Multicenter Registry of Nonalcoholic Fatty Liver Disease

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

Multicenter Registry of Nonalcoholic Fatty Liver Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04540731
• Other study ID #: 5530
• Status: Not yet recruiting
• Start date: October 2020
• Est. completion date: October 2025

Study information

• Verified date: September 2020
• Source: Hospital Italiano de Buenos Aires
• Contact: Sebastián Marciano
• Phone: 541150066086
• Email: sebastian.marciano[@]hospitalitaliano.org.ar
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Other:
• This is an observational study without intervention
This is an observational study without intervention

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

References & Publications (4)

Lindenmeyer CC, McCullough AJ. The Natural History of Nonalcoholic Fatty Liver Disease-An Evolving View. Clin Liver Dis. 2018 Feb;22(1):11-21. doi: 10.1016/j.cld.2017.08.003. Review. — View Citation

Patel PJ, Banh X, Horsfall LU, Hayward KL, Hossain F, Johnson T, Stuart KA, Brown NN, Saad N, Clouston A, Irvine KM, Russell AW, Valery PC, Williams S, Powell EE. Underappreciation of non-alcoholic fatty liver disease by primary care clinicians: limited a — View Citation

Rinella ME, Lominadze Z, Loomba R, Charlton M, Neuschwander-Tetri BA, Caldwell SH, Kowdley K, Harrison SA. Practice patterns in NAFLD and NASH: real life differs from published guidelines. Therap Adv Gastroenterol. 2016 Jan;9(1):4-12. doi: 10.1177/1756283 — View Citation

Younossi ZM. Non-alcoholic fatty liver disease - A global public health perspective. J Hepatol. 2019 Mar;70(3):531-544. doi: 10.1016/j.jhep.2018.10.033. Epub 2018 Nov 9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-invasive fibrosis scores progression over time	Change in non-invasive fibrosis scores over time	5 years
Primary	Incidence of cirrhosis	Incidence of cirrhosis	5 years
Primary	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	Fibrosis progression over time	Change in fibrosis score according to liver biopsies over time	5 years