E-PREDICE
Early Prevention of Diabetes Complications in people with Hyperglycaemia in Europe
| Coordinatore | FUNDACION DE INVESTIGACION EN RED EN ENFERMEDADES CARDIOVASCULARES
Organization address
address: ALMAGRO 1 contact info |
| Nazionalità Coordinatore | Spain [ES] |
| Sito del progetto | http://www.epredice.eu |
| Totale costo | 8˙254˙923 € |
| EC contributo | 5˙999˙996 € |
| Programma | FP7-HEALTH
Specific Programme "Cooperation": Health |
| Code Call | FP7-HEALTH-2011-two-stage |
| Funding Scheme | CP-FP |
| Anno di inizio | 2012 |
| Periodo (anno-mese-giorno) | 2012-01-01 - 2016-12-31 |
Partecipanti
| # | ||||
|---|---|---|---|---|
| 1 |
FUNDACION DE INVESTIGACION EN RED EN ENFERMEDADES CARDIOVASCULARES
Organization address
address: ALMAGRO 1 contact info |
ES (MADRID) | coordinator | 813˙837.70 |
| 2 |
EVIDEM CONSULTORES SL
Organization address
address: PLAZA DEL ENCUENTRO 1 contact info |
ES (MADRID) | participant | 944˙080.40 |
| 3 |
UNIVERSITA DI PISA
Organization address
address: Lungarno Pacinotti 43/44 contact info |
IT (PISA) | participant | 411˙862.20 |
| 4 |
SERVICIO MADRILENO DE SALUD
Organization address
address: PLAZA CARLOS TRIAS BERTRAN 7 contact info |
ES (MADRID) | participant | 357˙609.60 |
| 5 |
TERVEYDEN JA HYVINVOINNIN LAITOS
Organization address
address: MANNERHEIMINTIE 166 contact info |
FI (HELSINKI) | participant | 254˙690.90 |
| 6 |
INSTITUTO DE INVESTIGACION SANITARIA DE LA FUNDACION JIMENEZ DIAZ
Organization address
address: AVENIDA REYES CATOLICOS 2 contact info |
ES (MADRID) | participant | 248˙400.00 |
| 7 |
UNIVERSIDAD DE VALLADOLID
Organization address
address: PLAZA SANTA CRUZ 8 PALACIO DE SANTA CRUZ contact info |
ES (VALLADOLID) | participant | 200˙000.00 |
| 8 |
TECHNISCHE UNIVERSITAET DRESDEN
Organization address
address: HELMHOLTZSTRASSE 10 contact info |
DE (DRESDEN) | participant | 191˙700.00 |
| 9 |
"FACULTY OF MEDICINE, UNIVERSITY OF BELGRADE"
Organization address
address: "Dr Subotica, 8" contact info |
RS (BELGRADE) | participant | 172˙300.00 |
| 10 |
"FUNDACIO JORDI GOL I GURINA, FUNDACIO PRIVADA PER A LA RECERCA A L'ATENCIO PRIMARIA DE SALUT"
Organization address
address: Gran Via de les Corts Catalanes 587 contact info |
ES (Barcelona) | participant | 172˙300.00 |
| 11 |
DJORDJEVIC SPECIJALISTICKA ORDINACIJA IZ INTERNE MEDICINE PROFESOR DR PREDRAG DORDEVIC DEDINJE PREDUZETNIK
Organization address
address: ALEKSANDRA STAMBOLISKOG 10 A contact info |
RS (BEOGRAD) | participant | 172˙300.00 |
| 12 |
FONDAZIONE MARIO NEGRI SUD-CENTRO DI RICERCHE FARMACOLOGICHE EB IOMEDICHE
Organization address
address: Via Nazionale 8/A contact info |
IT (SANTA MARIA IMBARO) | participant | 172˙300.00 |
| 13 |
GEMEINNUTZIGE SALZBURGER LANDESKLINIKEN BETRIEBSGESELLSCHAFT
Organization address
city: Salzburg contact info |
AT (Salzburg) | participant | 172˙300.00 |
| 14 |
ISTANBUL UNIVERSITESI
Organization address
address: ISTANBUL UNIVERSITESI CENTER CAMPUS BEYAZIT EMINONU contact info |
TR (ISTANBUL) | participant | 172˙300.00 |
| 15 |
LIETUVOS SVEIKATOS MOKSLU UNIVERSITETAS
Organization address
address: A MICKEVICIAUS GATVE 9 contact info |
LT (KAUNAS) | participant | 172˙300.00 |
| 16 |
NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS
Organization address
address: CHRISTOU LADA 6 contact info |
EL (ATHENS) | participant | 172˙300.00 |
| 17 |
UNIVERSITE DE GENEVE
Organization address
address: Rue du General Dufour 24 contact info |
CH (GENEVE) | participant | 172˙300.00 |
| 18 |
UNIWERSYTET JAGIELLONSKI
Organization address
address: Ul. Golebia 24 contact info |
PL (KRAKOW) | participant | 172˙300.00 |
| 19 |
UNIVERSITY MULTI-PROFILE HOSPITAL FOR ACTIVE TREATMENT ALEXANDROVSKA EAD
Organization address
address: GEORGI SOFIISKI STREET 1 contact info |
BG (SOFIA) | participant | 172˙201.00 |
| 20 |
E-DIAGNOSTIC OFTALMOLOGIA SL
Organization address
address: PASEO DE BELEN CAMPUS MIGUEL DELIBES EDIFICIO I+D 11 contact info |
ES (VALLADOLID) | participant | 126˙160.00 |
| 21 |
CONSIGLIO NAZIONALE DELLE RICERCHE
Organization address
address: Piazzale Aldo Moro 7 contact info |
IT (ROMA) | participant | 95˙685.00 |
| 22 |
VASTRA GOTALANDS LANS LANDSTING
Organization address
address: REGIONENS HUS contact info |
SE (VANERSBORG) | participant | 71˙640.00 |
| 23 |
AARDEX GROUP SA
Organization address
address: AVENUE DE LA GARE 29 contact info |
CH (Sion) | participant | 62˙760.00 |
| 24 |
IMPETO MEDICAL
Organization address
address: RUE CAMPAGNE PREMIERE 17 contact info |
FR (PARIS) | participant | 62˙760.00 |
| 25 |
FUNDACIO INSTITUT DE RECERCA DE L'HOSPITAL UNIVERSITARI VALL D'HEBRON
Organization address
address: Passeig Vall d'Hebron contact info |
ES (BARCELONA) | participant | 59˙359.80 |
| 26 |
HELSINGIN YLIOPISTO
Organization address
address: YLIOPISTONKATU 4 contact info |
FI (HELSINGIN YLIOPISTO) | participant | 53˙799.40 |
| 27 |
UNIVERSITAET FUER WEITERBILDUNG KREMS
Organization address
address: DR.-KARL-DORREKSTRASSE 30 contact info |
AT (KREMS) | participant | 47˙000.00 |
| 28 |
INSTITUTO DE INVESTIGACION Y ASISTENCIA PSIQUIATRICA SL
Organization address
address: CALLE SERRANO 178 contact info |
ES (MADRID) | participant | 27˙810.00 |
| 29 |
OIVAUNI OY
Organization address
address: KAIKUKATU 43 contact info |
FI (KUOPIO) | participant | 27˙500.00 |
| 30 |
QUEEN MARY UNIVERSITY OF LONDON
Organization address
address: 327 MILE END ROAD contact info |
UK (LONDON) | participant | 25˙640.00 |
| 31 |
FEDERATION INTERNATIONALE DU DIABETE REGION EUROPE AISBL
Organization address
address: CHAUSSEE DE LA HULPE 166 BLOC C contact info |
BE (BRUXELLES) | participant | 22˙500.00 |
| 32 |
FUNDACION JIMENEZ DIAZ UTE
Organization address
address: AVENIDA REYES CATOLICOS 2 contact info |
ES (MADRID) | participant | 0.00 |
| 33 |
PARACELSUS MEDIZINISCHE PRIVATUNIVERSITAT SALZBURG
Organization address
address: STRUBERGASSE 21 contact info |
AT (SALZBURG) | participant | 0.00 |
| 34 |
THE UNIVERSITY OF SYDNEY
Organization address
address: The University of Sydney contact info |
AU (SYDNEY) | participant | 0.00 |
Mappa
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Obiettivo del progetto (Objective)
'Background: A significant proportion of pre-diabetics, show macro and micro vascular complications associated with hyperglycaemia. Although many trials have demonstrated the efficacy of lifestyle and pharmaceutical interventions in diabetes prevention, no trial has evaluated the extent to which mid- and long-term complications can be prevented by early interventions on hyperglycaemia. Aims: To assess the long-term effects on multiple complications of hyperglycaemia of early intensive management of hyperglycaemia with sitagliptin, metformin or their combination added to lifestyle intervention (LSI) (diet and physical activity), compared with LSI alone in adults with non-diabetic intermediate hyperglycaemia (IFG, IGT or both). Study Design: Long-term, multi-centre, randomised, partially double blinded, placebo controlled, phase-IIIb clinical trial with prospective blinded outcome evaluation. Participants will be randomised to four parallel arms: 1) LSI 2 placebo tablets/day; 2) LSI 2 Metformin tablets of 850 mg/day; 3) LSI 2 Sitagliptin tablets of 50 mg/day; 4) LSI 2 tablets of a fixed-dose combination of Sitagliptin 50mg and Metformin 850 /day. Active intervention will last for at least 3 years, and additional follow-up up to 5 years. Setting and population: Males and Females with pre-diabetes (IFG, IGT or both) aged 45 to 74 years selected from primary care screening programs in 15 clinical centres from 12 countries: Australia, Austria, Bulgaria, Germany, Greece, Italy, Lithuania, Poland, Serbia, Spain, Switzerland and Turkey. (N=3000) Main Outcomes: The primary endpoint is a combined continuous variable: “the microvascular complication índex' (MCI) composed by a linear combination of the Early Treatment Diabetic Retinopathy Study Scale (ETDRS) score (based on retinograms), the level of urinary albumin to creatinine ratio, and a measure of distal small fibre neuropathy (sudomotor test by SUDOSCAN), measured during baseline visit and at 36th and 60th month visits after randomisation. In addition, this project will include the evaluation of early novel serological biomarkers of systemic inflammation, early micro-vascular damage, non-alcoholic fatty liver disease, insulin sensitivity and insulin secretion, and measures of quality of life, sleep quality (somnograms) and neuropsychological evaluation. Vascular function and structure will be evaluated in a subset of participants (n=1000), including cIMT and microvascular endothelial function measured by EndoPAT. Expected results: By evaluating the effect of aggressive treatments in pre-diabetes for the early prevention of diabetes complication, this project has the potential of changing the current paradigm of early management of hyperglycaemia. The ultimate goal is the development of a standardized core protocol for the early prevention of microvascular and other complications, impacting social cost as a result not only in health care, but also in disabilities at work.'