An observational study in Non-Alcoholic Fatty Liver Disease, sponsored by Hospital Italiano de Buenos Aires. Not yet recruiting at 1 site in Argentina. Open to participants aged 7 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-09-07.
Sponsored by Hospital Italiano de Buenos Aires · Observational
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.
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:
2,080 studies on the registry are indexed under Liver Diseases; 389 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 167 across 681 observational studies indexed under Liver Diseases.
Browse Liver Diseases studies →Hospital Italiano de Buenos Aires is the lead sponsor of 128 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients with NAFLD.
In order to properly classify patients with diabetes or insulin resistance, the following criteria will be used:
-Diabetes: Patients receiving oral anti-diabetic drugs and/or insulin, or who presented a glycated hemoglobin > 6.5 gr/dL or at least 2 fasting glucose levels > 126 mg/dL) Insulin resistance: according to predefined criteria of waist circumference for males and females.
Exclusion Criteria:
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
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
This is an observational study without intervention
Non-invasive fibrosis scores progression over time
Change in non-invasive fibrosis scores over time
Time frame: 5 years
Incidence of cirrhosis
Incidence of cirrhosis
Time frame: 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
Time frame: 5 years
Fibrosis progression over time
Change in fibrosis score according to liver biopsies over time
Time frame: 5 years
Plan to share: No
This study is not yet recruiting, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Hospital Italiano de Buenos Aires