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Completed

NCT Number: NCT03598400

HIT on Hypoglycemic Risk in Type 1 Diabetes (T1D)

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 Recent work (unpublished) from our lab suggests high intensity interval training (HIT) may reduce the risk of hypoglycaemia in people with type 1 diabetes, however stronger evidence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

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Key information

Conditions

Type1diabetes

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liverpool John Moores University

Liverpool, L33AF, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Intensity Interval Training

Behavioral

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

Behavioral

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 outcomes

  1. Severe hypoglycaemia

    Time frame: 2 weeks

    Number of severe hypoglycaemic events (<3mmol/l) during the 2 week intervention period

Secondary outcomes

  1. Mean glucose

    Time frame: 2 weeks

    mean glucose level over 2 week recording period

  2. % of time in level 2 hypoglycaemia (<3.0mmol/L)

    Time frame: 2 weeks

    % of time in level 2 hypoglycaemia (<3.0mmol/L) over 2 week recording period

  3. % of time in level 1 hypoglycaemia (3.0-3.9mmol/L)

    Time frame: 2 weeks

    % of time in level 1 hypoglycaemia (3.0-3.9mmol/L) over 2 week recording period

  4. % of time in target range (3.9-10.0mmol/L)

    Time frame: 2 weeks

    % of time in target range (3.9-10.0mmol/L) over 2 week recording period

  5. % of time in level 1 hyperglycaemia (10.0-13.9mmol/L)

    Time frame: 2 weeks

    % of time in level 1 hyperglycaemia (10.0-13.9mmol/L) over 2 week recording period

  6. % of time in level 2 hyperglycaemia (>13.9mmol/L)

    Time frame: 2 weeks

    % of time in level 2 hyperglycaemia (>13.9mmol/L) over 2 week recording period

  7. glycaemic variability (coefficient of variation and Standard Deviation)

    Time frame: 2 weeks

    glycaemic variability over 2 week recording period

  8. area under the curve of episodes of hypoglycaemia and hyperglycaemia

    Time frame: 2 weeks

    area under the curve of episodes of hypoglycaemia and hyperglycaemia 2 week recording period

Sponsors and collaborators

Lead sponsor

Liverpool John Moores University

Other

Collaborators

  • Royal Liverpool University Hospital
  • Society for Endocrinology
  • University of Birmingham
  • University of Exeter

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 26, 2018
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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