Steroids and their impact on your muscles and physical activity

• Research type

  Research Study

• Full title

  STAY ACTIV: Assessment of the muscular, vascular and endocrine effects of glucocorticoid therapy in inflammatory diseases.

• IRAS ID

  153876

• Contact name

  Sarah Mackie

• Contact email

  s.l.mackie@leeds.ac.uk

• Research summary

  What is the effect of glucocorticoid treatment on the muscular, vascular and endocrine systems in patients with inflammatory disease?
  The treatment for inflammatory diseases such as polymyalgia rheumatica (PMR) and giant cell arteritis (GCA) is steroid (glucocorticoid) tablets. However, patients are often required to take these tablets for 2 years or more, and regularly experience unwanted side effects on the skin, bone, blood vessels and muscles. It remains unclear as to how steroid treatment causes adverse outcomes on various tissues, and why patients experience different side effects. Therefore, the main aims of the study are to:
  1. explore potential measures/tests that can be used to determine which patients are at risk from experiencing steroid-mediated side effects, and
  2. explore the mechanisms behind how steroid treatment exerts negative side-effects on different tissues, and why the side effects experienced vary between patients.
  The study will be conducted at Chapel Allerton Hospital in Leeds and will consist of two parts. In part one (cross-sectional feasibility), healthy and people with and without inflammatory/autoimmune conditions that might be treated with glucocorticoids (>18 years) will be recruited and will attend at least 2 visits. The aim is to identify which tests are feasible and should be used in part two (longitudinal observational), and for calculation of the sample size required. In part two, patients with an inflammatory disease who have just started steroid treatment and are expected to continue with this for at least 4-6 months, such as GCA and PMR, will be recruited. Participants will visit the hospital for the selected tests, which will be arranged at the start (< 1 month) and approximately 4-6 months from the beginning of steroid treatment. At each testing visit, an array of quantitative, functional and molecular tests will be completed from the blood, skin, bone and musculoskeletal, vascular and endocrine systems.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  14/YH/1147

• Date of REC Opinion

  4 Sep 2014

• REC opinion

  Favourable Opinion