Fatty Liver Patient Registry
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- Disease categorization [Baseline]
Specific diagnosis of NAFLD: simple steatosis (SS), steatohepatitis (NASH), cirrhosis
Secondary Outcome Measures
- Disease categorization [at each clinic visit, up to 5 years]
Specific diagnosis of NAFLD: simple steatosis (SS), steatohepatitis (NASH), cirrhosis
- Liver biopsy results [at each clinic visit, up to 5 years]
NAFLD fibrosis score, and elastography results
- Survival [at each clinic visit, up to 5 years]
Alive, death: causes, NAFLD-related or not
Other Outcome Measures
- Patient demography [at each clinic visit, up to 5 years]
Age, sex, ethnicity, medical history from medical chart
- Anthropometry [at each clinic visit, up to 5 years]
Body mass index, waist circumference
- Macro- and micronutrient intake [at each clinic visit, up to 5 years]
Food records and food frequency questionnaires
- Physical activity [at each clinic visit, up to 5 years]
Paffenbarger Physical Activity Questionnaire
- Presence of metabolic syndrome [at each clinic visit, up to 5 years]
- Medications [at each clinic visit, up to 5 years]
From clinical chart
- Complete Blood Cell Count [at each clinic visit, up to 5 years]
Routine laboratory test
- Biochemistry [at each clinic visit, up to 5 years]
Liver enzymes, total protein, albumin, glucose, insulin, and blood lipid
- NAFLD specific diagnostic blood work [at each clinic visit, up to 5 years]
Ceruloplasmin, anti-smooth muscle antibodies
- Cytokeratin 18 [at each clinic visit, up to 5 years]
CK-18 fragments
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients being treated for NAFLD at the Toronto General Hospital NAFLD clinic
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Toronto General Hospital | Toronto | Ontario | Canada | M5G 1Z5 |
Sponsors and Collaborators
- University Health Network, Toronto
Investigators
- Principal Investigator: Johane Allard, MD, FRCPC, UHN
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 13-6128-AE