NCT03285386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

September 14, 2017

Last Update Submit

February 28, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Critical power

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

    3-9 weeks

Secondary Outcomes (2)

  • W'

    3-9 weeks

  • Time constant for heart rate kinetics

    3-9 weeks

Study Arms (2)

Priming Exercise

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

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.

Priming Exercise

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

Control

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liverpool Hope University

Liverpool, Merseyside, L169JD, United Kingdom

Location

Related Publications (5)

  • 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.

    PMID: 28627041BACKGROUND
  • 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.

    PMID: 12181120BACKGROUND
  • 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.

    PMID: 8184927BACKGROUND
  • 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.

    PMID: 9574868BACKGROUND
  • 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.

    PMID: 21552161BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Richie P Goulding

    Liverpool Hope University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Participants will serve as their own controls. Participants will alternate between "primed" (experimental condition) and "non-primed" (control condition) in their visits.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 18, 2017

Study Start

January 1, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 1, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

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.

Locations