Fatty Acids, Genes and Microbiota in Fatty Liver

NCT02148471 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 205

Last updated 2016-05-12

No results posted yet for this study

Summary

The first aim of this study is to assess oxidative stress and nutritional status in patients with elevated liver enzymes who were found to have either simple steatosis (SS) or nonalcoholic steatohepatitis (NASH) or normal histological findings on liver biopsy by measuring liver lipid peroxides and tumor necrosis factor (TNF)-α, liver pathology and immunohistochemistry, liver function tests, liver and red blood cell membrane fatty composition, insulin resistance (IR) parameters, plasma lipid peroxides, plasma antioxidant vitamins and antioxidant power, lipid profile, subject demographics, medical history and medication use. The second aim is to detect differences in hepatic gene expression (messenger RNA, mRNA) and epigenetic regulation (micro RNA, miRNA) between patients with SS or NASH and healthy controls, in addition to determine in patients with non-alcoholic fatty liver disease (NAFLD = SS+NASH combined) whether there is an association between hepatic n-3 PUFA content and gene expression. The third aim is to determine the intestinal microbiome (microbial composition and metagenome) in patients with SS or NASH and healthy controls.

Conditions

Sponsors & Collaborators

  • Canadian Liver Foundation

    collaborator UNKNOWN
  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • American College of Gastroenterology

    collaborator OTHER
  • Johane Allard

    lead OTHER

Principal Investigators

  • Johane Allard, MD,FRCPC · University Health Network, Toronto

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02148471 on ClinicalTrials.gov