HIT on Hypoglycemic Risk in Type 1 Diabetes (T1D)
Primary Purpose
Type1diabetes
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
high intensity interval training
moderate intensity continous training
Sponsored by
About this trial
This is an interventional supportive care trial for Type1diabetes
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
Sites / Locations
- Liverpool John Moores University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Experimental
Arm Label
Control
Moderate intensity continous training
high intensity interval training
Arm Description
Participants will continue with their habitual lifestyle but perform no exercise for 2 weeks
Participants will complete moderate intensity continous training during a 2 week intervention period
Participants will complete high intensity interval training during a 2 week intervention period
Outcomes
Primary Outcome Measures
Severe hypoglycaemia
Number of severe hypoglycaemic events (<3mmol/l) during the 2 week intervention period
Secondary Outcome Measures
Mean glucose
mean glucose level over 2 week recording period
% of time in level 2 hypoglycaemia (<3.0mmol/L)
% of time in level 2 hypoglycaemia (<3.0mmol/L) over 2 week recording period
% of time in level 1 hypoglycaemia (3.0-3.9mmol/L)
% of time in level 1 hypoglycaemia (3.0-3.9mmol/L) over 2 week recording period
% of time in target range (3.9-10.0mmol/L)
% of time in target range (3.9-10.0mmol/L) over 2 week recording period
% of time in level 1 hyperglycaemia (10.0-13.9mmol/L)
% of time in level 1 hyperglycaemia (10.0-13.9mmol/L) over 2 week recording period
% of time in level 2 hyperglycaemia (>13.9mmol/L)
% of time in level 2 hyperglycaemia (>13.9mmol/L) over 2 week recording period
glycaemic variability (coefficient of variation and Standard Deviation)
glycaemic variability over 2 week recording period
area under the curve of episodes of hypoglycaemia and hyperglycaemia
area under the curve of episodes of hypoglycaemia and hyperglycaemia 2 week recording period
Full Information
NCT ID
NCT03598400
First Posted
July 16, 2018
Last Updated
February 22, 2021
Sponsor
Liverpool John Moores University
Collaborators
Society for Endocrinology, Royal Liverpool University Hospital, University of Birmingham, University of Exeter
1. Study Identification
Unique Protocol Identification Number
NCT03598400
Brief Title
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
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool John Moores University
Collaborators
Society for Endocrinology, Royal Liverpool University Hospital, University of Birmingham, University of Exeter
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will continue with their habitual lifestyle but perform no exercise for 2 weeks
Arm Title
Moderate intensity continous training
Arm Type
Active Comparator
Arm Description
Participants will complete moderate intensity continous training during a 2 week intervention period
Arm Title
high intensity interval training
Arm Type
Experimental
Arm Description
Participants will complete high intensity interval training during a 2 week intervention period
Intervention Type
Behavioral
Intervention Name(s)
high intensity interval training
Intervention Description
Participants will complete 6 sessions of high intensity interval training during a 2 week intervention period. The programme involves repeated 1 minute bouts of simple on the spot movements interspersed with 1 minute of rest.
Intervention Type
Behavioral
Intervention Name(s)
moderate intensity continous training
Intervention Description
Participants will complete 6 sessions of moderate intensity continous training during a 2 week intervention period. Participants will be asked to complete 30 minutes of continuous exercise.
Primary Outcome Measure Information:
Title
Severe hypoglycaemia
Description
Number of severe hypoglycaemic events (<3mmol/l) during the 2 week intervention period
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Mean glucose
Description
mean glucose level over 2 week recording period
Time Frame
2 weeks
Title
% of time in level 2 hypoglycaemia (<3.0mmol/L)
Description
% of time in level 2 hypoglycaemia (<3.0mmol/L) over 2 week recording period
Time Frame
2 weeks
Title
% of time in level 1 hypoglycaemia (3.0-3.9mmol/L)
Description
% of time in level 1 hypoglycaemia (3.0-3.9mmol/L) over 2 week recording period
Time Frame
2 weeks
Title
% of time in target range (3.9-10.0mmol/L)
Description
% of time in target range (3.9-10.0mmol/L) over 2 week recording period
Time Frame
2 weeks
Title
% of time in level 1 hyperglycaemia (10.0-13.9mmol/L)
Description
% of time in level 1 hyperglycaemia (10.0-13.9mmol/L) over 2 week recording period
Time Frame
2 weeks
Title
% of time in level 2 hyperglycaemia (>13.9mmol/L)
Description
% of time in level 2 hyperglycaemia (>13.9mmol/L) over 2 week recording period
Time Frame
2 weeks
Title
glycaemic variability (coefficient of variation and Standard Deviation)
Description
glycaemic variability over 2 week recording period
Time Frame
2 weeks
Title
area under the curve of episodes of hypoglycaemia and hyperglycaemia
Description
area under the curve of episodes of hypoglycaemia and hyperglycaemia 2 week recording period
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Liverpool John Moores University
City
Liverpool
ZIP/Postal Code
L33AF
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared outside the research team. Anonymised group data will be presented in research articles and presentations
Learn more about this trial
HIT on Hypoglycemic Risk in Type 1 Diabetes (T1D)
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