Non-Alcoholic Fatty Liver DiseaseNCT02298439
Fatty Liver Patient Registry
An observational study of Non-Alcoholic Fatty Liver Disease, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2013to Jun 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Non-Alcoholic Fatty Liver Disease (NAFLD )which includes simple steatosis (SS) and non-alcoholic steatohepatitis (NASH) that being treated
Who may be able to join
- Patients being treated for NAFLD at the Toronto General Hospital NAFLD clinic
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 1Z5
Johane P Allard, MD, FRCPC, 416-340-5159, johane.allard@uhn.on.ca
Anastasia Teterina, PhD, 416-340-4104, anastasia.teterina@uhnresearch.ca
About this study
Official title: Non-Alcoholic Fatty Liver Disease Patient Registry
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.
Read the 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- NAFLD
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease categorization
Specific diagnosis of NAFLD: simple steatosis (SS), steatohepatitis (NASH), cirrhosis
Measured: Baseline
Secondary outcomes (3)
Disease categorization
Specific diagnosis of NAFLD: simple steatosis (SS), steatohepatitis (NASH), cirrhosis
Measured: at each clinic visit, up to 5 years
Liver biopsy results
NAFLD fibrosis score, and elastography results
Measured: at each clinic visit, up to 5 years
Survival
Alive, death: causes, NAFLD-related or not
Measured: at each clinic visit, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startOct 2013
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johane Allard, University Health Network, Toronto
- Investigators
- Johane Allard, MD, FRCPC, Principal investigator, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298439
- Sponsor's protocol ID
- 13-6128-AE
- Status last verified
- Nov 2022
- First submitted
- 24 Oct 2014
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24587650Monteiro 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.
PubMed 24496399Allard 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.
PubMed 18086506Raman 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.
PubMed 16691301Allard 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.
PubMed 12406445
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Alcoholic Fatty Liver Disease Patient Registry
- ClinicalTrials.gov ID
- NCT02298439
- Acronym / sponsor ID
- 13-6128-AE
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- NAFLD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Non-Alcoholic Fatty Liver Disease (NAFLD )which includes simple steatosis (SS) and non-alcoholic steatohepatitis (NASH) that being treated
Key inclusion criteria (1 listed)
- Patients being treated for NAFLD at the Toronto General Hospital NAFLD clinic
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease categorization
Time frame: Baseline
Specific diagnosis of NAFLD: simple steatosis (SS), steatohepatitis (NASH), cirrhosis
3 secondary outcomes
Disease categorization
Time frame: at each clinic visit, up to 5 years
Liver biopsy results
Time frame: at each clinic visit, up to 5 years
Survival
Time frame: at each clinic visit, up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Results publication: PubMed 24587650Schwenger 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.
- Results publication: PubMed 24496399Monteiro 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.
- Results publication: PubMed 18086506Allard 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.
- Results publication: PubMed 16691301Raman 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.
- Results publication: PubMed 12406445Allard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johane Allard, MD, FRCPC principal investigator
UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anastasia Teterina, PhD (416-340-4104, anastasia.teterina@uhnresearch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease categorization (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02298439, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.