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Fasted Exercise in People With Type 1 Diabetes

Primary Purpose

Type1diabetes

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Effects of the type of exercise on blood glucose concentrations
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

18 Years - 55 Years (Adult)All SexesAccepts 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 and
  • unstable proliferative retinopathy

Sites / Locations

  • Liverpool John Moores University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Control day with no exercise

High intensity interval training (HIT)

moderate intensity continuous training (MICT)

Arm Description

glycaemic profile will be assessed using continuous glucose monitors following a single 24-hour period in which participants performed no exercise

glycaemic profile will be assessed using continuous glucose monitors following a 24-hour period whereby participants performed a single bout of high-intensity interval training (HIT) in the morning under fasted conditions

glycaemic profile will be assessed using continuous glucose monitors following a 24-hour period whereby participants performed a single bout of moderate-intensity continuous training (MICT) in the morning under fasted conditions

Outcomes

Primary Outcome Measures

24 hour glycaemic profile
Continuous glucose monitoring will be used to assess the effects of an acute bout of fasted high intensity interval training or moderate intensity continuous training on 24 hour glycaemic profile.

Secondary Outcome Measures

Full Information

First Posted
May 9, 2018
Last Updated
June 7, 2018
Sponsor
Liverpool John Moores University
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1. Study Identification

Unique Protocol Identification Number
NCT03544684
Brief Title
Fasted Exercise in People With Type 1 Diabetes
Official Title
Fasted High-Intensity Interval and Moderate-Intensity Continuous Exercise Are Not Associated With A Detrimental 24-Hour Blood Glucose Profile
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
This study aims to compare the effect of a bout of high-intensity interval training (HIT) with a bout of moderate-intensity continuous training (MICT) on glucose concentrations over the subsequent 24h period.
Detailed Description
This study aims to compare the effect of a bout of high-intensity interval training (HIT) with a bout of moderate-intensity continuous training (MICT) on glucose concentrations over the subsequent 24h period. Fourteen people with type 1 diabetes (duration of type 1 diabetes 8.2±1.4 years), all on basal-bolus regimen, completed a randomised, counterbalanced, crossover study. Continuous glucose monitoring was used to assess glycaemic control following a single bout of HIT (6 x 1min intervals) and 30 mins of moderate-intensity continuous training (MICT) on separate days, compared to a non-exercise control day (CON). Exercise was undertaken following an overnight fast with omission of short-acting insulin. Capillary blood glucose samples were recorded pre and post-exercise to assess the acute changes in glycaemia during HIT and MICT.

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
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control day with no exercise
Arm Type
Experimental
Arm Description
glycaemic profile will be assessed using continuous glucose monitors following a single 24-hour period in which participants performed no exercise
Arm Title
High intensity interval training (HIT)
Arm Type
Experimental
Arm Description
glycaemic profile will be assessed using continuous glucose monitors following a 24-hour period whereby participants performed a single bout of high-intensity interval training (HIT) in the morning under fasted conditions
Arm Title
moderate intensity continuous training (MICT)
Arm Type
Experimental
Arm Description
glycaemic profile will be assessed using continuous glucose monitors following a 24-hour period whereby participants performed a single bout of moderate-intensity continuous training (MICT) in the morning under fasted conditions
Intervention Type
Behavioral
Intervention Name(s)
Effects of the type of exercise on blood glucose concentrations
Intervention Description
glucose concentrations were assessed over the 24 hour periods following no exercise, a single bout of high intensity interval training and a single bout of moderate intensity continuous training
Primary Outcome Measure Information:
Title
24 hour glycaemic profile
Description
Continuous glucose monitoring will be used to assess the effects of an acute bout of fasted high intensity interval training or moderate intensity continuous training on 24 hour glycaemic profile.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 and 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
There is no plan to make individual data available to others
Citations:
PubMed Identifier
30281094
Citation
Scott SN, Cocks M, Andrews RC, Narendran P, Purewal TS, Cuthbertson DJ, Wagenmakers AJM, Shepherd SO. High-Intensity Interval Training Improves Aerobic Capacity Without a Detrimental Decline in Blood Glucose in People With Type 1 Diabetes. J Clin Endocrinol Metab. 2019 Feb 1;104(2):604-612. doi: 10.1210/jc.2018-01309.
Results Reference
derived
PubMed Identifier
30252054
Citation
Scott SN, Cocks M, Andrews RC, Narendran P, Purewal TS, Cuthbertson DJ, Wagenmakers AJM, Shepherd SO. Fasted High-Intensity Interval and Moderate-Intensity Exercise Do Not Lead to Detrimental 24-Hour Blood Glucose Profiles. J Clin Endocrinol Metab. 2019 Jan 1;104(1):111-117. doi: 10.1210/jc.2018-01308.
Results Reference
derived

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Fasted Exercise in People With Type 1 Diabetes

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