INNODIA – People at Increased Risk

Recruiting until: End of Sep 2023

Recruiting sites:

  • Cambridge University Hospitals NHS Foundation Trust (Adults and Children)
  • Barts Health NHS Trust (Children plus parents)
  • Northampton General NHS Trust (Adults and Children)
  • West Suffolk NHS Foundation Trust (Children plus parents)
  • Birmingham Childrens Hospital (Children)
  • NHS Fife – Victoria Hospital (Adults and Children)
  • Oxford University Hospital NHS Foundation Trust (Adults)
  • University Hospital of Wales (Adults)
  • Sheffield Teaching Hospitals NHS Foundation Trust (pending) (Adults)
  • Royal Infirmary Edinburgh (Adults)
  • Nottingham University Hospital NHS Trust (Adults and Children)

Summary:

A project throughout Europe which collects blood samples and data from first degree relatives (brothers, sisters, parents or children) of a person with T1D or from those who have been told by another study that they have either a genetic risk or have tested positive for T1D autoantibodies which put them at increased risk of developing T1D .

Aim

The purpose of the study is to identify people who are at increased risk of developing T1D and monitor them for two years to see who progresses to T1D. We know that relatives (brothers, sisters, children and parents) share some genes with their family member with T1D and therefore may be at greater risk of developing T1D. We also know that 84% of individuals with 2 or more autoantibodies will develop T1D in the next 15 years. It is uncommon for individuals with only 1 autoantibody to progress to T1D unless they develop more autoantibodies later on.

One way of checking if you are at greater risk of developing T1D is by taking a small blood sample to look at your genes and to measuring autoantibodies in the blood. Antibodies are a type of protein produced by cells of the immune system. Autoantibodies can attack healthy cells in the body because they recognise them as ‘foreign’ cells. We are looking to identify people who have 2 or more autoantibodies detected in their blood and invite them for longterm follow up over two years.

Contact us

Email: innodia-recruit@paed.cam.ac.uk

www.innodia.eu

Eligibility to take part

  1. Age 1 to <45 years
  2. Have a first degree relative with T1D or have been identified as at high risk of developing T1D.

If you are interested in taking part, please click the “Get Involved” button below:

What will I be asked to do?

We will ask you to attend a screening visit which will take about one hour, where a sample of your blood will be taken for genes and autoantibody testing. We will also ask about your medical and family history.

People who have 2 or more positive autoantibodies, will be invited back for a further 5 visits spread over 2 years. These visits will involve asking about your medical history, family medical history and taking measurement such as height and weight. Blood samples will be taken to measure C-peptide, HbA1c and biomarkers of beta cell function. An oral glucose tolerance test will also be carried out at each visit.

For those who are negative or have 1 positive autoantibody, we may ask you to provide further samples to compare with people who have T1D. We will also keep you informed of other studies.

If you have one positive autoantibody we may invite you for a rescreen after 2 years to see if anything has changed, it is up to you if you accept this invitation.

Who is running this study?

This study is sponsored by Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge UK. Chief Investigator: Dr Emile Hendriks, University of Cambridge Assistant Professor.

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115797 (INNODIA). This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and European Federation of Pharmaceutical Industries and Associations (EFPIA), Juvenile Diabetes Research Foundation (JDRF) and The Leona M. and Harry B. Helmsley Charitable Trust.