Clinical trial NCT03598400: HIT on Hypoglycemic Risk in Type 1 Diabetes (T1D)
Official title: Can High Intensity Interval Training Reduce Fear of Hypoglycaemia and Improve Glycaemic Control in People With Type 1 Diabetes?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
Collaborators: name: Society for Endocrinology
name: Royal Liverpool University Hospital
name: University of Birmingham
name: University of Exeter
First posted: 2018-07-26
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: There is clear evidence that regular exercise improves wellbeing and reduces the risk of diabetes related complications in people with type 1 diabetes. However, many people with type 1 diabetes do not exercise regularly. The primary reason for this is fear of hypoglycaemia and loss of glycaemic control associated with exercise. This loss of glycaemic control is associated with traditional moderate intensity continous aerobic exercise advocated in the guidelines for exercise in people with type 1 diabetes. Recent work (unpublished) from our lab suggests high intensity interval training (HIT) may reduce the risk of hypoglycaemia in people with type 1 diabetes, however stronger evidence is needed before firm conclusions can be drawn.

Therefore, the aim of this study is to determine the effects of HIT on glycaemic control in people with type 1 diabetes compared to no exercise and traditional moderate intensity continous exercise.

24 people with type 1 diabetes will be recruited to complete a randomised counterbalanced cross over study comparing 3x 2-week interventions periods. During these intervention periods participant will maintain their habitual lifestyle but complete either no exercise (control), traditional moderate intensity continous exercise or high intensity interval training. Throughout the intervention periods participants glycaemic control will be monitored using a flash glucose monitor.


Eligibility criteria: Inclusion Criteria:

* T1D diagnosis more than 6 months ago (to ensure participants are out of the honeymoon period),
* Using a basal bolus insulin regime or insulin pump therapy
* BMI ≤ 32 kg.m-2

Exclusion Criteria:

* Pregnancy (or planning pregnancy)
* Disability preventing participation in an exercise regime
* Angina
* Autonomic neuropathy
* Medication that affects heart rate (this will affect estimation of fitness)
* Major surgery planned within 6 weeks of study
* Uncontrolled blood pressure
* Significant history of hyperglycaemia
* History of severe hypoglycaemia requiring third party assistance within the last 3 months
* Severe non-proliferative and unstable proliferative retinopathy

Primary outcomes:
measure: Severe hypoglycaemia
timeFrame: 2 weeks
Secondary outcomes:
measure: Mean glucose
timeFrame: 2 weeks
measure: % of time in level 2 hypoglycaemia (<3.0mmol/L)
timeFrame: 2 weeks
measure: % of time in level 1 hypoglycaemia (3.0-3.9mmol/L)
timeFrame: 2 weeks
measure: % of time in target range (3.9-10.0mmol/L)
timeFrame: 2 weeks
measure: % of time in level 1 hyperglycaemia (10.0-13.9mmol/L)
timeFrame: 2 weeks
measure: % of time in level 2 hyperglycaemia (>13.9mmol/L)
timeFrame: 2 weeks
measure: glycaemic variability (coefficient of variation and Standard Deviation)
timeFrame: 2 weeks
measure: area under the curve of episodes of hypoglycaemia and hyperglycaemia
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool John Moores University
Study officials:
References: