HIT on Hypoglycemic Risk in Type 1 Diabetes (T1D)

Type1diabetes Clinical Trial

Official title:

Can High Intensity Interval Training Reduce Fear of Hypoglycaemia and Improve Glycaemic Control in People With Type 1 Diabetes?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03598400
• Other study ID #: T1D1
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: February 2020
• Source: Liverpool John Moores University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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 Recent work (unpublished) from our lab suggests high intensity interval training (HIT) may reduce the risk of hypoglycaemia in people with type 1 diabetes, however stronger evidence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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

Behavioral:
• high intensity interval training
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.
• moderate intensity continous training
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.

Locations

Country	Name	City	State
United Kingdom	Liverpool John Moores University	Liverpool

Sponsors (5)

Lead Sponsor	Collaborator
Liverpool John Moores University	Royal Liverpool University Hospital, Society for Endocrinology, University of Birmingham, University of Exeter

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe hypoglycaemia	Number of severe hypoglycaemic events (<3mmol/l) during the 2 week intervention period	2 weeks
Secondary	Mean glucose	mean glucose level over 2 week recording period	2 weeks
Secondary	% of time in level 2 hypoglycaemia (<3.0mmol/L)	% of time in level 2 hypoglycaemia (<3.0mmol/L) over 2 week recording period	2 weeks
Secondary	% 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	2 weeks
Secondary	% 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	2 weeks
Secondary	% 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	2 weeks
Secondary	% of time in level 2 hyperglycaemia (>13.9mmol/L)	% of time in level 2 hyperglycaemia (>13.9mmol/L) over 2 week recording period	2 weeks
Secondary	glycaemic variability (coefficient of variation and Standard Deviation)	glycaemic variability over 2 week recording period	2 weeks
Secondary	area under the curve of episodes of hypoglycaemia and hyperglycaemia	area under the curve of episodes of hypoglycaemia and hyperglycaemia 2 week recording period	2 weeks