Using METformin to PREVENT progression to frailty for older people (MET-PREVENT) – a randomised controlled proof-of-concept trial

Principal Investigator: Professor Miles Witham

Synopsis

The aim of the MET-PREVENT study is to determine whether the drug metformin, commonly used to treat diabetes, can improve physical function in older people living with frailty.

Frailty affects over 1.8 million people aged over 60 in England and is associated with an increased risk of poor health outcomes, including falls and fractures, higher rates of hospital admission, prolonged hospital stays, a greater need for social care, and in some cases, premature death.

Prefrailty is the state which precedes frailty. This may be a good point at which to offer potential treatments because interventions at this stage may prevent progression to frailty. In addition, people with prefrailty may tolerate treatments better than those living with advanced frailty.

At present, exercise is the best known option to prevent progression from prefrailty to frailty, but not everyone can, or would like to exercise. It is therefore important to find alternatives to alleviate the huge health and care burden that comes with frailty.

The ground-breaking MET-PREVENT trial is one of the first trials to test whether medications can prevent this progression to frailty for older people.

The study

This study will recruit 80 people aged 65 and over via clinics at Newcastle Hospitals, via GP practices, and through already-established patient cohorts. Half of the participants will take 500mg of metformin three times a day for four months, while the other will take a placebo. The team will assess the difference between the two groups in the 4 metre walk speed, after four months as a primary outcome, but will also assess a number of other outcomes linked to muscle strength and mass, grip strength and quality of life.

The study will also test trial processes, recruitment and retention for this group of participants, which will support larger studies involving people over 65 living with prefrailty; a group currently underrepresented in clinical trials.

A series of samples will be taken for future research which will uncover more about the mechanisms by which metformin improves muscle function and frailty. This will give important insights into the fundamental biology of ageing, helping to identify new treatments for testing in future clinical trials.