- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02298439
Fatty Liver Patient Registry
Non-Alcoholic Fatty Liver Disease Patient Registry
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienkontakt
- Name: Anastasia Teterina, PhD
- Telefonnummer: 416-340-4104
- E-Mail: anastasia.teterina@uhnresearch.ca
Studieren Sie die Kontaktsicherung
- Name: Akilen Rajadurai, PhD, BSc
- Telefonnummer: 416-340-4104
- E-Mail: arajadur@uhnresearch.ca
Studienorte
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Ontario
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Toronto, Ontario, Kanada, M5G 1Z5
- Rekrutierung
- Toronto General Hospital
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Kontakt:
- Anastasia Teterina, PhD
- Telefonnummer: 416-340-4104
- E-Mail: anastasia.teterina@uhnresearch.ca
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Kontakt:
- Johane P Allard, MD, FRCPC
- Telefonnummer: 416-340-5159
- E-Mail: johane.allard@uhn.on.ca
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Hauptermittler:
- Johane Allard, MD,FRCPC
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Patients being treated for NAFLD at the Toronto General Hospital NAFLD clinic
Exclusion Criteria:
- None
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Kohorte
- Zeitperspektiven: Interessent
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Disease categorization
Zeitfenster: Baseline
|
Specific diagnosis of NAFLD: simple steatosis (SS), steatohepatitis (NASH), cirrhosis
|
Baseline
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Disease categorization
Zeitfenster: 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
Zeitfenster: at each clinic visit, up to 5 years
|
NAFLD fibrosis score, and elastography results
|
at each clinic visit, up to 5 years
|
Survival
Zeitfenster: at each clinic visit, up to 5 years
|
Alive, death: causes, NAFLD-related or not
|
at each clinic visit, up to 5 years
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Patient demography
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: at each clinic visit, up to 5 years
|
Food records and food frequency questionnaires
|
at each clinic visit, up to 5 years
|
Physical activity
Zeitfenster: at each clinic visit, up to 5 years
|
Paffenbarger Physical Activity Questionnaire
|
at each clinic visit, up to 5 years
|
Presence of metabolic syndrome
Zeitfenster: at each clinic visit, up to 5 years
|
at each clinic visit, up to 5 years
|
|
Medications
Zeitfenster: at each clinic visit, up to 5 years
|
From clinical chart
|
at each clinic visit, up to 5 years
|
Complete Blood Cell Count
Zeitfenster: at each clinic visit, up to 5 years
|
Routine laboratory test
|
at each clinic visit, up to 5 years
|
Biochemistry
Zeitfenster: 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
Zeitfenster: at each clinic visit, up to 5 years
|
Ceruloplasmin, anti-smooth muscle antibodies
|
at each clinic visit, up to 5 years
|
Cytokeratin 18
Zeitfenster: at each clinic visit, up to 5 years
|
CK-18 fragments
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at each clinic visit, up to 5 years
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Johane Allard, MD, FRCPC, UHN
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 13-6128-AE
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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