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HIT in People With Type 1 Diabetes

Primary Purpose

Type1diabetes

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
HIT
MICT
Sponsored by
Liverpool John Moores University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type1diabetes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

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

Sites / Locations

  • Liverpool John Moores University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

HIT training

Moderate intensity training

Arm Description

6 weeks of high-intensity interval training (HIT)

6 weeks of moderate-intensity continuous training (MICT)

Outcomes

Primary Outcome Measures

Maximal aerobic capacity
Maximal aerobic capacity test pre and post 6-week training intervention

Secondary Outcome Measures

Vascular stiffness
Aortic pulse wave velocity to measure vascular stiffness

Full Information

First Posted
May 9, 2018
Last Updated
June 1, 2018
Sponsor
Liverpool John Moores University
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1. Study Identification

Unique Protocol Identification Number
NCT03545841
Brief Title
HIT in People With Type 1 Diabetes
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 9, 2015 (Actual)
Primary Completion Date
October 10, 2017 (Actual)
Study Completion Date
October 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liverpool John Moores University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIT training
Arm Type
Experimental
Arm Description
6 weeks of high-intensity interval training (HIT)
Arm Title
Moderate intensity training
Arm Type
Experimental
Arm Description
6 weeks of moderate-intensity continuous training (MICT)
Intervention Type
Other
Intervention Name(s)
HIT
Intervention Description
Participants completed 6 weeks of HIT
Intervention Type
Other
Intervention Name(s)
MICT
Intervention Description
Participants completed 6 weeks of MICT
Primary Outcome Measure Information:
Title
Maximal aerobic capacity
Description
Maximal aerobic capacity test pre and post 6-week training intervention
Time Frame
change in baseline maximal aerobic capacity at 6 weeks
Secondary Outcome Measure Information:
Title
Vascular stiffness
Description
Aortic pulse wave velocity to measure vascular stiffness
Time Frame
change in baseline vascular stiffness at 6 weeks

10. Eligibility

Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Liverpool John Moores University
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L3 3AF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plans to make data available to others

Learn more about this trial

HIT in People With Type 1 Diabetes

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