Characteristics of high- and low-risk individuals in the PRIORITY study: urinary proteomics and mineralocorticoid receptor antagonism for prevention of diabetic nephropathy in Type 2 diabetes

Tofte, N. et al. (2018) Characteristics of high- and low-risk individuals in the PRIORITY study: urinary proteomics and mineralocorticoid receptor antagonism for prevention of diabetic nephropathy in Type 2 diabetes. Diabetic Medicine, 35(10), pp. 1375-1382. (doi: 10.1111/dme.13669) (PMID:29781558)

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Aim: To compare clinical baseline data in individuals with Type 2 diabetes and normoalbuminuria, who are at high or low risk of diabetic kidney disease based on the urinary proteomics classifier CKD273. Methods: We conducted a prospective, randomized, double‐blind, placebo‐controlled international multicentre clinical trial and observational study in participants with Type 2 diabetes and normoalbuminuria, stratified into high‐ or low‐risk groups based on CKD273 score. Clinical baseline data for the whole cohort and stratified by risk groups are reported. The associations between CKD273 and traditional risk factors for diabetic kidney disease were evaluated using univariate and logistic regression analysis. Results: A total of 1777 participants from 15 centres were included, with 12.3% of these having a high‐risk proteomic pattern. Participants in the high‐risk group (n=218), were more likely to be men, were older, had longer diabetes duration, a lower estimated GFR and a higher urinary albumin:creatinine ratio than those in the low‐risk group (n=1559, P<0.02). Numerical differences were small and univariate regression analyses showed weak associations (R2 < 0.04) of CKD273 with each baseline variable. In a logistic regression model including clinical variables known to be associated with diabetic kidney disease, estimated GFR, gender, log urinary albumin:creatinine ratio and use of renin‐angiotensin system‐blocking agents remained significant determinants of the CKD273 high‐risk group: area under the curve 0.72 (95% CI 0.68–0.75; P<0.01). Conclusions: In this population of individuals with Type 2 diabetes and normoalbuminuria, traditional diabetic kidney disease risk factors differed slightly between participants at high risk and those at low risk of diabetic kidney disease, based on CKD273. These data suggest that CKD273 may provide additional prognostic information over and above the variables routinely available in the clinic. Testing the added value will be subject to our ongoing study. (European Union Clinical Trials Register: EudraCT 2012‐000452‐34 and NCT02040441).

Item Type:Articles
Glasgow Author(s) Enlighten ID:Delles, Professor Christian and Currie, Dr Gemma
Authors: Tofte, N., Lindhardt, M., Adamova, K., Beige, J., Beulens, J. W. J., Birkenfeld, A. L., Currie, G., Delles, C., Dimos, I., Francová, L., Frimodt-Møller, M., Girman, P., Göke, R., Havrdova, T., Kooy, A., Mischak, H., Navis, G., Nijpels, G., Noutsou, M., Ortiz, A., Parvanova, A., Persson, F., Ruggenenti, P. L., Rutters, F., Rychlík, I., Spasovski, G., Speeckaert, M., Trillini, M., von der Leyen, H., and Rossing, P.
College/School:College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
Journal Name:Diabetic Medicine
ISSN (Online):1464-5491
Published Online:21 May 2018
Copyright Holders:Copyright © 2018 Diabetes UK
First Published:First published in Diabetic Medicine 35(10): 1375-1382
Publisher Policy:Reproduced in accordance with the publisher copyright policy

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
573932PRIORITY: Intervention study for the prevention of diabetic nephropathyChristian DellesEuropean Commission (EC)279277RI CARDIOVASCULAR & MEDICAL SCIENCES