Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04540731
Status:
NOT_YET_RECRUITING
Last Update Posted:
2020-09-07
First Post:
2020-08-29
Brief Title:
Multicenter Registry of Nonalcoholic Fatty Liver Disease
Sponsor:
Hospital Italiano de Buenos Aires
Organization:
Hospital Italiano de Buenos Aires
Study Overview
Official Title:
Multicenter Registry of Nonalcoholic Fatty Liver Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Non-alcoholic fatty liver disease NAFLD is the most prevalent liver disease worldwide affecting as much as 25 of the worlds 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
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 worlds 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None