Adult beta-cell monitor study
Research type
Research Study
Full title
A study to optimise monitoring of beta-cell destruction in adults with newly diagnosed Type 1 diabetes and high-risk relatives
IRAS ID
216864
Contact name
Danijela Tatovic
Contact email
Sponsor organisation
Cardiff University
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Immunotherapy has the potential to make a paradigm change to the prevention and management of Type 1 diabetes as preservation of even 5% of beta-cell function allows over 50% of people to reach target blood glucose levels. A key limiting factor is the reliance on variable metabolic markers as outcome measures in trials, which provide no insight about changes in the underlying disease process. There is an urgent need to develop biomarkers that can provide early guidance for therapeutic developments in smaller short-term studies, informing larger trials. \n\nCell free (cf) DNA measurement in serum is now well established in cancer to detect residual disease. Beta-cell death is the end product of the autoimmune process that immunotherapy aims to halt. Several laboratories have developed serum assays of demethylated insulin and more recently amylin (both highly expressed in beta-cells) cfDNA, which should be released only from dying beta-cells. For example, these assays provided evidence of a “burst” of beta-cell death around the time of diagnosis.\n\nThe purpose of this project is to validate a highly-specific cfDNA assay for beta-cell death. To achieve this we will correlate the multiple target cfDNA levels with other metabolic, immunological and clinical parameters known to be influenced by the amount of functioning beta-cells in newly diagnosed people with Type 1 diabetes and first degree relatives over the one year long follow-up. Healthy volunteers (people who don’t have Type 1 diabetes or first degree relative with Type 1 diabetes) will be included as controls. \n\nIf proven successful, cfDNA has a potential to emerge as reliable outcome measure in the immunotherapy trials in Type 1 diabetes. \n
REC name
Wales REC 3
REC reference
17/WA/0002
Date of REC Opinion
14 Feb 2017
REC opinion
Further Information Favourable Opinion