ADDRESS C-Peptide
Research type
Research Study
Full title
ADDRESS C-Peptide: Validation and assessment of urine C-peptide to creatinine ratio as a measure of beta cell function in a multi-ethnic new-onset type 1 diabetes cohort
IRAS ID
221012
Contact name
Desmond Johnston
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
0 years, 8 months, 8 days
Research summary
At diagnosis of type 1 diabetes (T1D), many people still make some insulin in their own bodies and this declines over time. In this sub-study of the ADDRESS-2 study we want to investigate how the ability to make insulin changes during the first year after diagnosis in children and adults. We want to find out how it varies with other characteristics of T1D. Understanding this better might help to identify people in the future who are best-suited to new treatments for T1D.
To assess insulin production we measure C-peptide, but different methods can be used. We want to investigate whether C-peptide measured in a urine sample collected at home after an evening meal is a valid and practical method for people recently diagnosed with T1D.
This study is for participants in the ADDRESS-2 study and has 2 branches:
Branch 1 is for children and adults aged 5 years or older with T1D for less than 6 months. We will ask them (with parents help, if children) to provide 2 urine home samples for measurement of C-peptide and to answer a questionnaire at up to 3 time points from diagnosis: 3, 6 and 12 months.
Branch 2 is for adults aged 18 years or older with T1D for less than 12 months. We will ask them to provide urine samples and to attend a single study appointment after an overnight fast, to receive a standardised liquid meal, after which a series of blood samples will be taken for measurement of C-peptide. This is called the mixed meal tolerance test (MMTT). We will compare C-peptide measured in urine and in blood during the MMTT. We will include 29 people from different ethnic groups: 19 White European, 5 South Asian, and 5 Black African/Caribbean.It is being funded by Diabetes UK and the Juvenile Diabetes Research Foundation.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0120
Date of REC Opinion
27 Mar 2017
REC opinion
Favourable Opinion