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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Disease categorization | Specific diagnosis of NAFLD: simple steatosis (SS), steatohepatitis (NASH), cirrhosis | Baseline |
| 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 |
| 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 |
Inclusion Criteria:
- Patients being treated for NAFLD at the Toronto General Hospital NAFLD clinic
Exclusion Criteria:
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Patients with Non-Alcoholic Fatty Liver Disease (NAFLD )which includes simple steatosis (SS) and non-alcoholic steatohepatitis (NASH) that being treated
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anastasia Teterina, PhD | Contact | 416-340-4104 | anastasia.teterina@uhnresearch.ca | |
| Akilen Rajadurai, PhD, BSc | Contact | 416-340-4104 | arajadur@uhnresearch.ca |
| Name | Affiliation | Role |
|---|---|---|
| Johane Allard, MD, FRCPC | UHN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto General Hospital | Recruiting | Toronto | Ontario | M5G 1Z5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24587650 | Result | 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. | |
| 24496399 | Result | 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. |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| at each clinic visit, up to 5 years |
| Survival | Alive, death: causes, NAFLD-related or not | at each clinic visit, up to 5 years |
| 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 |
| 18086506 | Result | 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. |
| 16691301 | Result | 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. |
| 12406445 | Result | 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. |