Fatty Liver Patient Registry

Non-Alcoholic Fatty Liver Disease Patient Registry

The purpose of the Non-Alcoholic Fatty Liver Disease (NAFLD) registry is to collect demographic and clinical data on patients being treated for NAFLD and to determine the factors affecting the progression of the disease as well as the success of different treatment strategies.

Study Overview

• Status: Recruiting
• Conditions: Non-Alcoholic Fatty Liver Disease

Detailed Description

The NAFLD registry is a local database provided by the principal investigator, Dr. J. Allard, which will be stored on the Research Intranet at the University Health Network, Toronto. The database will be password protected. Only clinic personnel and members of Dr. Allard's research team involved in the study will have access to the database. A code and date of birth will be used to identify each patient. All patients entering the NAFLD clinic at Toronto General Hospital will be consented for the registry. Only data from their regular clinic visits will be used for entry into the registry. Data entered into the registry will include: 1) Patient demography: age, sex, ethnicity, medical history; 2) Anthropometry: weight, height, BMI, waist circumference; 3) Nutritional assessment: Food records and food frequency questionnaires are kept by the subjects and data will be analyzed to assess the intake of macro- and micronutrients. Amount of alcohol and number of cigarette smoked will also be recorded; 4) Physical Activity will be assessed using the Paffenbarger Physical Activity Questionnaire; 5) Medications: insulin, non-steroidal anti-inflammatory drugs, corticosteroids, statins, medications used to treat diabetes/obesity (e.g. metformin, thiazolidinediones, orlistat…), medication to treat liver disease (eg. urso, carnitine, choline…), antioxidant vitamin or fish oil supplementation; 6) Blood work, currently including: complete blood count, biochemistry including liver enzymes, total protein, albumin, glucose, insulin, and blood lipid profile; other diagnostic blood work done to exclude other causes of liver disease, e.g. ceruloplasmin, anti-smooth muscle antibodies,… One plasma sample will be stored for assessment of cytokeratin 18 (CK-18) fragments as a novel marker for NASH in patients with NAFLD; 7) Presence of metabolic syndrome; 8) Disease categorization: SS, NASH, cirrhosis; 9) Survival: alive, death: causes, NAFLD-related or not NAFLD-related; 10) Liver biopsy results, NAFLD fibrosis score, and elastography results.

Data will be entered after every clinic visit. Case report forms will be used to collect the data from the patient charts and facilitate data input into the registry database All patients will be followed prospectively until withdrawal from the clinic or death. Descriptive statistics will be performed. For the entire NAFLD population, probability of survival, cirrhosis, as well as liver and non-liver related morbidity will be calculated using the Kaplan Meier method.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Anastasia Teterina, PhD; Phone Number: 416-340-4104; Email: anastasia.teterina@uhnresearch.ca
• Study Contact Backup: Name: Akilen Rajadurai, PhD, BSc; Phone Number: 416-340-4104; Email: arajadur@uhnresearch.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1Z5
      • Recruiting
      • Toronto General Hospital
      • Contact: Anastasia Teterina, PhD; Phone Number: 416-340-4104; Email: anastasia.teterina@uhnresearch.ca
      • Contact: Johane P Allard, MD, FRCPC; Phone Number: 416-340-5159; Email: johane.allard@uhn.on.ca
      • Principal Investigator: Johane Allard, MD,FRCPC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Non-Alcoholic Fatty Liver Disease (NAFLD )which includes simple steatosis (SS) and non-alcoholic steatohepatitis (NASH) that being treated

Description

Inclusion Criteria:

- Patients being treated for NAFLD at the Toronto General Hospital NAFLD clinic

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease categorization	Specific diagnosis of NAFLD: simple steatosis (SS), steatohepatitis (NASH), cirrhosis	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease categorization	Specific diagnosis of NAFLD: simple steatosis (SS), steatohepatitis (NASH), cirrhosis	at each clinic visit, up to 5 years
Liver biopsy results	NAFLD fibrosis score, and elastography results	at each clinic visit, up to 5 years
Survival	Alive, death: causes, NAFLD-related or not	at each clinic visit, up to 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient demography	Age, sex, ethnicity, medical history from medical chart	at each clinic visit, up to 5 years
Anthropometry	Body mass index, waist circumference	at each clinic visit, up to 5 years
Macro- and micronutrient intake	Food records and food frequency questionnaires	at each clinic visit, up to 5 years
Physical activity	Paffenbarger Physical Activity Questionnaire	at each clinic visit, up to 5 years
Presence of metabolic syndrome		at each clinic visit, up to 5 years
Medications	From clinical chart	at each clinic visit, up to 5 years
Complete Blood Cell Count	Routine laboratory test	at each clinic visit, up to 5 years
Biochemistry	Liver enzymes, total protein, albumin, glucose, insulin, and blood lipid	at each clinic visit, up to 5 years
NAFLD specific diagnostic blood work	Ceruloplasmin, anti-smooth muscle antibodies	at each clinic visit, up to 5 years
Cytokeratin 18	CK-18 fragments	at each clinic visit, up to 5 years

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Johane Allard, MD, FRCPC, UHN

Publications and helpful links

General Publications

• Allard JP, Aghdassi E, Mohammed S, Raman M, Avand G, Arendt BM, Jalali P, Kandasamy T, Prayitno N, Sherman M, Guindi M, Ma DW, Heathcote JE. Nutritional assessment and hepatic fatty acid composition in non-alcoholic fatty liver disease (NAFLD): a cross-sectional study. J Hepatol. 2008 Feb;48(2):300-7. doi: 10.1016/j.jhep.2007.09.009. Epub 2007 Nov 20.
• Schwenger KJ, Allard JP. Clinical approaches to non-alcoholic fatty liver disease. World J Gastroenterol. 2014 Feb 21;20(7):1712-23. doi: 10.3748/wjg.v20.i7.1712.
• Monteiro J, Leslie M, Moghadasian MH, Arendt BM, Allard JP, Ma DW. The role of n - 6 and n - 3 polyunsaturated fatty acids in the manifestation of the metabolic syndrome in cardiovascular disease and non-alcoholic fatty liver disease. Food Funct. 2014 Mar;5(3):426-35. doi: 10.1039/c3fo60551e.
• Raman M, Allard J. Non alcoholic fatty liver disease: a clinical approach and review. Can J Gastroenterol. 2006 May;20(5):345-9. doi: 10.1155/2006/918262.
• Allard JP. Other disease associations with non-alcoholic fatty liver disease (NAFLD). Best Pract Res Clin Gastroenterol. 2002 Oct;16(5):783-95. doi: 10.1053/bega.2002.0330.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Anticipated): June 1, 2026
• Study Completion (Anticipated): June 1, 2026

Study Registration Dates

• First Submitted: October 24, 2014
• First Submitted That Met QC Criteria: November 19, 2014
• First Posted (Estimate): November 24, 2014

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: NAFLD
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 13-6128-AE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No