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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
Author(s) -
Tofte N.,
Lindhardt M.,
Adamova K.,
Beige J.,
Beulens J. W. J.,
Birkenfeld A. L.,
Currie G.,
Delles C.,
Dimos I.,
Francová L.,
FrimodtMøller 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.,
Leyen H.,
Rossing P.
Publication year - 2018
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/dme.13669
Subject(s) - medicine , kidney disease , diabetes mellitus , type 2 diabetes , population , creatinine , diabetic nephropathy , renal function , albuminuria , endocrinology , environmental health
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 CKD 273. 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 CKD 273 score. Clinical baseline data for the whole cohort and stratified by risk groups are reported. The associations between CKD 273 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 ( R 2 < 0.04) of CKD 273 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 CKD 273 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 CKD 273. These data suggest that CKD 273 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: Eudra CT 2012‐000452‐34 and Clinicaltrials.gov: NCT 02040441).