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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01962857
• Other study ID #: FBLS1020
• Status: Suspended
• Phase: N/A
• First received: October 8, 2013
• Last updated: June 2, 2016
• Start date: October 2013
• Est. completion date: December 2017

Study information

• Verified date: June 2016
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Intervention

Behavioral:
• Exercise
4-week supervised high intensity shuttle running intervention, 3 sessions per week (12 sessions in total)

Locations

Country	Name	City	State
United Kingdom	University of Glasgow	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Objectively measured physical activity	Time spent sedentary and physically active assessed by accelerometer	Change from baseline to week 4 of intervention	No
Primary	Insulin sensitivity	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)	No
Secondary	Resting substrate utilization	Metabolic rate and fat and carbohydrate oxidation estimated via indirect calorimetry	Change from baseline immediately post-intervention (4 weeks after baseline)	No
Secondary	Endurance exercise performance	Time taken to complete 100 x 10m shuttle runs	Change from baseline immediately post-intervention (4 weeks after baseline)	No
Secondary	Sprint exercise performance	Time taken to complete 10 x 10m shuttle runs	Change from baseline immediately post-intervention (4 weeks after baseline)	No
Secondary	Body weight		Change from baseline immediately post-intervention (4 weeks after baseline)	No
Secondary	Waist circumference		Change from baseline immediately post-intervention (4 weeks after baseline)	No
Secondary	Percentage body fat		Change from baseline immediately post-intervention (4 weeks after baseline)	No
Secondary	Clustered Cardiometabolic Risk Score	Clustered Cardiometabolic Risk Score = -zHDL+zInsulin+zGlucose+zTriglycerides+( zBMI+zWC)/2+(zSBP+zDBP)/2.	Change from baseline immediately post-intervention (4 weeks after baseline)	No