Trial gets underway aimed at preventing type 1 diabetes in at risk youngsters

by Barbara Hewitt on April 21, 2016

A clinical study evaluating a new hypothesis that an inexpensive drug with a simple treatment regime can prevent type 1 diabetes has been launched in the UK.

The autoimmune diabetes Accelerator Prevention Trial (adAPT) will look at giving metformin, the most common diabetes drug, to young people at high risk of developing type 1 diabetes to see if it can prevent the condition.

The study, led by Professor Terence Wilkin, of the University of Exeter Medical School, with support from colleagues at the University of Dundee and NHS Tayside aims to contact all 6,400 families in Scotland affected by the condition, with a view to expanding into England at a later date.

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Children aged 5 to 16 who have a sibling or parent with type 1 diabetes will be invited for a blood test to establish whether they are at high risk of developing the disease. If so, they will be invited to take part in the trial.

Researchers will then examine the impact of administering metformin to young people in the high risk category as a way of preventing diabetes and also explore why the incidence of type 1 diabetes has risen fivefold in the last 40 years.

Researchers have previously hypothesised that type 1 diabetes is an autoimmune disease caused by a faulty immune system which attacks and destroys insulin producing beta cells in the pancreas. Clinical trials have tried drugs that supress the immune system to attempt to subdue the attack, but the results have so far been disappointing.

The Accelerator Prevention Trial is the first to test an alternative explanation for type 1 diabetes, and is based on the accelerator hypothesis, proposed in 2001 by Professor Wilkin that autoimmunity occurs as a response to damaged beta cells.

He believes that beta cells, stressed by being made to work too hard in a modern environment, send out signals that switch on the immune system. The adAPT study will test whether metformin, which is known to protect the beta cells from stress, can stop the immune response that goes on to destroy them.

“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,” said Wilkin.

“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,” he explained.

It is thought that 80,000 children develop type 1 diabetes worldwide each year. There is currently no way of preventing childhood diabetes in children and no cure, meaning type 1 diabetes patients face strict dietary controls and multiple daily injections of insulin for life.

In the trial, each child will receive metformin or a placebo initially for four months, during which they will 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. 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.

“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. The adAPT trial 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,” Wilkin explained.

According to Professor Stephen Greene of the University of Dundee and the Tayside Clinical Trials Unit, it is an 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,” he said.


The opinions expressed in this article do not necessarily reflect the views of the DiabetesForum.com Community and should not be interpreted as medical advice. Please see your doctor before making any changes to your diabetes management plan.

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