HIT4HYPOS

• Research type

  Research Study

• Full title

  High Intensity Training as a novel treatment for impaired awareness of hypoglycaemia in type 1 diabetes

• IRAS ID

  254601

• Contact name

  Rory McCrimmon

• Contact email

  r.mccrimmon@dundee.ac.uk

• Sponsor organisation

  University of Dundee

• Duration of Study in the UK

  1 years, 11 months, 31 days

• Research summary

  Reduced awareness of low blood glucose (hypoglycaemia) affects about 25-30% of all people with type 1 diabetes. It puts that person at a much greater risk of severe hypoglycaemia (loss of consciousness or coma) and it remains one of the major concerns of people with type 1 diabetes. We currently have no treatments for this condition other than structured education and sometimes when extremely problematic, pancreas transplantation. This trial is based on the idea that repeated mild to moderate episodes of low glucose build up a memory in the brain which then learns to adapt to it. The brain has to adapt because each time it experiences low glucose the cells in the body become stressed and this is damaging in the long-term. This type of memory is called ‘habituation’. This concept raises the possibility that by introducing a new stress,‘dishabituation’, we might be able to restore hypoglycaemia awareness. We are going to use short bursts of high intensity exercise (HIT) as a dishabituating stimulus to see if this can be used as a treatment for reduced awareness of hypoglycaemia.
  This is a randomised parallel group pilot study involving participants with type 1 diabetes who have impaired awareness of hypoglycaemia. Participants will be randomised to 4 weeks of continuous glucose monitoring (CGM) or CGM and HIT. There will be a 4 week run-in period to optimise diabetes control. Following this all participants will undergo a baseline hypoglycaemic clamp study where we will reduce their blood glucose level in a controlled manner and monitor their response in the form of blood tests and questionnaires. There will then be 4 weeks of CGM +/- high intensity exercise (intervention period). At the end of the 4 weeks they will again undergo a hypoglycaemic clamp study. There will be 8 study visits.

• REC name

  South East Scotland REC 02

• REC reference

  18/SS/0160

• Date of REC Opinion

  17 Dec 2018

• REC opinion

  Favourable Opinion