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Effect of 4 Weeks of Shuttle Run Training on Insulin Sensitivity in Sedentary Men

Primary Purpose

Insulin Resistance, Obesity, Metabolic Syndrome

Status
Suspended
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Glasgow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Insulin Resistance focused on measuring Physical activity, Exercise, Insulin resistance, High intensity interval training, Fat oxidation, Fitness, Lipids, Blood pressure

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Glasgow

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Control

Arm Description

4 week supervised high-intensity shuttle running intervention, with 3 sessions per week (12 sessions in total)

No intervention - participants maintain usual lifestyle

Outcomes

Primary Outcome Measures

Insulin sensitivity
Assessed from glucose and insulin concentrations in fasted state and during oral glucose tolerance test.

Secondary Outcome Measures

Resting substrate utilization
Metabolic rate and fat and carbohydrate oxidation estimated via indirect calorimetry
Endurance exercise performance
Time taken to complete 100 x 10m shuttle runs
Sprint exercise performance
Time taken to complete 10 x 10m shuttle runs
Body weight
Waist circumference
Percentage body fat
Clustered Cardiometabolic Risk Score
Clustered Cardiometabolic Risk Score = -zHDL+zInsulin+zGlucose+zTriglycerides+( zBMI+zWC)/2+(zSBP+zDBP)/2.

Full Information

First Posted
October 8, 2013
Last Updated
June 2, 2016
Sponsor
University of Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT01962857
Brief Title
Effect of 4 Weeks of Shuttle Run Training on Insulin Sensitivity in Sedentary Men
Official Title
Effect of 4 Weeks of Shuttle Run Training on Insulin Sensitivity in Sedentary Men
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Suspended
Why Stopped
No member of staff available for active recruitment at the moment
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Glasgow

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Obesity, Metabolic Syndrome
Keywords
Physical activity, Exercise, Insulin resistance, High intensity interval training, Fat oxidation, Fitness, Lipids, Blood pressure

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
4 week supervised high-intensity shuttle running intervention, with 3 sessions per week (12 sessions in total)
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention - participants maintain usual lifestyle
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
4-week supervised high intensity shuttle running intervention, 3 sessions per week (12 sessions in total)
Primary Outcome Measure Information:
Title
Insulin sensitivity
Description
Assessed from glucose and insulin concentrations in fasted state and during oral glucose tolerance test.
Time Frame
Change from baseline immediately post-intervention (4 weeks after baseline)
Secondary Outcome Measure Information:
Title
Resting substrate utilization
Description
Metabolic rate and fat and carbohydrate oxidation estimated via indirect calorimetry
Time Frame
Change from baseline immediately post-intervention (4 weeks after baseline)
Title
Endurance exercise performance
Description
Time taken to complete 100 x 10m shuttle runs
Time Frame
Change from baseline immediately post-intervention (4 weeks after baseline)
Title
Sprint exercise performance
Description
Time taken to complete 10 x 10m shuttle runs
Time Frame
Change from baseline immediately post-intervention (4 weeks after baseline)
Title
Body weight
Time Frame
Change from baseline immediately post-intervention (4 weeks after baseline)
Title
Waist circumference
Time Frame
Change from baseline immediately post-intervention (4 weeks after baseline)
Title
Percentage body fat
Time Frame
Change from baseline immediately post-intervention (4 weeks after baseline)
Title
Clustered Cardiometabolic Risk Score
Description
Clustered Cardiometabolic Risk Score = -zHDL+zInsulin+zGlucose+zTriglycerides+( zBMI+zWC)/2+(zSBP+zDBP)/2.
Time Frame
Change from baseline immediately post-intervention (4 weeks after baseline)
Other Pre-specified Outcome Measures:
Title
Objectively measured physical activity
Description
Time spent sedentary and physically active assessed by accelerometer
Time Frame
Change from baseline to week 4 of intervention

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Gill, PhD
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Glasgow
City
Glasgow
ZIP/Postal Code
G12 8QQ
Country
United Kingdom

12. IPD Sharing Statement

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Effect of 4 Weeks of Shuttle Run Training on Insulin Sensitivity in Sedentary Men

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