Multicenter Registry of Nonalcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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Non-alcoholic fatty liver disease (NAFLD) is the most prevalent liver disease worldwide affecting as much as 25% of the world's population. The spectrum of NAFLD ranges from non-alcoholic fatty liver to non-alcoholic steatohepatitis (NASH), the latter being associated with a progressive course towards fibrosis and a higher risk of developing cirrhosis and hepatocellular carcinoma. Patients with type 2 diabetes are particularly at higher risk of developing fibrosis and advanced liver disease. Since NASH and its consequences will only occur in a minority of patients, it is of paramount importance to identify this population to offer them proper care. It is well known that there is a lack of awareness about the potential consequences of NAFLD, not only in the general population but also in the medical community. Patients with NAFLD are frequently lost during follow up and, additionally, approach to these patients is sub-optimal and heterogeneous among physicians. An attractive approach to applying best medical practices to patients with NAFLD is to generate a multicentre registry. Clinical registries comprise a set of systematic collected and stored data focused on a specific condition. The information stored in a registry provides relevant information about a disease and, through a process of error detection, ensures data quality and reliability. A NAFLD registry is an essential tool for providing relevant information such as epidemiological aspects of the disease, outcomes, and treatment effectiveness. As far as we concern, this would be the first registry of NAFLD in our region, a region where the disease behaves in a more aggressive way in comparison with other regions and hemispheres. By generating this registry, we are confident that we will obtain objective information on the characteristic of patients with NAFLD in our region, not only of the disease characteristics but also of social determinants that might influence disease outcomes. By being a prospective study, it allows an adequate patient follow up.

Detailed Description
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Non-alcoholic fatty liver disease (NAFLD) is the most prevalent liver disease worldwide affecting as much as 25% of the world's population. The spectrum of NAFLD ranges from non-alcoholic fatty liver to non-alcoholic steatohepatitis (NASH), the latter being associated with a progressive course towards fibrosis and a higher risk of developing cirrhosis and hepatocellular carcinoma. Patients with type 2 diabetes are particularly at higher risk of developing fibrosis and advanced liver disease. Since NASH and its consequences will only occur in a minority of patients, it is of paramount importance to identify this population to offer them proper care. It is well known that there is a lack of awareness about the potential consequences of NAFLD, not only in the general population but also in the medical community. Patients with NAFLD are frequently lost during follow up and, additionally, approach to these patients is sub-optimal and heterogeneous among physicians. An attractive approach to applying best medical practices to patients with NAFLD is to generate a multicentre registry. Clinical registries comprise a set of systematic collected and stored data focused on a specific condition. The information stored in a registry provides relevant information about a disease and, through a process of error detection, ensures data quality and reliability. A NAFLD registry is an essential tool for providing relevant information such as epidemiological aspects of the disease, outcomes, and treatment effectiveness. As far as we concern, this would be the first registry of NAFLD in our region, a region where the disease behaves in a more aggressive way in comparison with other regions and hemispheres. By generating this registry, we are confident that we will obtain objective information on the characteristic of patients with NAFLD in our region, not only of the disease characteristics but also of social determinants that might influence disease outcomes. By being a prospective study, it allows an adequate patient follow up. With this registry we primarily aim to: Describe the characteristics of patients with non-alcoholic fatty liver disease Evaluate the disease progression over time (in the sub-group of patients with type 2 diabetes or insulin resistance) Identify barriers to achieve best medical practices in non-alcoholic fatty liver disease, such as barriers to adhere to treatment recommendations ,and to access to complementary studies such as elastography or liver biopsy. Evaluate patient reported outcomes

Official Title
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Multicenter Registry of Nonalcoholic Fatty Liver Disease

Conditions
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Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
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* Other: This is an observational study without intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (greater than 16-year-old) NAFLD (defined as proposed by the European Association for the Study of the Liver and the Argentinean Association for the Study of the Liver: evidence of hepatic steatosis, either by imaging or histology, and lack of secondary causes of liver fat accumulation such as significant alcohol consumption ( >30 g/day for men or > 20 g/day for women), long term use of medications known to cause steatosis, or monogenic hereditary disorders. Exclusion Criteria: Unwillingness to participate in the registry

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 100 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 |
| --- | --- |
| NAFLD and diabetes/NASH and fibrosis<br>Patients with NAFLD and type 2 diabetes (or insulin-resistance) or with any stage of fibrosis in the inclusion visit will be followed over time in a prospective cohort study with scheduled visits. Patients without diabetes/insulin-resistance or any stage of fibrosis will participle in a single visit (inclusion) and will be part of a cross-sectional study. | Other: This is an observational study without intervention<br>* This is an observational study without intervention<br>|
| NAFLD without diabetes/NASH without fibrosis<br>Patients without diabetes (or insulin-resistance) or any stage of fibrosis will participle in a single visit (inclusion) and will be part of a cross-sectional study | Other: This is an observational study without intervention<br>* This is an observational study without intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-invasive fibrosis scores progression over time | Change in non-invasive fibrosis scores over time | 5 years | 
| Incidence of cirrhosis | Incidence of cirrhosis | 5 years | 
| Incidence of liver-related complications | Incidence of liver-related complications, defined as any of the following: ascites, encephalopathy, gastroesophageal varices, bleeding gastroesophageal varices or hepatocellular carcinoma, whichever occurs first | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibrosis progression over time | Change in fibrosis score according to liver biopsies over time | 5 years |