DONATE Study
Research type
Research Study
Full title
DONATE Study: A single site, observational pilot study evaluating the role of DonOr Nephrectomy and renAl Transplant on insulin sensiTivity and mEtabolic acidosis
IRAS ID
277816
Contact name
M Yaqoob
Contact email
Sponsor organisation
Organisation Director of Research Services & Business Development
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
We have previously shown that chronic kidney disease (CKD) is a prediabetic state with marked insulin resistance (IR) - decreased ability of the body to utilize insulin. Recently in an experimental high fat diet induced IR we have identified that nephrectomy (removal of the kidney) induced mild CKD is associated with improvement in IR with marked reduction in hepatic steatosis (fatty liver). We intend to investigate whether experimental findings are reproducible in clinical setting. In the donor sub-study, we would like to study if kidney donation (nephrectomy) is associated with changes in the ability to utilize insulin (improved insulin sensitivity)? For the donor sub-study, potential donors who fulfil the criteria for kidney donation will be eligible.
In kidney transplant recipients, some have build-up of acid in their blood (acidosis). In CKD, acidosis is associated with IR. We would like to observe if treatment of the acidosis results in improvement in insulin sensitivity. For the recipient sub-study, patients who have received a transplant more than a year ago will be eligible and will be divided into groups depending on the presence and absence of metabolic acidosis. The ones with acidosis will be given sodium bicarbonate as part of routine clinical care. In the transplant sub-study, we would like to compare the change in insulin resistance at 0 and 3 months in the groups with and without acidosis and see if correcting the acidosis changes the insulin resistance.
This will be conducted at a single site where the operations of kidney donation and renal transplant occur – Royal London Hospital, Barts Health NHS Trust. The follow up period after baseline blood tests is 3 months. The entire study will last for up to 2 years.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
21/NE/0126
Date of REC Opinion
2 Aug 2021
REC opinion
Further Information Favourable Opinion