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Type 1 Diabetes MellitusPET1DNCT03285386

Priming Exercise in Type 1 Diabetes

A study testing Priming exercise in people with Type 1 Diabetes Mellitus, run by Liverpool Hope University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, men only
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Priming exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited Kingdom
Study dates
1 Jan 2018to 1 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Liverpool Hope University

    Liverpool, Merseyside, L169JD

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
Priming exercise, Control Exercise
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Priming exerciseBehavioural

    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.

  • Control ExerciseBehavioural

    All participants will perform 3 minutes of baseline cycling prior to undertaking an exhaustive exercise test on four separate occasions.

Study groups in NCT03285386
Study groupRoleWhat they receive
Priming ExerciseExperimentalParticipants 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.
Receives: Behavioral: Priming exercise
ControlActive comparatorParticipants 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.
Receives: Behavioral: Control Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Critical power

    The power asymptote of the hyperbolic relationship between power and the tolerable duration of exercise.

    Measured: 3-9 weeks

  2. Phase II time constant of pulmonary oxygen uptake kinetics

    Time taken for oxygen uptake to attain 63% of its asymptotic amplitude.

    Measured: 3-9 weeks

  3. Time constant for muscle deoxygenation kinetics (assessed by near-infrared spectroscopy)

    Time taken for muscle deoxyhaemoglobin to attain 63% of its asymptotic amplitude.

    Measured: 3-9 weeks

Secondary outcomes (2)

  1. W'

    Curvature constant of the power-duration relationship. Finite work capacity available above critical power.

    Measured: 3-9 weeks

  2. Time constant for heart rate kinetics

    Time taken for heart rate to attain 63% of its asymptotic amplitude.

    Measured: 3-9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2017
  2. Study start1 Jan 2018
  3. Primary completion1 Dec 2018
  4. Study completion1 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Single group
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)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03285386
Sponsor's protocol ID
LiverpoolHopeUni
Acronym
PET1D
Status last verified
Feb 2019
First submitted
14 Sep 2017
Last updated
1 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 28627041

  • 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.

    PubMed 12181120

  • 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.

    PubMed 8184927

  • 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.

    PubMed 9574868

  • 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.

    PubMed 21552161

Questions about this trial

What is this clinical trial studying?

A study testing Priming exercise in people with Type 1 Diabetes Mellitus, run by Liverpool Hope University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Critical power (time frame: 3-9 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03285386, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.

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