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
Sponsor organisation
University of Dundee
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Summary of Research
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.Summary of Results
This was a randomised parallel group study of people living with type 1 diabetes and impaired awareness of hypoglycaemia (IAH). People who live with type 1 diabetes and have IAH do not recognise or develop symptoms of low blood sugar (hypoglycaemia) until their blood glucose levels fall very low which can be dangerous as leads to increased risk of coma, seizure and death.All participants (n=18) used continuous glucose monitoring during the 4 week study intervention period, in add we introduced 4 weeks of high intensity interval training (HIIT) on a static exercise bike 3 times a week as an intervention for half of the study participants (n=9). At baseline and on completion of the 4 week intervention period all participants underwent hyperinsulinaemic hypoglycaemic clamp studies. This is an experimental method used to induce hypoglycaemia (low blood sugar) in a safe and controlled manner so that physiological and biochemical changes can be monitored and assessed. The aim of the study was to assess whether participants would have an improved counter regulatory symptom and hormonal response to low blood sugar (hypoglycaemia) following 4 weeks of HIIT compared to the participants who did not take part in HIIT.
The results showed a hightened hormonal response to hypoglycaemia following HIIT with a significant increase in glucagon response to hypoglycaemia when adjusted to baseline results and an increase in the adrenaline response to hypoglycaemia also. In addition, there was a significant reduction in symptoms of hypoglycaemia in those participants who did not carry out HIIT. These results suggest that HIIT may at least temporarily improve the hormonal and sustain the symptom response to hypoglycaemia in people who live with type 1 diabetes and impaired awareness of hypoglycaemia.
REC name
South East Scotland REC 02
REC reference
18/SS/0160
Date of REC Opinion
17 Dec 2018
REC opinion
Favourable Opinion