Multicenter Registry of Nonalcoholic Fatty Liver Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Other: This is an observational study without intervention

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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Sebastián Marciano; Phone Number: 541150066086; Email: sebastian.marciano@hospitalitaliano.org.ar

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1643
    • Hospital Italiano de Buenos Aires
    • Contact: Sebastián Marciano, MD, MsC; Phone Number: 1150066086; Email: sebastian.marciano@hospitalitaliano.org.ar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NAFLD and diabetes/NASH and fibrosis; 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; This is an observational study without intervention
NAFLD without diabetes/NASH without fibrosis; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Italiano de Buenos Aires

Publications and helpful links

General Publications

• 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.
• 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.
• 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 awareness of surrogate markers of fibrosis. Intern Med J. 2018 Feb;48(2):144-151. doi: 10.1111/imj.13667.
• 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: 10.1177/1756283X15611581.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): October 1, 2025
• Study Completion (Anticipated): October 1, 2025

Study Registration Dates

• First Submitted: August 29, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Actual): September 7, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 5530

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No