Testosterone reference range study
Research type
Research Study
Full title
Study to determine the reference range for testosterone measurement in both non-diabetic and diabetic males.
IRAS ID
182542
Contact name
Laura Lewis
Contact email
Sponsor organisation
Heart of England NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
A reference range for a substance defines the range of values which 95% of normal people will fall into. A value outside of the reference range could be indication of a pathological condition which may require further action or treatment. It is paramount that reference ranges accurately reflect the normal population. The current reference range used by Heart of England NHS Foundation Trust for measurement of total testosterone is that given by the test kit manual. There is concern that the lower limit of this range may be a too low and that people in this region may require treatment. There is also concern that interferences may occur within the lower range of the test and it therefore might not be giving accurate results.
This project involves validation of this reference range. We aim to gather blood samples from 150 healthy males from the local population with normal sexual function (and therefore presumably ‘normal’ testosterone concentrations). We also want to validate a testosterone reference range for diabetic males. Diabetic males often have decreased testosterone production. However, it is unclear whether this leads to a pathological outcome. We therefore also want to validate a testosterone reference range for diabetics. Samples will be collected from 150 diabetic males from the local population with normal sexual function.
Evidence exists that testosterone measurements vary between ethnicities. Investigation into ethnicity-specific reference ranges could prove beneficial. The samples from the above collections will be used to investigate this.
The testosterone assay gives a value for total testosterone concentration. We would like to establish our own method for the measurement of free testosterone and use this to derive our own equation for free testosterone estimation from total testosterone to give more accurate calculations of free testosterone for our given population.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
15/WM/0384
Date of REC Opinion
4 Dec 2015
REC opinion
Further Information Favourable Opinion