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.