Fatty Liver Patient Registry

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

Non-Alcoholic Fatty Liver Disease Patient Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02298439
• Other study ID #: 13-6128-AE
• Status: Recruiting
• Start date: October 2013
• Est. completion date: June 2026

Study information

• Verified date: November 2022
• Source: University Health Network, Toronto
• Contact: Anastasia Teterina, PhD
• Phone: 416-340-4104
• Email: anastasia.teterina[@]uhnresearch.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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-se — View Citation

Allard JP. Other disease associations with non-alcoholic fatty liver disease (NAFLD). Best Pract Res Clin Gastroenterol. 2002 Oct;16(5):783-95. Review. — View Citation

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 — View Citation

Raman M, Allard J. Non alcoholic fatty liver disease: a clinical approach and review. Can J Gastroenterol. 2006 May;20(5):345-9. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient demography	Age, sex, ethnicity, medical history from medical chart	at each clinic visit, up to 5 years
Other	Anthropometry	Body mass index, waist circumference	at each clinic visit, up to 5 years
Other	Macro- and micronutrient intake	Food records and food frequency questionnaires	at each clinic visit, up to 5 years
Other	Physical activity	Paffenbarger Physical Activity Questionnaire	at each clinic visit, up to 5 years
Other	Presence of metabolic syndrome		at each clinic visit, up to 5 years
Other	Medications	From clinical chart	at each clinic visit, up to 5 years
Other	Complete Blood Cell Count	Routine laboratory test	at each clinic visit, up to 5 years
Other	Biochemistry	Liver enzymes, total protein, albumin, glucose, insulin, and blood lipid	at each clinic visit, up to 5 years
Other	NAFLD specific diagnostic blood work	Ceruloplasmin, anti-smooth muscle antibodies	at each clinic visit, up to 5 years
Other	Cytokeratin 18	CK-18 fragments	at each clinic visit, up to 5 years
Primary	Disease categorization	Specific diagnosis of NAFLD: simple steatosis (SS), steatohepatitis (NASH), cirrhosis	Baseline
Secondary	Disease categorization	Specific diagnosis of NAFLD: simple steatosis (SS), steatohepatitis (NASH), cirrhosis	at each clinic visit, up to 5 years
Secondary	Liver biopsy results	NAFLD fibrosis score, and elastography results	at each clinic visit, up to 5 years
Secondary	Survival	Alive, death: causes, NAFLD-related or not	at each clinic visit, up to 5 years