Skip to main content

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

Objective

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

Field of science

  • /medical and health sciences/health sciences/public and environmental health
  • /medical and health sciences/clinical medicine/endocrinology/diabetes

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

SERVICIO MADRILENO DE SALUD
Address
Plaza Carlos Trias Bertran 7
28020 Madrid
Spain
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
EU contribution
€ 1 347 893,88
Administrative Contact
Belen Riquelme Garcia (Ms.)

Participants (16)

UNIVERSITY OF BEDFORDSHIRE

Participation ended

United Kingdom
EU contribution
€ 291 626,18
Address
University Square
LU1 3JU Luton
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Arif Urfan (Mr.)
CARDIFF UNIVERSITY
United Kingdom
EU contribution
€ 269 629,12
Address
Newport Road 30-36
CF24 ODE Cardiff
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Nick Bodycombe (Mr.)
IGEN BIOTECH SL
Spain
EU contribution
€ 331 200
Address
Calle Gustavo Fernandez Balvuena 11
28002 Madrid
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
David Segarra (Mr.)
CHU HOPITAUX DE BORDEAUX
France
EU contribution
€ 344 385,20
Address
Rue Dubernat 12
33404 Talence
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Jean-Jacques Jalibert (Mr.)
HEXABIO SARL
France
EU contribution
€ 162 400
Address
Avenue Pasteur 286
33600 Pessac
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Joël Poustis (Mr.)
UNIVERSITA DEGLI STUDI DELLA CAMPANIA LUIGI VANVITELLI
Italy
EU contribution
€ 336 400
Address
Viale Abramo Lincoln 5
81100 Caserta
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Biagio Carella (Dr.)
CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE
France
EU contribution
€ 308 125
Address
Rue Viguerie 2 Hotel Dieu Saint Jacques
31052 Toulouse Cedex 3
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Odile Sechoy-Balussou (Dr.)
UNIVERSITAET ULM
Germany
EU contribution
€ 277 440
Address
Helmholtzstrasse 16
89081 Ulm
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Frank Gleixner (Mr.)
UNIVERSITEIT GENT
Belgium
EU contribution
€ 327 600
Address
Sint Pietersnieuwstraat 25
9000 Gent
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Margo Baele (Dr.)
UNIVERSIDAD DE CASTILLA - LA MANCHA
Spain
EU contribution
€ 216 800
Address
Calle Altagracia 50
13071 Ciudad Real
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Maria Llanos Carrión Varela (Ms.)
UNIVERZITA KARLOVA
Czechia
EU contribution
€ 149 840
Address
Ovocny Trh 560/5
116 36 Praha 1
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Kristyna Matejkova (Ms.)
CONSORCIO DE APOYO A LA INVESTIGACION BIOMEDICA EN RED

Participation ended

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