NCT02298439

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Oct 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Oct 2013Jun 2026

Study Start

First participant enrolled

October 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

November 2, 2022

Status Verified

November 1, 2022

Enrollment Period

12.7 years

First QC Date

October 24, 2014

Last Update Submit

November 1, 2022

Conditions

Keywords

NAFLD

Outcome Measures

Primary Outcomes (1)

  • Disease categorization

    Specific diagnosis of NAFLD: simple steatosis (SS), steatohepatitis (NASH), cirrhosis

    Baseline

Secondary Outcomes (3)

  • Disease categorization

    at each clinic visit, up to 5 years

  • Liver biopsy results

    at each clinic visit, up to 5 years

  • Survival

    at each clinic visit, up to 5 years

Other Outcomes (10)

  • Patient demography

    at each clinic visit, up to 5 years

  • Anthropometry

    at each clinic visit, up to 5 years

  • Macro- and micronutrient intake

    at each clinic visit, up to 5 years

  • +7 more other outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Non-Alcoholic Fatty Liver Disease (NAFLD )which includes simple steatosis (SS) and non-alcoholic steatohepatitis (NASH) that being treated

You may qualify if:

  • \- Patients being treated for NAFLD at the Toronto General Hospital NAFLD clinic

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 1Z5, Canada

RECRUITING

Related Publications (5)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Johane Allard, MD, FRCPC

    UHN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anastasia Teterina, PhD

CONTACT

Akilen Rajadurai, PhD, BSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FRCPC

Study Record Dates

First Submitted

October 24, 2014

First Posted

November 24, 2014

Study Start

October 1, 2013

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

November 2, 2022

Record last verified: 2022-11

Locations