UCPCR Study V1.0
Research type
Research Study
Full title
Urinary C-peptide:creatinine ratio as a marker of graft function in pancreas transplantation
IRAS ID
183156
Contact name
James Barnes
Contact email
Sponsor organisation
Buckinghamshire NHS Trust
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Urinary C-peptide:creatinine ratio as a marker of graft function in pancreas transplantation.
Kidney failure, eye disease, nerve damage and advanced cardiovascular disease are devastating complications for some patients with diabetes (up to 30% of patients develop impaired vision). Evidence suggests that pancreatic transplantation can be highly effective in helping these patients but the benefits require the pancreas graft to function for many years. However early transplant failure is common, largely because there is no effective way to monitor the graft for signs of failure until the damage is irreversible.
C-peptide is a protein that is released by the pancreas and has been shown to be a useful marker of pancreas function in other groups of patients with diabetes. It is cleared from the body by the kidneys and therefore other studies have shown that a urine test of C-peptide:creatinine ratio could demonstrate pancreas function. However, there is no evidence to support the accuracy or use of urinary C-peptide in patients that have had a pancreas transplant.
This study aims to investigate whether urinary C-peptide:creatinine ratio can be used to monitor pancreas function after transplantation but also whether this can be translated into a simple home-based urine test.
The study is being funded by both the NIHR Oxford BRC and Professor Gough’s research funds. It will take place at the Clinical Research Unit in the Oxford Centre for Diabetes, Endocrinology and Metabolism at the Churchill Hospital in Oxford.
Participants will be recruited after pancreas transplantation. The first part of the study will involve 3 visits over 6 months to have an oral glucose tolerance test. The second part will involve participants sending monthly urine samples from home over the 6 month duration of the study.REC name
South Central - Oxford B Research Ethics Committee
REC reference
15/SC/0413
Date of REC Opinion
3 Aug 2015
REC opinion
Further Information Favourable Opinion