C-pepT1D study

• Research type

  Research Study

• Full title

  Evaluation of a novel method that measures beta-cell function by dried blood spots in children and adolescents with a recent diagnosis of type 1 diabetes (C-pepT1D)

• IRAS ID

  144560

• Contact name

  David B Dunger

• Contact email

  dbd25@cam.ac.uk

• Research summary

  Background: In type 1 diabetes (T1D) the body's own immune system destroys the insulin-producing beta-cells. At diagnosis, a small number of beta-cells is left which still produce insulin (beta-cell function). Residual beta-cell function (BCF) can be measured by C-peptide, a peptide which is produced simultaneously with insulin. Most diabetes patients eventually lose the ability to produce insulin themselves. However, the longer they maintain this ability, the better it is for the control of their sugar levels and long-term complications. C-peptide measurement is normally not implemented in routine care because it is laborious to measure. However, we have helped to develop a new method to measure C-peptide in 'dried blood spots’ (DBS), could be very useful for future intervention studies aimed to preserve BCF.
  Hypothesis: BCF can be tracked over time by means of DBS C-peptide measurement and the results will be comparable to the current golden standard Mixed Meal Tolerance Test (MMTT).
  Subjects: 30 Children and adolescents 5-18 yrs with a diagnosis of T1D in the last 6 months
  Primary Objective: To evaluate the correlation between DBS and venous C-peptide samples
  Secondary objectives:
  1. To track C-peptide changes over time by means of DBS C-peptide samples taken at home
  2. To evaluate the correlation of the change in ß-cell function over time between the DBS and venous C-peptide method
  3. To evaluate intra- and inter-assay coefficients of variation of the DBS C-peptide method
  4. To evaluate the correlation between ß-cell function assessed by post-prandial urinary C-peptide/creatinine ratio and venous C-peptide samples
  Exploratory objectives:
  1. To explore relationships between ß-cell function and lipidomics measured in DBS
  2. To identify predictors for the rate of decline in ß-cell function
  3. To identify the relationship between ß-cell function and immune markers
  

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  14/EE/1042

• Date of REC Opinion

  8 Sep 2014

• REC opinion

  Further Information Favourable Opinion