A follow-up study to evaluate bone microarchitecture in T1D V 1.0

  • Research type

    Research Study

  • Full title

    A longitudinal study (follow-up study to IRAS number 222726, An evaluation of bone microarchitecture in Type 1 diabetes) of microRNA expression levels, bone mineral density, bone microarchitecture, bone turnover markers, advanced glycation end products and hormones regulating bone remodelling in people with type 1 diabetes with and without neuropathy in South Yorkshire, United Kingdom and the comparison with healthy controls.

  • IRAS ID

    303770

  • Contact name

    Ankita Duseja

  • Contact email

    a.duseja@sheffield.ac.uk

  • Sponsor organisation

    Sheffield Teaching Hospitals NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    R/160415-11-1, funds held by University of Sheffield

  • Duration of Study in the UK

    1 years, 4 months, 31 days

  • Research summary

    Patients with type 1 diabetes are more prone to fractures compared to those without the disease. Moreover, it seems to be more important in diabetic patients with nerve damage. A previous study done by our team reported bone to be more porous in patients with type 1 diabetes and nerve damage compared to those without nerve damage. The reasons for this are not completely understood, neither do we know how bone structure changes as the disease progresses. To investigate this, we will conduct a follow-up study (to a previous study regarding bone microarchitecture in type 1 diabetes) to evaluate how bone health and structure changes over time in people with and without the disease. To understand if the presence of nerve damage is important, we will also evaluate patients with and without nerve damage.
    In our blood, there are molecules that help in normal body functioning, including good bone health. The levels of these molecules are known to be different between healthy people and those with a disease condition. We are interested in identifying those molecules in the blood that will help us differentiate between people with and without type 1 diabetes, how these molecules change over time as duration of diabetes increases and if they may be associated with nerve damage.
    Participants who took part in the previously mentioned study run by STH will be invited to participate in this study. The average follow-up time will be 4 1/2 years. The aim of this study is to look for differences in bone structure over the average period of 4 1/2 years and measure different molecules present in blood that would help us differentiate between our participant groups of interest. This will be done with the help of blood tests and bone scans.

  • REC name

    London - Harrow Research Ethics Committee

  • REC reference

    21/PR/1712

  • Date of REC Opinion

    3 Feb 2022

  • REC opinion

    Further Information Favourable Opinion