• Something wrong with this record ?

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

N. Tofte, M. Lindhardt, K. Adamova, J. Beige, JWJ. Beulens, AL. Birkenfeld, G. Currie, C. Delles, I. Dimos, L. Francová, M. Frimodt-Møller, P. Girman, R. Göke, T. Havrdova, A. Kooy, H. Mischak, G. Navis, G. Nijpels, M. Noutsou, A. Ortiz, A....

. 2018 ; 35 (10) : 1375-1382. [pub] 20180606

Language English Country England, Great Britain

Document type Journal Article, Multicenter Study, Observational Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc19012656

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 Clinicaltrials.gov: NCT02040441).

1st Department Charles University 3rd Faculty of Medicine Prague Czech Republic

1st Department Charles University 3rd Faculty of Medicine Prague Czech Republic Faculty Hospital Královské Vinohrady Prague Czech Republic

Amsterdam Public Health Research Institute VU University Medical Centre Amsterdam The Netherlands

Amsterdam Public Health Research Institute VU University Medical Centre Amsterdam The Netherlands Julius Centre for Health Sciences and Primary Care University Medical Centre Utrecht Utrecht The Netherlands

Bethesda Diabetes Research Centre Hoogeveen and University Medical Centre Groningen Netherlands

Clinical Study Centre Metabolic Vascular Medicine GWT TU Dresden GmbH Dresden Germany Paul Langerhans Institute Dresden of the Helmholtz Centre Munich at University Hospital and Faculty of Medicine TU Dresden Dresden Germany German Centre for Diabetes Research Neuherberg Germany

Department General Practice and Elderly Care Amsterdam Public Health VU University Medical Centre Amsterdam The Netherlands

Department of Nephrology Cyril and Methodius University in Skopje Skopje Macedonia

Diabetes Centre and 2nd Department of Internal Medicine National and Kapodistrian University of Athens Hippokratio General Hospital Athens Greece

Diabetes Centre Institute for Clinical and Experimental Medicine Prague Czech Republic

Diabetespraxis Leipzig Germany

Diabetologische Schwerpunktpraxis Diabetologen Hessen Marburg Germany

Division of Nephrology Department of Internal Medicine University Medical Centre Groningen Groningen Netherlands

Ghent University Hospital Department of Nephrology Ghent Belgium

Hannover Clinical Trial Centre Hannover Germany

Institute of Cardiovascular and Medical Sciences University of Glasgow Glasgow UK

Instituto de Investigacion Sanitaria de la Fundacion Jiménez Díaz UAM Madrid Spain

Istituto di Richerche Farmacologiche Mario Negri Bergamo Italy

Klinikum St Georg Nephrology and KfH Renal Unit Leipzig Martin Luther University Halle Wittenberg Germany

Mosaiques Diagnostics Hannover Germany

Steno Diabetes Centre Copenhagen Gentofte Denmark

Steno Diabetes Centre Copenhagen Gentofte Denmark University of Copenhagen Copenhagen Denmark

University Clinic of Endocrinology Diabetes and Metabolic Disorders Skopje Macedonia

References provided by Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc19012656
003      
CZ-PrNML
005      
20190411104255.0
007      
ta
008      
190405s2018 enk f 000 0|eng||
009      
AR
024    7_
$a 10.1111/dme.13669 $2 doi
035    __
$a (PubMed)29781558
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a enk
100    1_
$a Tofte, N $u Steno Diabetes Centre Copenhagen, Gentofte, Denmark.
245    10
$a 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 / $c N. Tofte, M. Lindhardt, K. Adamova, J. Beige, JWJ. Beulens, AL. Birkenfeld, G. Currie, C. Delles, I. Dimos, L. Francová, M. Frimodt-Møller, P. Girman, R. Göke, T. Havrdova, A. Kooy, H. Mischak, G. Navis, G. Nijpels, M. Noutsou, A. Ortiz, A. Parvanova, F. Persson, PL. Ruggenenti, F. Rutters, I. Rychlík, G. Spasovski, M. Speeckaert, M. Trillini, H. von der Leyen, P. Rossing,
520    9_
$a 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 Clinicaltrials.gov: NCT02040441).
650    _2
$a mladiství $7 D000293
650    _2
$a dospělí $7 D000328
650    _2
$a senioři $7 D000368
650    _2
$a diabetes mellitus 2. typu $x komplikace $x farmakoterapie $x metabolismus $x moč $7 D003924
650    _2
$a diabetické nefropatie $x diagnóza $x metabolismus $x prevence a kontrola $x moč $7 D003928
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a lidé $7 D006801
650    _2
$a hypoglykemika $x terapeutické užití $7 D007004
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a antagonisté mineralokortikoidních receptorů $x terapeutické užití $7 D000451
650    _2
$a prognóza $7 D011379
650    _2
$a proteom $x analýza $x metabolismus $7 D020543
650    _2
$a proteomika $x metody $7 D040901
650    _2
$a hodnocení rizik $7 D018570
650    _2
$a analýza moči $x metody $7 D016482
650    _2
$a mladý dospělý $7 D055815
655    _2
$a časopisecké články $7 D016428
655    _2
$a multicentrická studie $7 D016448
655    _2
$a pozorovací studie $7 D064888
655    _2
$a randomizované kontrolované studie $7 D016449
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Lindhardt, M $u Steno Diabetes Centre Copenhagen, Gentofte, Denmark.
700    1_
$a Adamova, K $u University Clinic of Endocrinology, Diabetes and Metabolic Disorders, Skopje, Macedonia.
700    1_
$a Beige, J $u Klinikum St. Georg, Nephrology and KfH Renal Unit, Leipzig, Martin-Luther University Halle, Wittenberg, Germany.
700    1_
$a Beulens, J W J $u Amsterdam Public Health Research Institute, VU University Medical Centre, Amsterdam, The Netherlands. Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands.
700    1_
$a Birkenfeld, A L $u Clinical Study Centre Metabolic Vascular Medicine, GWT TU-Dresden GmbH, Dresden, Germany. Paul Langerhans Institute Dresden of the Helmholtz Centre Munich at University Hospital, and Faculty of Medicine, TU Dresden, Dresden, Germany. German Centre for Diabetes Research (DZD e.V.), Neuherberg, Germany.
700    1_
$a Currie, G $u Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
700    1_
$a Delles, C $u Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
700    1_
$a Dimos, I $u Diabetespraxis, Leipzig, Germany.
700    1_
$a Francová, L $u 1st Department, Charles University, Third Faculty of Medicine, Prague, Czech Republic.
700    1_
$a Frimodt-Møller, M $u Steno Diabetes Centre Copenhagen, Gentofte, Denmark.
700    1_
$a Girman, P $u Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
700    1_
$a Göke, R $u Diabetologische Schwerpunktpraxis, Diabetologen Hessen, Marburg, Germany.
700    1_
$a Havrdova, T $u Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
700    1_
$a Kooy, A $u Bethesda Diabetes Research Centre, Hoogeveen and University Medical Centre Groningen, Netherlands.
700    1_
$a Mischak, H $u Mosaiques Diagnostics, Hannover, Germany.
700    1_
$a Navis, G $u Division of Nephrology, Department of Internal Medicine, University Medical Centre Groningen, Groningen, Netherlands.
700    1_
$a Nijpels, G $u Department General Practice and Elderly Care, Amsterdam Public Health VU University Medical Centre, Amsterdam, The Netherlands.
700    1_
$a Noutsou, M $u Diabetes Centre and 2nd Department of Internal Medicine, National and Kapodistrian University of Athens, Hippokratio General Hospital, Athens, Greece.
700    1_
$a Ortiz, A $u Instituto de Investigacion Sanitaria de la Fundacion Jiménez Díaz UAM, Madrid, Spain.
700    1_
$a Parvanova, A $u Istituto di Richerche Farmacologiche Mario Negri, Bergamo, Italy.
700    1_
$a Persson, F $u Steno Diabetes Centre Copenhagen, Gentofte, Denmark.
700    1_
$a Ruggenenti, P L $u Istituto di Richerche Farmacologiche Mario Negri, Bergamo, Italy.
700    1_
$a Rutters, F $u Amsterdam Public Health Research Institute, VU University Medical Centre, Amsterdam, The Netherlands.
700    1_
$a Rychlík, I $u 1st Department, Charles University, Third Faculty of Medicine, Prague, Czech Republic. Faculty Hospital Královské Vinohrady, Prague, Czech Republic.
700    1_
$a Spasovski, G $u Department of Nephrology, Cyril and Methodius University in Skopje, Skopje, Macedonia.
700    1_
$a Speeckaert, M $u Ghent University Hospital, Department of Nephrology, Ghent, Belgium.
700    1_
$a Trillini, M $u Istituto di Richerche Farmacologiche Mario Negri, Bergamo, Italy.
700    1_
$a von der Leyen, H $u Hannover Clinical Trial Centre, Hannover, Germany.
700    1_
$a Rossing, P $u Steno Diabetes Centre Copenhagen, Gentofte, Denmark. University of Copenhagen, Copenhagen, Denmark.
773    0_
$w MED00001389 $t Diabetic medicine a journal of the British Diabetic Association $x 1464-5491 $g Roč. 35, č. 10 (2018), s. 1375-1382
856    41
$u https://pubmed.ncbi.nlm.nih.gov/29781558 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20190405 $b ABA008
991    __
$a 20190411104313 $b ABA008
999    __
$a ok $b bmc $g 1391966 $s 1050961
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2018 $b 35 $c 10 $d 1375-1382 $e 20180606 $i 1464-5491 $m Diabetic medicine $n Diabet Med $x MED00001389
LZP    __
$a Pubmed-20190405

Find record

Citation metrics

Logged in users only

Archiving options