Multicenter Registry of Nonalcoholic Fatty Liver Disease

Not yet recruiting

• Conditions: Non-Alcoholic Fatty Liver Disease

• Registration Number: NCT04540731
• Lead Sponsor: Hospital Italiano de Buenos Aires

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2020-08-29
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-01
• Last Update Submitted: 2020-09-01
• Study First Posted: 2020-09-07
• Last Update Posted: 2020-09-07
• Study Start: 2020-10
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Fibrosis progression over time	5 years	Change in fibrosis score according to liver biopsies over time

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires; 🇦🇷 Buenos Aires, Argentina