- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03545841
HIT in People With Type 1 Diabetes
June 1, 2018 updated by: Sam Shepherd, Liverpool John Moores University
High-Intensity Interval Training Improves Aerobic Capacity and Abolishes the Decline in Blood Glucose Observed During Moderate-Intensity Continuous Training Sessions in People With Type 1 Diabetes
Few people with type 1 diabetes achieve exercise guidelines and many programmes designed to increase physical activity have failed.
High-intensity interval training (HIT) has been shown to be a time-efficient alternative to traditional moderate-intensity continuous training (MICT) in various groups without type 1 diabetes.
A single bout of HIT does not increase the risk of hypoglycaemia in people with type 1 diabetes.
This study aimed to assess whether HIT a safe, effective and time-efficient training strategy to improve cardio-metabolic health and reduce the risk of hypoglycaemia in people with type 1 diabetes.
Study Overview
Detailed Description
This study aimed to investigate whether 1) six weeks of high-intensity interval training (HIT) induces similar improvements in cardio-metabolic health markers as moderate-intensity continuous training (MICT) in people with type 1 diabetes, and 2) whether HIT abolishes acute reductions in plasma glucose observed following MICT sessions.
Fourteen sedentary individuals with type 1 diabetes (n=7 per group) completed six weeks of HIT or MICT 3 times per week.
Pre- and post-training measurements were made of 24h interstitial glucose profiles (using continuous glucose monitors (CGMS)) and cardio-metabolic health markers (V ̇O2peak, blood lipid profile and aortic pulse wave velocity; aPWV).
Capillary blood glucose concentrations were assessed before and after exercise sessions throughout the training programme to investigate changes in blood glucose during exercise in the fed state.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Merseyside
-
Liverpool, Merseyside, United Kingdom, L3 3AF
- Liverpool John Moores University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- duration of type 1 diabetes >6 months
- basal bolus regimen
- no significant history of hyper- or hypoglycaemia (determined from medical history)
Exclusion Criteria:
duration of type 1 diabetes <6 months,
- insulin pump therapy
- significant history of hyper- or hypoglycaemia (determined from medical history)
- obesity (BMI >30 kg∙m-2)
- pregnancy or planning pregnancy
- uncontrolled hypertension (>180/100 mmHg)
- angina, autonomic neuropathy
- taking any medication that affects heart rate
- major surgery planned within 6 weeks of the study
- severe nonproliferative
- unstable proliferative retinopathy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HIT training
6 weeks of high-intensity interval training (HIT)
|
Participants completed 6 weeks of HIT
|
Experimental: Moderate intensity training
6 weeks of moderate-intensity continuous training (MICT)
|
Participants completed 6 weeks of MICT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal aerobic capacity
Time Frame: change in baseline maximal aerobic capacity at 6 weeks
|
Maximal aerobic capacity test pre and post 6-week training intervention
|
change in baseline maximal aerobic capacity at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vascular stiffness
Time Frame: change in baseline vascular stiffness at 6 weeks
|
Aortic pulse wave velocity to measure vascular stiffness
|
change in baseline vascular stiffness at 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 9, 2015
Primary Completion (Actual)
October 10, 2017
Study Completion (Actual)
October 10, 2017
Study Registration Dates
First Submitted
May 9, 2018
First Submitted That Met QC Criteria
June 1, 2018
First Posted (Actual)
June 4, 2018
Study Record Updates
Last Update Posted (Actual)
June 4, 2018
Last Update Submitted That Met QC Criteria
June 1, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T1D_PARTB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No plans to make data available to others
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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