HIT on Hypoglycemic Risk in Type 1 Diabetes (T1D)

Not Applicable

Completed

• Conditions: Type1diabetes
• Interventions: Behavioral: high intensity interval training; Behavioral: moderate intensity continous training

• Registration Number: NCT03598400
• Lead Sponsor: Liverpool John Moores University

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 Recent work (unpublished) from our lab suggests high intensity interval training (HIT) may reduce the risk of hypoglycaemia in people with type 1 diabetes, however stronger evidence is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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-07-24
• Study First Posted: 2018-07-26
• Study Start: 2018-08-01
• Status Verified: 2020-02
• Primary Completion: 2020-08-01
• Study Completion: 2020-08-01
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
high intensity interval training	high intensity interval training	Participants will complete high intensity interval training during a 2 week intervention period
Moderate intensity continous training	moderate intensity continous training	Participants will complete moderate intensity continous training during a 2 week intervention period

Primary Outcome Measures

Name	Time	Method
Severe hypoglycaemia	2 weeks	Number of severe hypoglycaemic events (\<3mmol/l) during the 2 week intervention period

Secondary Outcome Measures

Name	Time	Method
% of time in level 2 hypoglycaemia (<3.0mmol/L)	2 weeks	% of time in level 2 hypoglycaemia (\<3.0mmol/L) over 2 week recording period
% of time in level 2 hyperglycaemia (>13.9mmol/L)	2 weeks	% of time in level 2 hyperglycaemia (\>13.9mmol/L) over 2 week recording period
Mean glucose	2 weeks	mean glucose level over 2 week recording period
% of time in level 1 hypoglycaemia (3.0-3.9mmol/L)	2 weeks	% 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)	2 weeks	% 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)	2 weeks	% of time in level 1 hyperglycaemia (10.0-13.9mmol/L) over 2 week recording period
glycaemic variability (coefficient of variation and Standard Deviation)	2 weeks	glycaemic variability over 2 week recording period
area under the curve of episodes of hypoglycaemia and hyperglycaemia	2 weeks	area under the curve of episodes of hypoglycaemia and hyperglycaemia 2 week recording period

Trial Locations

Locations (1)

Liverpool John Moores University; 🇬🇧 Liverpool, United Kingdom