Understanding beta-cell destruction through the study of EXtremely Early-onset Type 1 Diabetes

 Early-onset Type 1 Diabetes / Posted 1 year ago

A study to assess clinical phenotype, beta cell function, genetics, and autoantibodies in Extremely Early Type 1 Diabetes (EET1D) to better understand the aetiology and progression of beta cell destruction in Type 1 diabetes (T1D) occurring in the first year of life. As a study of a very rare disease ( < 100 in UK) defined by genetics, it is adopted as a Musketeers’ Memorandum Study.

  • Inclusion Criteria : Study 1: EET1D
    • Aged 0 to 70 years
    • Clinical diagnosis of diabetes less than 12 months(+ evidence of WHO diabetes criteria)
    • Negative genetic test for mutations causing neonatal diabetes
    • Type 1 diabetes genetic risk score greater than 50th centile of T1D reference group. T1D Controls
    • Age 0-70 years (matched to above)
    • Clinical diagnosis of T1D (diagnosed age 1-20 years)
    • Insulin treated from diagnosis. Study 2: EET1D
    • Aged 0 to 18 months at recruitment
    • Clinical diagnosis of diabetes less than 12 months (+ evidence of WHO diabetes criteria)
    • Negative genetic test for mutations causing neonatal diabetes
    • Type 1 diabetes genetic risk score greater than 50th centile of T1D reference group NDM controls
    • Diagnosis of diabetes less than 12 months
    • Age 0 to 18 months at recruitment
    • Diagnosis of NDM (confirmed by Exeter Molecular Genetics Service).
  • Exclusion Criteria : Study 1:
    • Aged more 70 years
    • No diagnosis of diabetes
    • Non-T1D, such as MODY, type 2 diabetes or diabetes related to pancreatic insufficiency or syndromic diabetes
    • Intercurrent illness at time of sampling for PBMCs (see below). Study 2:
    • Aged more than 18 months
    • Clinical diagnosis of diabetes more than 14 months
    • Inter-current illness at time of sampling for PBMCs or RNA (see below). For PBMC and RNA sampling: Exclusion for factors that may alter T cell function and RNAseq Review the following exclusion criteria carefully at time of appointment as some details may have changed since initial contact:
    • Recreational drug use (excluding cannabis use more than 1 week prior to blood sampling) - drug abuse may alter T cell function
    • Alcohol related illness (excessive alcohol consumption may alter T cell function)
    • Renal failure: Creatinine greater than 200 (as may alter T cell function)
    • Any other medical condition which, in the opinion of the investigator, would affect the safety of the subjects participation.
    • Factors that if temporary would lead to rearrangement of study visit but if long duration, may lead to exclusion subject to the CI’s discretion:
    • Pregnant or lactating (as this may limit blood sampling and affect T cell function)
    • Any infectious illness within the last 2 weeks if it was a febrile illness, or within 2-3 days if it was non-febrile (as this may activate T cells non-specifically)
    • Taking steroids or other immunosuppressive medications (as these may alter T cell function)
    • Received any immunoglobulin treatments or blood products in the last 3 months (as these may alter T cell function).
  • Study start date : 01/09/2017
  • Study end date : 28/02/2021
  • Wales-Based Study Contact : please speak to your clinician
  • Principal Investigator : Julian Sampson
Contact details
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