Database 3 will enroll approximately 1500 adult patients and 750 pediatric patients suspected or known to have NAFLD or NASH-related cirrhosis. 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.

Details

  • To enroll at least 2250 patients (1500 adult patients and 750 pediatric patients) with a diagnosis of NAFLD, supported by a standard of care 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 2 to provide greater representation of Hispanic, Native American, African American, and Asian patients recruited into the NAFLD Database 3
  • To expand the current specimen bank comprised of liver tissue, serum, plasma, and DNA obtained from patients undergoing a 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

Keywords

Liver Diseases NAFLD NASH non-alcoholic steatohepatitis fatty liver disease Fatty Liver Non-alcoholic Fatty Liver Disease

Eligibility

You can join if…

Open to people ages 2 years and up

  • 2 years of age or older as of the initial screening interview and provision of consent
  • Willingness to participate in the study for 1 or more years
  • Histologic evidence of NAFLD or NASH based upon a standard of care liver biopsy
  • Collection of serum and plasma up to 90 days before or 4- 90 days after standard of care liver biopsy
  • Absence of regular or excessive use of alcohol within 2 years prior to initial screening

You CAN'T join if...

  • 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 (patients 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 of study
  • Inability to complete the appropriate informed consent process

Locations

  • University of California, San Diego- Adults
    La Jolla California 92103 United States
  • University of California, San Diego Pediatrics
    San Diego California 92103 United States

Lead Scientists at UCSD

  • Rohit Loomba, MD
    Professor, Medicine. Authored (or co-authored) 170 research publications.
  • Jeffrey Schwimmer, MD
    Professor Of Clinical, Pediatrics. Authored (or co-authored) 125 research publications.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Links
Nonalcoholic Steatohepatitis Clinical Research Consortium The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ID
NCT04454463
Study Type
Observational
Last Updated