Priming Exercise in Type 1 Diabetes (PET1D)

February 28, 2019 updated by: Liverpool Hope University

The Effects of Prior Exercise on Pulmonary Oxygen Uptake Kinetics and the Power-Duration Relationship in Type 1 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

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

  • United Kingdom
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L169JD
        • Liverpool Hope 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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Priming Exercise
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.
Behavioral: Priming exercise
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.
Active Comparator: Control
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.
Behavioral: Control Exercise
All participants will perform 3 minutes of baseline cycling prior to undertaking an exhaustive exercise test on four separate occasions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Critical power
Time Frame: 3-9 weeks
The power asymptote of the hyperbolic relationship between power and the tolerable duration of exercise.
3-9 weeks
Phase II time constant of pulmonary oxygen uptake kinetics
Time Frame: 3-9 weeks
Time taken for oxygen uptake to attain 63% of its asymptotic amplitude.
3-9 weeks
Time constant for muscle deoxygenation kinetics (assessed by near-infrared spectroscopy)
Time Frame: 3-9 weeks
Time taken for muscle deoxyhaemoglobin to attain 63% of its asymptotic amplitude.
3-9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
W'
Time Frame: 3-9 weeks
Curvature constant of the power-duration relationship. Finite work capacity available above critical power.
3-9 weeks
Time constant for heart rate kinetics
Time Frame: 3-9 weeks
Time taken for heart rate to attain 63% of its asymptotic amplitude.
3-9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liverpool Hope University

Investigators

  • Principal Investigator: Richie P Goulding, Liverpool Hope University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2018

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

September 14, 2017

First Submitted That Met QC Criteria

September 14, 2017

First Posted (Actual)

September 18, 2017

Study Record Updates

Last Update Posted (Actual)

March 1, 2019

Last Update Submitted That Met QC Criteria

February 28, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LiverpoolHopeUni

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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.

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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