Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

HIT on Hypoglycemic Risk in Type 1 Diabetes (T1D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03598400
Recruitment Status : Completed
First Posted : July 26, 2018
Last Update Posted : February 23, 2021
Sponsor:
Collaborators:
Society for Endocrinology
Royal Liverpool University Hospital
University of Birmingham
University of Exeter
Information provided by (Responsible Party):
Liverpool John Moores University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Recent work (unpublished) from our lab suggests high intensity interval training (HIT) may reduce the risk of hypoglycaemia in people with type 1 diabetes, however stronger evidence is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.


Condition or disease Intervention/treatment Phase
Type1diabetes Behavioral: high intensity interval training Behavioral: moderate intensity continous training Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Can High Intensity Interval Training Reduce Fear of Hypoglycaemia and Improve Glycaemic Control in People With Type 1 Diabetes?
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : August 1, 2020
Actual Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
 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.
Experimental: high intensity interval training
Participants will complete high intensity interval training during a 2 week intervention period
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Severe hypoglycaemia [ Time Frame: 2 weeks ]
    Number of severe hypoglycaemic events (<3mmol/l) during the 2 week intervention period


Secondary Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598400


Locations
Layout table for location information
United Kingdom
Liverpool John Moores University
Liverpool, United Kingdom, L33AF
Sponsors and Collaborators
Liverpool John Moores University
Society for Endocrinology
Royal Liverpool University Hospital
University of Birmingham
University of Exeter
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Liverpool John Moores University
ClinicalTrials.gov Identifier: NCT03598400    
Other Study ID Numbers: T1D1
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases