FIND IT 2

  • Research type

    Research Study

  • Full title

    The effect of Finasteride/Dutasteride & Prednisolone on metabolic (Insulin) action in healthy volunteers (FindIt2)

  • IRAS ID

    149952

  • Contact name

    Jeremy Tomlinson

  • Contact email

    jeremy.tomlinson@ocdem.ox.ac.uk

  • Sponsor organisation

    Oxford University Hospitals NHS Foundation Trust

  • Duration of Study in the UK

    0 years, 10 months, 29 days

  • Research summary

    Natural steroid hormones in the human body have potent actions to regulate carbohydrate and lipid metabolism. We have shown that the activity of an enzyme that regulates steroid hormone levels, called 5areductase,increases as patients gain weight and decreases with weight loss. In cultured cells we have also shown that increases in the activity of 5areductase may lead to enhanced lipid accumulation. We will conduct a clinical study that will aim to demonstrate the impact that inhibition of 5areductase activity has upon metabolism in healthy volunteers. We will use 2 different 5areductase inhibitors (Finasteride and Dutasteride). The purpose of this study is to see if this enzyme, 5aR is important in controlling how the body handles carbohydrate and lipid. We believe that 5aReductase is a crucial step in regulating these actions as well as controlling how insulin works in the body. We will also use a steroid hormone (prednisolone) as a comparison. Importantly, these drugs are already widely used in clinical practice today for other indications. Healthy male volunteers will be recruited for this study and will take the study drug for 7 days.
    We will carry out a number of tests before and after taking the study drugs including collecting urine for 24 hours, fasting blood tests and biopsies of fat from the belly button area and buttock. We will also perform a test called a clamp study. This involves infusions of insulin and glucose over 6 hours with regular glucose and blood testing. All tests will be performed by experienced nursing and medical personnel.

  • REC name

    Wales REC 7

  • REC reference

    15/WA/0071

  • Date of REC Opinion

    27 Feb 2015

  • REC opinion

    Favourable Opinion