Multicenter Registry of Nonalcoholic Fatty Liver Disease

NCT04540731 | Unknown DMC

• 1 other identifier: 5530
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Fibrosis progression over time

  5 years

Study Arms (2)

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

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

Interventions

This is an observational study without intervention OTHER

This is an observational study without intervention

NAFLD and diabetes/NASH and fibrosis; NAFLD without diabetes/NASH without fibrosis

Eligibility Criteria

• Age: 7 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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."

You may not qualify if:

• Unwillingness to participate in the registry

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, 1643, Argentina

Location

Related Publications (4)

• 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.

  PMID: 30414863 RESULT

• 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.

  PMID: 29128051 RESULT

• 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.

  PMID: 29083080 RESULT

• 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.

  PMID: 26770262 RESULT

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Methods

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Sebastián Marciano

CONTACT

541150066086; sebastian.marciano@hospitalitaliano.org.ar

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Hepatology

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 7, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 7, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)