THE BOX FAMILY STUDY: (BOX 3) Version 1
Research type
Research Study
Full title
THE BART’S-OXFORD FAMILY STUDY OF CHILDHOOD DIABETES:\nLONGITUDINAL AND MULTI-GENERATIONAL ANALYSIS OF A CHANGING DISEASE (BOX 3)\n
IRAS ID
167868
Contact name
Kathleen Gillespie
Contact email
Sponsor organisation
University of Bristol
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
BOX is a population based observational study ongoing since 1985. It has made crucial contributions documenting the immune process which leads to clinical symptoms of Type 1 diabetes (T1D). The genes and immune characteristics of this condition are changing. This will alter how people shown to be at increased risk of T1D are identified for clinical trials aimed at prevention. It is becoming clear that the process leading to T1D is extremely complex and improved understanding of the mechanisms underlying these differences is required. \n\nThis application describes continued new family recruitment; the extension of current BOX study cohorts recruited since 1985; expansion into the next generation; first and second degree relatives of the proband. This will facilitate studying the natural history of T1D and related autoimmune conditions. \n\nOur proposed research protocol is split into two stages: \nIn stage one, families of newly diagnosed children/young adults will complete a registration questionnaire and will have samples collected i.e venous/capillary blood (T1D genes, autoantibodies), urine (C-peptide) and mouth swab (T1D genes). Retrospective invitations to first and second degree relatives of the proband will be sent and informed consent taken to participate in stage one. \n\nIn stage two, all recruited participants that are found to have islet autoantibody markers (plus a negative control population) who consent to continue, will be under active follow up to measure in detail how their insulin producing cells are functioning. Annual Oral Glucose Tolerance Tests (OGTT) will be offered and participants’ will have a dedicated Research Nurse to give information and support through this process. Further blood, urine and faecal (stool) samples will be requested to investigate the initiation and progression of islet autoimmunity.\n\nOur overall objective is to study the natural History of T1D including the initiation and progression of autoimmunity through generations of each family. [COVID-19 amendment 10/07/2020]; Introducing a new COVID-19 substudy to test immune markers and collect questionnaire data to discover more about how the SARS-Cov-2 virus affects participants. This research will only be implemented at the academic site in Bristol only (BOX coordinating Centre). BOX 3 end date extended due to UK pandemic.\n\n\n
REC name
South Central - Oxford C Research Ethics Committee
REC reference
15/SC/0310
Date of REC Opinion
27 Jul 2015
REC opinion
Further Information Favourable Opinion