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
Coordinator: Leocadio RODRÍGUEZ MAÑAS
Project Number: 278803
EC contribution: € 5,975,821.00
Project website: http://www.midfrail-study.org/
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