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HIT on Hypoglycemic Risk in Type 1 Diabetes (T1D)

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ClinicalTrials.gov Identifier: NCT03598400
Recruitment Status : Not yet recruiting
First Posted : July 25, 2018
Last Update Posted : August 8, 2018
Sponsor:
Collaborators:
Society for Endocrinology
Royal Liverpool University Hospital
University of Birmingham
University of Exeter
Information provided by (Responsible Party):
Liverpool John Moores University

Tracking Information
First Submitted Date  ICMJE July 16, 2018
First Posted Date  ICMJE July 25, 2018
Last Update Posted Date August 8, 2018
Estimated Study Start Date  ICMJE August 1, 2018
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
Severe hypoglycaemia [ Time Frame: 2 weeks ]
Number of severe hypoglycaemic events (<3mmol/l) during the 2 week intervention period
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03598400 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2018)
  • Mean glucose [ Time Frame: 2 weeks ]
    mean glucose level over 2 week recording period
  • % 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
  • % 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
  • % 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
  • % 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
  • % 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
  • glycaemic variability (coefficient of variation and Standard Deviation) [ Time Frame: 2 weeks ]
    glycaemic variability over 2 week recording period
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
  • Mean glucose [ Time Frame: 2 weeks ]
    mean glucose level over 2 week recording period
  • % 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
  • % 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
  • % 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
  • % 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
  • % 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
  • glycaemic variability (CV and SD) [ Time Frame: 2 weeks ]
    glycaemic variability over 2 week recording period
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HIT on Hypoglycemic Risk in Type 1 Diabetes (T1D)
Official Title  ICMJE Can High Intensity Interval Training Reduce Fear of Hypoglycaemia and Improve Glycaemic Control in People With Type 1 Diabetes?
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Type1diabetes
Intervention  ICMJE
  • 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.
  • Behavioral: 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.
Study Arms  ICMJE
  • No Intervention: Control
    Participants will continue with their habitual lifestyle but perform no exercise for 2 weeks
  • Active Comparator: Moderate intensity continous training
    Participants will complete moderate intensity continous training during a 2 week intervention period
    Intervention: Behavioral: moderate intensity continous training
  • Experimental: high intensity interval training
    Participants will complete high intensity interval training during a 2 week intervention period
    Intervention: Behavioral: high intensity interval training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 24, 2018)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2019
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Matthew Cocks 07540191292 m.s.cocks@ljmu.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03598400
Other Study ID Numbers  ICMJE T1D1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No individual participant data will be shared outside the research team. Anonymised group data will be presented in research articles and presentations
Responsible Party Liverpool John Moores University
Study Sponsor  ICMJE Liverpool John Moores University
Collaborators  ICMJE
  • Society for Endocrinology
  • Royal Liverpool University Hospital
  • University of Birmingham
  • University of Exeter
Investigators  ICMJE Not Provided
PRS Account Liverpool John Moores University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP