Clinical trial NCT02298439: Fatty Liver Patient Registry
Official title: Non-Alcoholic Fatty Liver Disease Patient Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: NAFLD
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Disease categorization
timeFrame: Baseline
Secondary outcomes:
measure: Disease categorization
timeFrame: at each clinic visit, up to 5 years
measure: Liver biopsy results
timeFrame: at each clinic visit, up to 5 years
measure: Survival
timeFrame: at each clinic visit, up to 5 years
Other outcomes:
measure: Patient demography
timeFrame: at each clinic visit, up to 5 years
measure: Anthropometry
timeFrame: at each clinic visit, up to 5 years
measure: Macro- and micronutrient intake
timeFrame: at each clinic visit, up to 5 years
measure: Physical activity
timeFrame: at each clinic visit, up to 5 years
measure: Presence of metabolic syndrome
timeFrame: at each clinic visit, up to 5 years
measure: Medications
timeFrame: at each clinic visit, up to 5 years
measure: Complete Blood Cell Count
timeFrame: at each clinic visit, up to 5 years
measure: Biochemistry
timeFrame: at each clinic visit, up to 5 years
measure: NAFLD specific diagnostic blood work
timeFrame: at each clinic visit, up to 5 years
measure: Cytokeratin 18
timeFrame: at each clinic visit, up to 5 years
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: UHN
name: Johane Allard, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
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.
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;5(3):426-35. doi: 10.1039/c3fo60551e.
citation: 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.
citation: 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.
citation: 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.