Validation of HOMAtx
Research type
Research Study
Full title
Validation Study of Homeostasis Model Assessment for Pancreas Transplantation
IRAS ID
164865
Contact name
Stephen Gough
Contact email
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Diabetes is a common condition affecting the pancreas resulting in considerable complications for sufferers. Pancreas transplantation is an effective treatment for patients with type 1 diabetes. Unfortunately, it is common after pancreas transplantation for the pancreas graft to stop working, and we do not have an established method for monitoring pancreas graft function. Oral glucose tolerance tests can be used, but are inconvenient for patients and may not pick up small changes. If we had an easy and accurate way of monitoring how well pancreas grafts work, we would be able to detect pancreas grafts that are not functioning properly early enough to intervene and possibly prevent it failing.
The hyperglycaemic glucose clamp can be used to assess beta cell function and insulin sensitivity. However, it is laborious involving frequent blood sampling, making its use unfeasible in routine clinical practice. The Homeostasis Model Assessment (HOMA) was developed as a simple objective measure of beta-cell function. However, the HOMA calculation cannot be used in pancreas transplantation because the way the pancreas is plumbed in changes the way glucose and insulin are processed by the body. We have modified the HOMA calculation to adjust for the differences we see in pancreas transplantation to make a new model. We hope that this model could be used to assess pancreas graft function easily in follow-up clinics after pancreas transplantation. However, before we can do this, we will need to validate the model against the standard test, the hyperglycaemic glucose clamp.
We will complete hyperglycaemic glucose clamps in 12 pancreas transplant recipients and compare the results to the new HOMA model. We will also complete hyperglycaemic glucose clamps in 12 healthy volunteers and compare the results to the established HOMA model. All participants will also an oral glucose tolerance test. This is so that we can later categorise participants into groups according to their glucose tolerance.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
14/SC/1406
Date of REC Opinion
26 Jan 2015
REC opinion
Further Information Favourable Opinion