HOMAtx validation - sensitivity assessment
Research type
Research Study
Full title
Validation Study of Homeostasis Model Assessment for Pancreas Transplantation – Sensitivity Assessment
IRAS ID
241920
Contact name
Shruti Mittal
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Diabetes is a common condition affecting the pancreas, resulting in loss of insulin-producing beta-cells. This results in loss of control of blood sugar levels. Pancreas transplantation is an established and effective treatment for patients with type 1 diabetes. Donor pancreases are transplanted into patients with difficult to manage diabetes or advanced complications, giving them insulin independence and resulting in stabilisation of diabetic complications, improved quality of life, and improved life expectancy. Unfortunately, pancreas graft failure after transplantation is common and there is a lack of established predictors to identify those grafts at the highest risk. By the time regulation of blood sugar has become sufficiently impaired to be detected using current methods, it is too late to rescue the transplanted pancreas. This study aims to validate a new model, called HOMAtx, for predicting graft dysfunction earlier than is currently possible. The model encompasses two parts - assessment of the capacity of the transplanted pancreas to secrete insulin, and assessment of the sensitivity of the rest of the body to that insulin. We have already demonstrated that the insulin secretion part of the model is valid; with this present study, we aim to validate the sensitivity part of this model.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0480
Date of REC Opinion
31 Jul 2018
REC opinion
Further Information Favourable Opinion