Liver function assessment by breath analysis

  • Research type

    Research Study

  • Full title

    Reproducibility of the hepatic metabolism of 13C-ketoisocaproate in healthy people.

  • IRAS ID

    184363

  • Contact name

    Chris Byrne

  • Contact email

    C.D.Byrne@soton.ac.uk

  • Duration of Study in the UK

    1 years, 0 months, 1 days

  • Research summary

    The ‘Reproducibility of the hepatic metabolism of 13C-ketoisocaproate in healthy people’ study aims to assess the reproducibility of a simple new test that assesses the function of liver tissue. To assess the reproducibility of this test we are recruiting healthy volunteers who will undergo the new test, plus a blood test and also a test of liver stiffness (Fibroscan) that enables the assessment of liver fat and liver fibrosis. Participants undergo the new test and the Fibroscan on two occasions separated by approximately 28 days. The new test involves asking healthy participants to come to the Clinical Research Facility (CRF) at Southampton General Hospital for approximately two hours. Participants will drink 200mls of water containing a stable non radio-active isotope 13C keto-isocaproate (13C-KICA) plus L-leucine, and will then exhale into breath tubes. The information obtained from this study will allow us to assess the reproducibility of the new test and will allow us compare the results of the new test with more established measurements of liver function that are currently used in the NHS. All participants taking part in the study will provide informed consent and participants will be advised of their test results in writing when these become available.

  • REC name

    South Central - Hampshire B Research Ethics Committee

  • REC reference

    15/SC/0619

  • Date of REC Opinion

    7 Dec 2015

  • REC opinion

    Further Information Favourable Opinion