Nonalcoholic Fatty Liver Disease (NAFLD) Database 3

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a multicenter, prospective follow-up study of patients with known nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH). The primary objective of the study is to investigate the etiology, pathogenesis, natural history, diagnosis, treatment, and prevention of NAFLD and NASH.

Official Title
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Nonalcoholic Fatty Liver Disease (NAFLD) Database 3

Conditions
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Liver Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult patients with NAFLD<br>1500 patients 18 years and older at the time of enrollment. | |
| Pediatric patients with NAFLD<br>750 patients 2 years or older and up to 17 years old at the time of enrollment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in alanine aminotransferase (ALT) levels from baseline to one year. | ALT measure in IU/L (higher ALT indicates worse outcomes) | Baseline and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAFLD, NASH, non-alcoholic steatohepatitis, fatty liver disease