Reference range study for FGF-21 and hepcidin

  • Research type

    Research Study

  • Full title

    To establish reference ranges for fibroblast growth factor 21 (FGF-21) and hepcidin in the paediatric population

  • IRAS ID

    187046

  • Contact name

    GAYANI WEERASINGHE

  • Contact email

    gayani.weerasinghe@ouh.nhs.uk

  • Duration of Study in the UK

    1 years, 0 months, 1 days

  • Research summary

    Mitochondrial diseases constitute a group of metabolic diseases that affect people at all ages. Childhood mitochondrial disease is typically more severe than adult onset disease. The diagnosis is often challenging and it
    requires amalgamation of clinical, biochemical, enzymatic, histopathological and molecular data. Fibroblast growth factor 21 (FGF21)is tested in blood as a useful, sensitive marker of mitochondrial disorders involving muscles. Therefore, researchers have proved that FGF21 is a sensitive tool for screening patients suspected of having a mitochondrial disease and later to investigate further with more sophisticated tests according to the FGF21 result. This invariably leads to early diagnosis and ultimate reduction of cost for health care services. However,
    a normal range (reference interval) for this test has not been established to report patients' results. Our aim of this study is to establish a normal range for FGF21 for the paediatric population, and to include this test in the biochemistry test repertoire to help the clinicians in diagnosing patients with mitochondrial disorders. To establish a normal range in a healthy population at least 40 samples are adequate. However, with the feasibility and availability in finding participants we decided to recruit patients attending the paediatric endocrine clinic at the John Radcliffe Hospital. The participants with normal thyroid function tests at the time of blood collection will be recruited in the study. An extra blood sample (0.5ml) will be collected from the participants for FGF21 test who are already waiting for testing of their thyroid functions.

  • REC name

    East Midlands - Nottingham 2 Research Ethics Committee

  • REC reference

    15/EM/0519

  • Date of REC Opinion

    5 Jan 2016

  • REC opinion

    Further Information Favourable Opinion