- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02298439
Fatty Liver Patient Registry
Non-Alcoholic Fatty Liver Disease Patient Registry
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Anastasia Teterina, PhD
- Número de teléfono: 416-340-4104
- Correo electrónico: anastasia.teterina@uhnresearch.ca
Copia de seguridad de contactos de estudio
- Nombre: Akilen Rajadurai, PhD, BSc
- Número de teléfono: 416-340-4104
- Correo electrónico: arajadur@uhnresearch.ca
Ubicaciones de estudio
-
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Ontario
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Toronto, Ontario, Canadá, M5G 1Z5
- Reclutamiento
- Toronto General Hospital
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Contacto:
- Anastasia Teterina, PhD
- Número de teléfono: 416-340-4104
- Correo electrónico: anastasia.teterina@uhnresearch.ca
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Contacto:
- Johane P Allard, MD, FRCPC
- Número de teléfono: 416-340-5159
- Correo electrónico: johane.allard@uhn.on.ca
-
Investigador principal:
- Johane Allard, MD,FRCPC
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients being treated for NAFLD at the Toronto General Hospital NAFLD clinic
Exclusion Criteria:
- None
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Disease categorization
Periodo de tiempo: Baseline
|
Specific diagnosis of NAFLD: simple steatosis (SS), steatohepatitis (NASH), cirrhosis
|
Baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Disease categorization
Periodo de tiempo: at each clinic visit, up to 5 years
|
Specific diagnosis of NAFLD: simple steatosis (SS), steatohepatitis (NASH), cirrhosis
|
at each clinic visit, up to 5 years
|
Liver biopsy results
Periodo de tiempo: at each clinic visit, up to 5 years
|
NAFLD fibrosis score, and elastography results
|
at each clinic visit, up to 5 years
|
Survival
Periodo de tiempo: at each clinic visit, up to 5 years
|
Alive, death: causes, NAFLD-related or not
|
at each clinic visit, up to 5 years
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Patient demography
Periodo de tiempo: at each clinic visit, up to 5 years
|
Age, sex, ethnicity, medical history from medical chart
|
at each clinic visit, up to 5 years
|
Anthropometry
Periodo de tiempo: at each clinic visit, up to 5 years
|
Body mass index, waist circumference
|
at each clinic visit, up to 5 years
|
Macro- and micronutrient intake
Periodo de tiempo: at each clinic visit, up to 5 years
|
Food records and food frequency questionnaires
|
at each clinic visit, up to 5 years
|
Physical activity
Periodo de tiempo: at each clinic visit, up to 5 years
|
Paffenbarger Physical Activity Questionnaire
|
at each clinic visit, up to 5 years
|
Presence of metabolic syndrome
Periodo de tiempo: at each clinic visit, up to 5 years
|
at each clinic visit, up to 5 years
|
|
Medications
Periodo de tiempo: at each clinic visit, up to 5 years
|
From clinical chart
|
at each clinic visit, up to 5 years
|
Complete Blood Cell Count
Periodo de tiempo: at each clinic visit, up to 5 years
|
Routine laboratory test
|
at each clinic visit, up to 5 years
|
Biochemistry
Periodo de tiempo: at each clinic visit, up to 5 years
|
Liver enzymes, total protein, albumin, glucose, insulin, and blood lipid
|
at each clinic visit, up to 5 years
|
NAFLD specific diagnostic blood work
Periodo de tiempo: at each clinic visit, up to 5 years
|
Ceruloplasmin, anti-smooth muscle antibodies
|
at each clinic visit, up to 5 years
|
Cytokeratin 18
Periodo de tiempo: at each clinic visit, up to 5 years
|
CK-18 fragments
|
at each clinic visit, up to 5 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Johane Allard, MD, FRCPC, UHN
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 13-6128-AE
Información sobre medicamentos y dispositivos, documentos del estudio
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