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Priming Exercise in Type 1 Diabetes (PET1D)

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Priming exercise
Control Exercise
Sponsored by
Liverpool Hope University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - 40 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Suffering from Type 1 diabetes with a diagnosed disease duration of 2 - 20 years and no comorbidities.

Exclusion Criteria:

History of stroke, congestive heart failure, hypertension, or cardiopulmonary disease.

Current smoking or have been smoking within the last 12 months Symptomatic autonomic or distal neuropathy HbA1c > 64 mmol/mol Hypoglycaemia unawareness in the last 6 months Taking any medications other than insulin.

Sites / Locations

  • Liverpool Hope University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Priming Exercise

Control

Arm Description

Participants will perform constant power output tests at four separate, fixed intensities to exhaustion on a cycle ergometer on separate days. These exhaustive, constant power tests will be preceded by 3 minutes of light cycling, 6 minutes of high intensity cycling, 7 minutes of rest and 3 minutes of light cycling.

Participants will perform constant power output tests at four separate, fixed intensities to exhaustion on a cycle ergometer on separate days. These exhaustive, constant power tests will be preceded by 3 minutes of light cycling only.

Outcomes

Primary Outcome Measures

Critical power
The power asymptote of the hyperbolic relationship between power and the tolerable duration of exercise.
Phase II time constant of pulmonary oxygen uptake kinetics
Time taken for oxygen uptake to attain 63% of its asymptotic amplitude.
Time constant for muscle deoxygenation kinetics (assessed by near-infrared spectroscopy)
Time taken for muscle deoxyhaemoglobin to attain 63% of its asymptotic amplitude.

Secondary Outcome Measures

W'
Curvature constant of the power-duration relationship. Finite work capacity available above critical power.
Time constant for heart rate kinetics
Time taken for heart rate to attain 63% of its asymptotic amplitude.

Full Information

First Posted
September 14, 2017
Last Updated
February 28, 2019
Sponsor
Liverpool Hope University
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1. Study Identification

Unique Protocol Identification Number
NCT03285386
Brief Title
Priming Exercise in Type 1 Diabetes
Acronym
PET1D
Official Title
The Effects of Prior Exercise on Pulmonary Oxygen Uptake Kinetics and the Power-Duration Relationship in Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool Hope University

4. Oversight

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

5. Study Description

Brief Summary
Critical power is an important threshold in exercise physiology, and is an important determinant of the ability to tolerate high-intensity exercise. The ability to tolerate such exercise is drastically impaired in certain chronic conditions, such as type 1 diabetes. Whilst the most important physiological factors that determine critical power have yet to be determined, previous work from our laboratory suggests that it is related to the speed of oxygen uptake at the onset of exercise. This study will look to utilise "priming" exercise as an intervention to improve the speed of these oxygen uptake "kinetics", and thus critical power and exercise tolerance in individuals with type 1 diabetes. We hypothesize that oxygen uptake kinetics will be faster and critical power will be higher when exercise is performed with compared to without a prior bout of high-intensity priming exercise in a population of individuals with type 1 diabetes.
Detailed Description
The ability to tolerate high-intensity exercise, or exercise tolerance, is a key factor that can influence clinical outcomes in a range of conditions. The "critical power" is an important physiological threshold that demarcates exercise intensities that can be sustained for prolonged periods (i.e. below critical power) from intensities that result in exhaustion in a relatively short period of time (i.e. 2-30 minutes, above critical power). Critical power is therefore a key determinant of exercise tolerance. The speed with which oxygen uptake rises at the onset of exercise (i.e. oxygen uptake "kinetics") has been shown by work from our laboratory to be a key determinant of critical power. One intervention that can acutely improve the oxygen uptake kinetics is the performance of a prior bout of high-intensity exercise, known as "priming exercise". Patients with type 1 diabetes have previously been shown to have impaired exercise tolerance compared to healthy controls. The performance of priming exercise therefore represents a potential intervention to acutely improve oxygen uptake kinetics, and therefore critical power and exercise tolerance, in type 1 diabetic individuals. The purpose of this study is therefore to assess the influence of priming exercise on oxygen uptake kinetics and critical power in a population of type 1 diabetic individuals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants will serve as their own controls. Participants will alternate between "primed" (experimental condition) and "non-primed" (control condition) in their visits.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Priming Exercise
Arm Type
Experimental
Arm Description
Participants will perform constant power output tests at four separate, fixed intensities to exhaustion on a cycle ergometer on separate days. These exhaustive, constant power tests will be preceded by 3 minutes of light cycling, 6 minutes of high intensity cycling, 7 minutes of rest and 3 minutes of light cycling.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants will perform constant power output tests at four separate, fixed intensities to exhaustion on a cycle ergometer on separate days. These exhaustive, constant power tests will be preceded by 3 minutes of light cycling only.
Intervention Type
Behavioral
Intervention Name(s)
Priming exercise
Intervention Description
All participants will perform a bout of high-intensity "priming" exercise for 6 minutes, 10 minutes prior to undertaking an exhaustive exercise test on four separate occasions.
Intervention Type
Behavioral
Intervention Name(s)
Control Exercise
Intervention Description
All participants will perform 3 minutes of baseline cycling prior to undertaking an exhaustive exercise test on four separate occasions.
Primary Outcome Measure Information:
Title
Critical power
Description
The power asymptote of the hyperbolic relationship between power and the tolerable duration of exercise.
Time Frame
3-9 weeks
Title
Phase II time constant of pulmonary oxygen uptake kinetics
Description
Time taken for oxygen uptake to attain 63% of its asymptotic amplitude.
Time Frame
3-9 weeks
Title
Time constant for muscle deoxygenation kinetics (assessed by near-infrared spectroscopy)
Description
Time taken for muscle deoxyhaemoglobin to attain 63% of its asymptotic amplitude.
Time Frame
3-9 weeks
Secondary Outcome Measure Information:
Title
W'
Description
Curvature constant of the power-duration relationship. Finite work capacity available above critical power.
Time Frame
3-9 weeks
Title
Time constant for heart rate kinetics
Description
Time taken for heart rate to attain 63% of its asymptotic amplitude.
Time Frame
3-9 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Suffering from Type 1 diabetes with a diagnosed disease duration of 2 - 20 years and no comorbidities. Exclusion Criteria: History of stroke, congestive heart failure, hypertension, or cardiopulmonary disease. Current smoking or have been smoking within the last 12 months Symptomatic autonomic or distal neuropathy HbA1c > 64 mmol/mol Hypoglycaemia unawareness in the last 6 months Taking any medications other than insulin.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richie P Goulding
Organizational Affiliation
Liverpool Hope University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liverpool Hope University
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L169JD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Anonymized participant data will be made available to the public in the form of research presentations and a journal article. Anonymized individual participant data not featured in either the journal article or presentations will only be made available upon request to the authors.
Citations:
PubMed Identifier
28627041
Citation
Goulding RP, Roche DM, Marwood S. Prior exercise speeds pulmonary oxygen uptake kinetics and increases critical power during supine but not upright cycling. Exp Physiol. 2017 Sep 1;102(9):1158-1176. doi: 10.1113/EP086304. Epub 2017 Jul 26.
Results Reference
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PubMed Identifier
12181120
Citation
Behnke BJ, Kindig CA, McDonough P, Poole DC, Sexton WL. Dynamics of microvascular oxygen pressure during rest-contraction transition in skeletal muscle of diabetic rats. Am J Physiol Heart Circ Physiol. 2002 Sep;283(3):H926-32. doi: 10.1152/ajpheart.00059.2002.
Results Reference
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PubMed Identifier
8184927
Citation
Sexton WL, Poole DC, Mathieu-Costello O. Microcirculatory structure-function relationships in skeletal muscle of diabetic rats. Am J Physiol. 1994 Apr;266(4 Pt 2):H1502-11. doi: 10.1152/ajpheart.1994.266.4.H1502. Erratum In: Am J Physiol 1994 Jun;266(6 Pt 2):section H followi.
Results Reference
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PubMed Identifier
9574868
Citation
Kindig CA, Sexton WL, Fedde MR, Poole DC. Skeletal muscle microcirculatory structure and hemodynamics in diabetes. Respir Physiol. 1998 Feb;111(2):163-75. doi: 10.1016/s0034-5687(97)00122-9.
Results Reference
background
PubMed Identifier
21552161
Citation
Burnley M, Davison G, Baker JR. Effects of priming exercise on VO2 kinetics and the power-duration relationship. Med Sci Sports Exerc. 2011 Nov;43(11):2171-9. doi: 10.1249/MSS.0b013e31821ff26d.
Results Reference
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Priming Exercise in Type 1 Diabetes

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