Dishabituation as Rx for IAH in T1D
Research type
Research Study
Full title
Dishabituation as a treatment for impaired awareness of hypoglycaemia in type 1 diabetes.
IRAS ID
236766
Contact name
Rory McCrimmon
Contact email
Sponsor organisation
University of Dundee/NHS Tayside
ISRCTN Number
ISRCTN15236211
Duration of Study in the UK
2 years, 0 months, 0 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 with 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 pancreas transplantation when problems become extreme. This trial is based on the new idea that repeated mild to moderate episodes of low glucose build up a memory in your brain which then learns to adapts to it. The brain has to adapt because each time it experiences low glucose the cells in the body become very stressed and this is damaging in the long-term. This type of memory is called ‘habituation’ and this raises the possibility that by introducing a new stress,‘Dishabituation’, we might be able to restore hypoglycaemia awareness. We are going to be using short bursts of high intensity exercise as a dishabituating stimulus to see if this will improve a person's awareness of low blood glucose.
This is a randomised crossover study involving participants with type 1 diabetes who have an impaired awareness of hypoglycaemia. Participants will be randomised to start with a period of rest or a high intensity exercise program on an exercise bike. The following day they will undergo a hypoglycaemic clamp study where we will reduce their blood glucose level in a controlled manner and monitor their response to it in the form of blood tests and questionnaires. Participants will cross over two weeks later to undergo the opposite intervention and again undergo a hypoglycaemic clamp study. There will be 5-7 visits to the Clinical Research Centre, the study will last approximately 6 weeks in total.Summary of Results
This was a proof of concept study based upon the hypothesis that impaired awareness of hypoglycaemia (IAH) in type 1 diabetes develops as a form of learned behaviour called habituation. We introduced high intensity exercise (HIT) as a novel stressor to act as a dishabituating stimulus. The aim of this study was to examine whether the introduction of a novel stimulus in the form of high intensity exercise will lead to at least partial recovery of counterregulatory responses to hypoglycaemia induced the following day in adults with type 1 diabetes and impaired awareness of hypoglycaemia.This was a randomised cross over study comparing HIT with rest as a control. The primary end point was change in adrenaline in response to hypoglycaemia following each intervention. The secondary outcomes were change in other counter regulatory hormones, symptom awareness, mood and cognition.
We successfully recruited 12 participants to the study, there were no adverse events and all participant completed both arms of the study.
We have found that dishabituation with high intensity exercise restores at least temporarily the counter regulatory response to hypoglycaemia with a significant rise in adrenaline after HIT during hypoglycaemia the following day. In addition, participants were more symptomatic of hypoglycaemia following HIT and there was prolongation of the four choice reaction time test in keeping with the normal physiological cognitive response to hypoglycaemia.
REC name
South East Scotland REC 02
REC reference
17/SS/0150
Date of REC Opinion
1 Dec 2017
REC opinion
Further Information Favourable Opinion