- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01962857
Effect of 4 Weeks of Shuttle Run Training on Insulin Sensitivity in Sedentary Men
June 2, 2016 updated by: Dr Jason Gill, University of Glasgow
A number of studies have shown that short duration, high intensity interval training can improve health-related outcomes, such as insulin sensitivity and cardiorespiratory fitness.
However, these often use specialized equipment, such as cycle ergometers, which makes it difficult to roll these interventions out for wide-scale use in the general population.
This study aims evaluate the effects of a high intensity shuttle running intervention on insulin sensitivity, fitness and related cardiometabolic risk factors in men who are currently inactive.
Participants will be randomized into intervention (4 weeks of shuttle running) and control groups.
We hypothesize that the shuttle running programme will result in improved insulin sensitivity, fitness and increased fat oxidation at rest compared with the control group.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
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
-
-
-
Glasgow, United Kingdom, G12 8QQ
- University of Glasgow
-
-
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
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- male
- 18-40 years
- undertaking < 1 hour per week of planned exercise
Exclusion Criteria:
- BMI > 35 kg/m2
- Blood pressure > 160/90 mm Hg (on anti-hypertensive medication)
- history of established coronary heart disease
- family history of early cardiac death (<40 years)
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise
4 week supervised high-intensity shuttle running intervention, with 3 sessions per week (12 sessions in total)
|
4-week supervised high intensity shuttle running intervention, 3 sessions per week (12 sessions in total)
|
|
No Intervention: Control
No intervention - participants maintain usual lifestyle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Insulin sensitivity
Time Frame: Change from baseline immediately post-intervention (4 weeks after baseline)
|
Assessed from glucose and insulin concentrations in fasted state and during oral glucose tolerance test.
|
Change from baseline immediately post-intervention (4 weeks after baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resting substrate utilization
Time Frame: Change from baseline immediately post-intervention (4 weeks after baseline)
|
Metabolic rate and fat and carbohydrate oxidation estimated via indirect calorimetry
|
Change from baseline immediately post-intervention (4 weeks after baseline)
|
|
Endurance exercise performance
Time Frame: Change from baseline immediately post-intervention (4 weeks after baseline)
|
Time taken to complete 100 x 10m shuttle runs
|
Change from baseline immediately post-intervention (4 weeks after baseline)
|
|
Sprint exercise performance
Time Frame: Change from baseline immediately post-intervention (4 weeks after baseline)
|
Time taken to complete 10 x 10m shuttle runs
|
Change from baseline immediately post-intervention (4 weeks after baseline)
|
|
Body weight
Time Frame: Change from baseline immediately post-intervention (4 weeks after baseline)
|
Change from baseline immediately post-intervention (4 weeks after baseline)
|
|
|
Waist circumference
Time Frame: Change from baseline immediately post-intervention (4 weeks after baseline)
|
Change from baseline immediately post-intervention (4 weeks after baseline)
|
|
|
Percentage body fat
Time Frame: Change from baseline immediately post-intervention (4 weeks after baseline)
|
Change from baseline immediately post-intervention (4 weeks after baseline)
|
|
|
Clustered Cardiometabolic Risk Score
Time Frame: Change from baseline immediately post-intervention (4 weeks after baseline)
|
Clustered Cardiometabolic Risk Score = -zHDL+zInsulin+zGlucose+zTriglycerides+( zBMI+zWC)/2+(zSBP+zDBP)/2.
|
Change from baseline immediately post-intervention (4 weeks after baseline)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objectively measured physical activity
Time Frame: Change from baseline to week 4 of intervention
|
Time spent sedentary and physically active assessed by accelerometer
|
Change from baseline to week 4 of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
October 1, 2013
Primary Completion (Anticipated)
July 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
October 8, 2013
First Submitted That Met QC Criteria
October 10, 2013
First Posted (Estimate)
October 14, 2013
Study Record Updates
Last Update Posted (Estimate)
June 3, 2016
Last Update Submitted That Met QC Criteria
June 2, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FBLS1020
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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