Recruiting

Observational Study

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT03128918

Conditions

Non-alcoholic Fatty Liver Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of this study is is to use non-invasive diagnostic tests, Fibroscan and a simple blood test, to diagnose NASH in patients who undergo liver transplantation. Liver transplantation is a life-saving procedure for people with cirrhosis. Fatty liver is a common reason for liver transplantation due to obesity and diabetes. Fatty liver can happen again to the new transplanted liver and it is often due to metabolic risk factors (including diabetes, rapid weight gain, and immunosuppressive therapy, which are used to avoid rejection of the new liver). Some patients with fatty liver after liver transplant have non-alcoholic steatohepatitis (NASH) injury to liver the tissue (inflammation) and damage which is caused by a build-up of fat in the liver. This is a serious problem and can lead to cirrhosis and loss of the transplanted liver. There has been no detailed study into the recurrence of NASH. One reason for this is one of the only ways to detect fatty liver and NASH is to have a liver biopsy, which can be painful and have complications. Recently, a new technology (Fibroscan) and a simple blood test (cytokeratin 18) have been developed which can tell doctors how much a liver is damaged and how much fat it contains without pain or complications. This is a year long study involving one screening visit and 3 study visits, 3 months apart.

Conditions

Non-alcoholic Fatty Liver Disease

Study ID

NCT03128918

Start date

Jul, 2015

Status verified date

Apr, 2017

Completion date

Sep, 2017

Anticipated

Primary completion date

Sep, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Liver transplant recipient of any etiology;
  • >18 years old;
  • Able to provide informed consent.

Exclusion Criteria:

  • Liver transplant due to alcoholic liver disease as primary etiology;
  • Liver transplant due to chronic hepatitis C, genotype 3.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Incidence of NASH in liver transplant recipients [ Time Frame: 18 months ]
  • Evaluation of liver steatosis in liver transplant recipients [ Time Frame: 18 months ]
  • Incidence of fibrosis [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Locations

Mcgill University Health Center

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Apr 25, 2017

Last verified

Apr, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2017-04-25.