Major type 1 prevention trial to start

An “extremely important” trial looking at a possible way to prevent type 1 diabetes is set to start in Scotland, it has been announced.

Researchers from the University of Exeter Medical School will contact all 6,400 families in the country who are affected by the condition.

A blood test will be administered to children who have a parent or sibling with the condition to see if they are at high risk of developing it.

Those that are, will be invited to take part in the study which will examine the impact of administering metformin, which is currently the world’s most commonly prescribed diabetes medicines.

Immune system

Professor Terence Wilkin, who is leading the autoimmune diabetes Accelerator Prevention Trial (adAPT) study, said: “We still have no means of preventing type 1 diabetes, which, at all ages, results from insufficient insulin. We all lose beta cells over the course of our lives, but most of us have enough for normal function.

“However, if the rate of beta cell loss is accelerated, type 1 diabetes develops, and the faster the loss, the younger the onset of the condition. The accelerator hypothesis talks of fast and slow type 1 diabetes – beta cell loss which progresses at different rates in different people, and appears at different ages as a result.”

The Accelerator Prevention Trial is the first to test an alternative explanation for type 1 diabetes.

Each participating child will either receive metformin or a placebo initially for four months. They will then be tested three times to assess how their metabolism and immune system respond.

The first stage of the trial will assess safety and whether the trial design works, whether the medication can reduce beta cell stress, and how many participants will be needed to progress the study.

A simple, safe and effective drug that would prevent the development of type 1 diabetes in young people would be a major breakthrough

If the trial medication is found to lower beta cell stress effectively, the children in stage 1 will progress into the next stages of the trial.

‘Cost-effective’

Professor Wilkin said: “It is possible that a modern environment accelerates the loss of beta cells by overworking and stressing them.

“As a consequence, this could be contributing to the rising incidence of type 1 diabetes, which is appearing in ever younger age groups.

“adAPT will use a medication to protect the beta cells from the stress, so that they survive longer. If successful, the trial will offer a means of preventing type 1 diabetes with a cost-effective medication, and could be made immediately available to children at risk.”

Professor Wilkin is carrying out the research in collaboration with Professor Stephen Greene of the University of Dundee and the Tayside Clinical Trials Unit.

The trial is launching in Scotland because the country has the third highest rate of type 1 diabetes in the world as well as a highly efficient record linkage system to identify affected families and a cohesive group of paediatric diabetologists.

Tayside is the first centre to start recruitment for adAPT, but the study will roll out to the other 10 health boards in Scotland before crossing into England.

Dr Vicky Alexander, clinical lead children’s diabetes service NHS Tayside said: “We are delighted to be supporting this exciting study looking at the prevention of Type1 diabetes in children.”

Professor Greene, who is also director of the Scottish Children’s Research Network, said: “adAPT is an extremely important clinical trial and it is appropriate that ScotCRN, with the Universities of Dundee and Exeter and NHS Scotland are driving forward this exciting project. A simple, safe and effective drug that would prevent the development of type 1 diabetes in young people would be a major breakthrough.”