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A RANDOMIZED CLINICAL TRIAL TO EVALUATE THE EFFECTIVENESS OF A MULTI-MODAL INTERVENTION IN OLDER PEOPLE WITH TYPE 2 DIABETES ON FRAILTY AND QUALITY OF LIFE: THE MID-FRAIL STUDY

Objetivo

The prevalence of diabetes in people ≥ 65 years approaches 25% (40% of all patients with diabetes are > 65 years). This number will increase 4-fold in people > 70 years in 2050. Diabetes results in a high personal and social health burden, and a significant public health burden in terms of rising healthcare costs. Diabetes is associated with increased functional decline in older people and may explain up to 20% of their excess risk of disability. Our project focuses on the use of interventions to improve functional status and enhance quality of life. This is justified because there has been a lack of intervention studies in this population and improvements in function and well-being may be of more clinical benefit in older patients than attention to metabolic control alone.
The MID-FRAIL STUDY is a Phase IIb open randomized clinical trial to evaluate the effectiveness of a multi-modal intervention (optimizing medical management, resistance-based exercise program and educational/nutritional intervention) in 1,704 frail or pre-frail subjects ≥ 70 years with T2D to prevent functional decline and maintain or improve quality of life and its associated costs.
This approach is original (both the intervention and outcomes are unique for studies in diabetes), relevant (it concerns 25% of people with diabetes), pertinent and feasible.
The project is highly aligned with objectives pursued by two topics of this call: investigator-driven clinical trials in elderly populations (HEALTH 2011 2.2.2-1) and in diabetes complications (HEALTH.2011.2.4.3-1).
The study aims to demonstrate a reduction of 20% in that risk, which will mean an annual prevention of around 700,000 incident cases of some disability in old people, with a major impact on global quality of life and financial costs. This is especially true in older women. Three research-intensive SMEs will play a leading role in this project and it also has the support of Diabetes UK, a major patient and family advocacy organisation

Convocatoria de propuestas

FP7-HEALTH-2011-two-stage
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Coordinador

SERVICIO MADRILENO DE SALUD
Dirección
Plaza Carlos Trias Bertran 7
28020 Madrid
España
Tipo de actividad
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Aportación de la UE
€ 1 347 893,88
Contacto administrativo
Belen Riquelme Garcia (Ms.)

Participantes (16)

UNIVERSITY OF BEDFORDSHIRE

La participación finalizó

United Kingdom
Aportación de la UE
€ 291 626,18
Dirección
University Square
LU1 3JU Luton
Tipo de actividad
Higher or Secondary Education Establishments
Contacto administrativo
Arif Urfan (Mr.)
CARDIFF UNIVERSITY
United Kingdom
Aportación de la UE
€ 269 629,12
Dirección
Newport Road 30-36
CF24 ODE Cardiff
Tipo de actividad
Higher or Secondary Education Establishments
Contacto administrativo
Nick Bodycombe (Mr.)
IGEN BIOTECH SL
España
Aportación de la UE
€ 331 200
Dirección
Calle Gustavo Fernandez Balvuena 11
28002 Madrid
Tipo de actividad
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Contacto administrativo
David Segarra (Mr.)
CHU HOPITAUX DE BORDEAUX
Francia
Aportación de la UE
€ 344 385,20
Dirección
Rue Dubernat 12
33404 Talence
Tipo de actividad
Higher or Secondary Education Establishments
Contacto administrativo
Jean-Jacques Jalibert (Mr.)
HEXABIO SARL
Francia
Aportación de la UE
€ 162 400
Dirección
Avenue Pasteur 286
33600 Pessac
Tipo de actividad
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Contacto administrativo
Joël Poustis (Mr.)
UNIVERSITA DEGLI STUDI DELLA CAMPANIA LUIGI VANVITELLI
Italia
Aportación de la UE
€ 336 400
Dirección
Viale Abramo Lincoln 5
81100 Caserta
Tipo de actividad
Higher or Secondary Education Establishments
Contacto administrativo
Biagio Carella (Dr.)
CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE
Francia
Aportación de la UE
€ 308 125
Dirección
Rue Viguerie 2 Hotel Dieu Saint Jacques
31052 Toulouse Cedex 3
Tipo de actividad
Higher or Secondary Education Establishments
Contacto administrativo
Odile Sechoy-Balussou (Dr.)
UNIVERSITAET ULM
Alemania
Aportación de la UE
€ 277 440
Dirección
Helmholtzstrasse 16
89081 Ulm
Tipo de actividad
Higher or Secondary Education Establishments
Contacto administrativo
Frank Gleixner (Mr.)
UNIVERSITEIT GENT
Bélgica
Aportación de la UE
€ 327 600
Dirección
Sint Pietersnieuwstraat 25
9000 Gent
Tipo de actividad
Higher or Secondary Education Establishments
Contacto administrativo
Margo Baele (Dr.)
UNIVERSIDAD DE CASTILLA - LA MANCHA
España
Aportación de la UE
€ 216 800
Dirección
Calle Altagracia 50
13071 Ciudad Real
Tipo de actividad
Higher or Secondary Education Establishments
Contacto administrativo
Maria Llanos Carrión Varela (Ms.)
UNIVERZITA KARLOVA
Chequia
Aportación de la UE
€ 149 840
Dirección
Ovocny Trh 560/5
11636 Praha 1
Tipo de actividad
Higher or Secondary Education Establishments
Contacto administrativo
Kristyna Matejkova (Ms.)
CONSORCIO DE APOYO A LA INVESTIGACION BIOMEDICA EN RED

La participación finalizó

España
Aportación de la UE
€ 14 685,50
Dirección
Calle Sinesio Delgado 6
28029 Madrid
Tipo de actividad
Research Organisations
Contacto administrativo
Almudena Moreno (Ms.)
NICHE SCIENCE & TECHNOLOGY LTD
United Kingdom
Aportación de la UE
€ 647 542,30
Dirección
Wolsey Drive 96
KT2 5DW Kingston Upon Thames
Tipo de actividad
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Contacto administrativo
Timothy Hardman (Dr.)
UNIVERSITA CATTOLICA DEL SACRO CUORE
Italia
Aportación de la UE
€ 225 600
Dirección
Largo Agostino Gemelli 1
20123 Milano
Tipo de actividad
Higher or Secondary Education Establishments
Contacto administrativo
Filippo Leone (Mr.)
VRIJE UNIVERSITEIT BRUSSEL
Bélgica
Aportación de la UE
€ 204 480
Dirección
Pleinlaan 2
1050 Brussel
Tipo de actividad
Higher or Secondary Education Establishments
Contacto administrativo
Maria Vereeken (Ms.)
DIABETES FRAIL LIMITED
United Kingdom
Aportación de la UE
€ 520 173,82
Dirección
Oakmoore Court 11 C Kingswood Road Hapmton Lovett
WR9 0QH Droitwitch
Tipo de actividad
Research Organisations
Contacto administrativo
Alan Sinclair (Prof.)