Details of Project
A randomised control trial taking place in 7 EU countries. It consists of a multimodal exercise and nutritional intervention in pre-frail and frail patients with Diabetes. Diabetes Frail is the lead organisation for this in the UK, which is taking place in hospitals and GP practices nationwide.
Seven countries across Europe will participate in this 4-year study, the project is co-ordinated by Professor Leocadio Rodríguez-Mañas (Hospital Universitario de Getafe, Madrid, Spain) and by Professor Alan Sinclair, Diabetes Frail, UK.
Supported by the European Union with funding of €6 million, the MID-Frail Study will run for four years and will investigate how a combined nutritional, exercise and educational intervention programme might improve the health and well-being of people over the age of 70 years with type 2 diabetes and who are becoming frail.
The MID-Frail study is an open, randomised, multicentre study, with random allocation by clusters (each trial site) to a usual care group or an intervention group. A total of 1,718 subjects will be randomised with each site enrolling on average 14 or 15 subjects. Difference in function after 2 years will be measured by changes in a summary ordinal score on the short physical performance battery (SPPB) of at least one point. Secondary outcomes include daily activities, economic evaluation, and quality of life.
The intervention group will take part in a supervised training programme with resistance exercises, alongside a nutritional and educational programme. Outcomes will be assessed against the usual care group, receiving routine diabetes care.
Aim of the Study
The primary aim is to evaluate, in comparison with usual clinical practice, the effectiveness of a multi-modal intervention (education, diet and exercise) in frail and pre-frail subjects aged equal or older than 70 years with T2D with respect to change in function and quality of life 24 months after they are randomized.
MID-Frail study recruitment closes
The recruitment for the MID-Frail study has now closed with a total of 12 sites in the UK having signed up.
The study will examine the benefits of a nutritional, exercise and educational intervention programme on the health of people over the age of 70 with Type 2 diabetes and are also becoming frail.
The EU-funded research is an open, randomised, multicentre study, which will run for four years in seven countries.
The project is being co-ordinated by Professor Leocadio Rodríguez-Mañas from the Hospital Universitario de Getafe in Madrid and Diabetes Frail’s Professor Alan Sinclair.
Professor Sinclair said: “We have been delighted with the uptake of sites. The research we plan to carry out will be extremely important as people with diabetes are vulnerable to chest and urine infections and are often frail.
“When their health deteriorates it means there are high rates of admission to hospital, which is why it’s so important to monitor their healthcare, making sure they’re receiving the right level of care.
“The more we know about how the condition affects older people, the more we can identify and review examples of best clinical practice relating to diabetes care of older people.”
A total of 127 patients have been recruited across all of the sites. They will take part in a supervised training programme with resistance exercises, alongside a nutritional and educational programme.
Outcomes will be measured after two years by changes in a summary ordinal score on the short physical performance battery (SPPB) of at least one point.
Secondary outcomes include daily activities, economic evaluation, and quality of life.
The aim of the study is to evaluate, in comparison with usual clinical practice, the effectiveness of education, diet and exercise in the patients involved and looking at change in function and quality of life 24 months after they been through the trial.