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Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy In TYpe 2 diabetic patients with normoalbuminuria

Objective

Patients with diabetes are at risk of developing diabetic nephropathy, which will ultimately result in the requirement for renal replacement therapy and is also associated with high cardiovascular morbidity and mortality. Detection of low concentrations of albuminuria in urine (microalbuminuria) is the current clinical standard for detecting those at significant risk and targeting preventive treatment. However, albuminuria is of low specificity at early stages of disease, and of considerable biological variability, hence a poor predictor at early stages of disease. In two independent studies we have demonstrated that urinary proteomics offers the prospect of detecting nephropathy earlier in the preclinical phase, enabling targeted treatment at an earlier stage. We propose to assess the potential of this technology to identify normoalbuminuric patients at risk and to target therapy with an aldosterone receptor antagonist (spironolactone) as add-on to recommended therapy including angiotensin converting enzyme (ACE) inhibition or angiotensin II receptor blockers (ARBs) according to national guidelines. We will test the following hypotheses: (1) urinary proteomics predicts progression of albuminuria (as a surrogate marker for the development of overt nephropathy) in a cohort of 3280 type 2 diabetic patients with normal urinary albumin excretion, and (2) early initiation of intensive preventive therapy directed by urinary proteomics reduces progression of albuminuria in those 20 % at high risk and thereby delay progression to overt nephropathy and spare treatment for those with low risk, paving the way of personalised medicine. This will be the first biomarker-directed therapy trial for primary prevention of diabetic kidney disease. Additional clinical and circulating biomarkers will be assessed and models to predict progression of albuminuria including clinical factors, biomarkers and proteomics will be developed.

Call for proposal

FP7-HEALTH-2011-two-stage
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

REGION HOVEDSTADEN
Address
Kongens Vaenge 2
3400 Hillerod
Denmark
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
EU contribution
€ 438 930,70
Administrative Contact
Maria Athena Campbell (Mrs.)

Participants (21)

MOSAIQUES DIAGNOSTICS GMBH
Germany
EU contribution
€ 1 499 250
Address
Rotenburger Strasse 20
30659 Hannover
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Harald Mischak (Prof.)
ACADEMISCH ZIEKENHUIS GRONINGEN
Netherlands
EU contribution
€ 210 201
Address
Hanzeplein 1
9713 GZ Groningen
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Gerjan Navis (Prof.)
UNIVERSITY OF GLASGOW
United Kingdom
EU contribution
€ 963 920,40
Address
University Avenue
G12 8QQ Glasgow
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Joe Galloway (Mr.)
ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
Italy
EU contribution
€ 283 830
Address
Via Mario Negri 2
20156 Milano
Activity type
Research Organisations
Administrative Contact
Maria Grazia Pezzoni (Ms.)
UNIVERZITA KARLOVA
Czechia
EU contribution
€ 82 080
Address
Ovocny Trh 560/5
116 36 Praha 1
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Ivan Rychlik (Prof.)
CHARITE - UNIVERSITAETSMEDIZIN BERLIN

Participation ended

Germany
EU contribution
€ 6 686,30
Address
Chariteplatz 1
10117 Berlin
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Eveline Fräßdorf (Ms.)
GENIKO NOSOKOMEIO ATHINAS IPPOKRATEIO
Greece
EU contribution
€ 84 570
Address
Vasilisis Sofias 114
11527 Athina
Activity type
Research Organisations
Administrative Contact
Marina Noutsou (Dr.)
Institut klinické a experimentální mediciny
Czechia
EU contribution
€ 64 940
Address
Videnska 1958/9
14021 Prague 4
Activity type
Research Organisations
Administrative Contact
Petr Boucek (Dr.)
INSTITUTO INVESTIGACION SANITARIA FUNDACION JIMENEZ DIAZ
Spain
EU contribution
€ 25 639,50
Address
Avenida De Los Reyes Catolicos 2
28040 Madrid
Activity type
Research Organisations
Administrative Contact
Alberto Ortiz (Dr.)
RD NEPHROLOGIE SAS

Participation ended

France
EU contribution
€ 9 804,80
Address
2 Rue Des Muriers
34000 Montpellier
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Angel Argiles (Prof.)
KLINIKUM ST GEORG GGMBH
Germany
EU contribution
€ 66 740
Address
Delitzscher Strasse 141
04129 Leipzig
Activity type
Other
Administrative Contact
Joachim Beige (Dr.)
University of Zurich

Participation ended

Switzerland
Address
Ramistrasse 71
8006 Zurich
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Andreas Serra (Dr.)
Ss. CYRIL AND METHODIUS UNIVERSITY IN SKOPJE
North Macedonia
EU contribution
€ 178 250,25
Address
Blvd Goce Delcev 9
1000 Skopje
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Goce Spasovski (Prof.)
HANNOVER CLINICAL TRIAL CENTER GMBH
Germany
EU contribution
€ 850 550,90
Address
Carl Neuberg Str 1 K 27 Oe 9751
30625 Hannover
Activity type
Research Organisations
Administrative Contact
Heiko Von Der Leyen (Prof.)
DIABETES AND VASCULAR RESEARCH FOUNDATION
Netherlands
EU contribution
€ 30 890
Address
Dr.g.h.amshoffweg 1
7900 RA Hoogeveen
Activity type
Research Organisations
Administrative Contact
Adriaan Kooy (Dr.)
UNIVERSITAIR ZIEKENHUIS GENT
Belgium
EU contribution
€ 66 259,99
Address
Corneel Heymanslaan 10
9000 Gent
Activity type
Research Organisations
Administrative Contact
Marijn Speeckaert (Dr.)
GWT-TUD GMBH
Germany
EU contribution
€ 25 910
Address
Blasewitzer Strasse 43
01307 Dresden
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Sandra Krause (Ms.)
STICHTING VU
Netherlands
Address
De Boelelaan 1105
1081 HV Amsterdam
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Femke Rutters (Ms.)
DIABETOLOGEN HESSEN EG
Germany
EU contribution
€ 61 740
Address
Liebigstrasse 20
35392 Giessen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Reinhold Preiss (Mr.)
STICHTING VUMC
Netherlands
EU contribution
€ 149 958
Address
De Boelelaan 1117
1081 HV Amsterdam
Activity type
Research Organisations
Administrative Contact
Yvonne Koppelman (Mrs.)
NOVO NORDISK INVEST 4 A/S

Participation ended

Denmark
EU contribution
€ 880 348,16
Address
Novo Alle 1
2880 Bagsvaerd
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Peter Rossing (Dr.)