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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

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

Coordinator

SERVICIO MADRILENO DE SALUD

Address

Plaza Carlos Trias Bertran 7
28020 Madrid

Spain

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 1 347 893,88

Administrative Contact

Belen Riquelme Garcia (Ms.)

Participants (16)

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UNIVERSITY OF BEDFORDSHIRE

United Kingdom

EU Contribution

€ 291 626,18

CARDIFF UNIVERSITY

United Kingdom

EU Contribution

€ 269 629,12

IGEN BIOTECH SL

Spain

EU Contribution

€ 331 200

CHU HOPITAUX DE BORDEAUX

France

EU Contribution

€ 344 385,20

HEXABIO SARL

France

EU Contribution

€ 162 400

UNIVERSITA DEGLI STUDI DELLA CAMPANIA LUIGI VANVITELLI

Italy

EU Contribution

€ 336 400

CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE

France

EU Contribution

€ 308 125

UNIVERSITAET ULM

Germany

EU Contribution

€ 277 440

UNIVERSITEIT GENT

Belgium

EU Contribution

€ 327 600

UNIVERSIDAD DE CASTILLA - LA MANCHA

Spain

EU Contribution

€ 216 800

UNIVERZITA KARLOVA

Czechia

EU Contribution

€ 149 840

CONSORCIO DE APOYO A LA INVESTIGACION BIOMEDICA EN RED

Spain

EU Contribution

€ 14 685,50

NICHE SCIENCE & TECHNOLOGY LTD

United Kingdom

EU Contribution

€ 647 542,30

UNIVERSITA CATTOLICA DEL SACRO CUORE

Italy

EU Contribution

€ 225 600

VRIJE UNIVERSITEIT BRUSSEL

Belgium

EU Contribution

€ 204 480

DIABETES FRAIL LIMITED

United Kingdom

EU Contribution

€ 520 173,82

Project information

Grant agreement ID: 278803

Status

Closed project

  • Start date

    1 March 2012

  • End date

    30 April 2017

Funded under:

FP7-HEALTH

  • Overall budget:

    € 7 533 728,97

  • EU contribution

    € 5 975 821

Coordinated by:

SERVICIO MADRILENO DE SALUD

Spain