Validating a “from blood’ Type 1 Diabetes Genetic Risk Score (T1D-GRS)
Research type
Research Study
Full title
Validating a ‘From Blood’ Type 1 Diabetes Genetic Risk Score (T1D-GRS) Assay (FBA study)
IRAS ID
277722
Contact name
Jonathan Locke
Contact email
Sponsor organisation
University of Exeter
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Determining whether an individual has type 1 diabetes or type 2 diabetes has important implications for their clinical management and treatment. We have developed a test that calculates a Type 1 Diabetes Genetic Risk Score (T1D-GRS). Our DNA is made up of 4 chemical bases called adenine (A), guanine (G), cytosine (C), and thymine (T), and these 4 letters (A,C,G,T) are the 'alphabet' that our cells use to make proteins and function. At certain positions within our DNA the letter present can differ from person-to-person and this T1D-GRS test determines which of the DNA ‘letters’ are present at 10 positions.
At the moment the T1D-GRS can only be calculated in specialist genetics labs which can extract purified DNA from a routine blood sample. We are now working in collaboration with a company called Randox Laboratories to develop a ‘from blood’ test to determine the T1D-GRS. Before we can use this new test on patients diagnosed with diabetes, we need to show that it works and can identify these specific changes in blood samples from people without diabetes. Using a small number of samples we had, we have shown that the test can correctly identify the variants present. However, some of the ‘letter’ variants are rare and so not present in the samples tested. We now need to focus our testing on these rarer changes.
To do this we need a need a one-off blood sample from people who we know (as we have previously tested their purified DNA) have only one of these rare ‘letter’ variants. We will then be able to use our new direct ‘from blood’ test to see if it gives us the same result as determined previously.
If blood rather than pure DNA can be used to determine the T1D-GRS, it means the test could be used in general clinical chemistry laboratories where other routine tests for type 1 diabetes (autoantibodies) are undertaken, leading to improved speed and accuracy of diagnosis.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
20/NW/0154
Date of REC Opinion
26 Mar 2020
REC opinion
Favourable Opinion