Insulin ResistanceNCT01962857
Effect of 4 Weeks of Shuttle Run Training on Insulin Sensitivity in Sedentary Men
A study testing Exercise in people with Insulin Resistance and Obesity, run by University of Glasgow at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Obesity, Metabolic Syndrome
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2013to Dec 2017
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- 18-40 years
- undertaking < 1 hour per week of planned exercise
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Insulin Resistance, Obesity, Metabolic Syndrome
- Being tested
- Exercise
- Keywords
- Physical activity, Exercise, Insulin resistance, High intensity interval training, Fat oxidation, Fitness, Lipids, Blood pressure
- Medical subject headings
- Insulin Resistance, Obesity, Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
4-week supervised high intensity shuttle running intervention, 3 sessions per week (12 sessions in total)
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 4 week supervised high-intensity shuttle running intervention, with 3 sessions per week (12 sessions in total) Receives: Behavioral: Exercise |
| Control | No intervention | No intervention - participants maintain usual lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Assessed from glucose and insulin concentrations in fasted state and during oral glucose tolerance test.
Measured: Change from baseline immediately post-intervention (4 weeks after baseline)
Secondary outcomes (7)
Resting substrate utilization
Metabolic rate and fat and carbohydrate oxidation estimated via indirect calorimetry
Measured: Change from baseline immediately post-intervention (4 weeks after baseline)
Endurance exercise performance
Time taken to complete 100 x 10m shuttle runs
Measured: Change from baseline immediately post-intervention (4 weeks after baseline)
Sprint exercise performance
Time taken to complete 10 x 10m shuttle runs
Measured: Change from baseline immediately post-intervention (4 weeks after baseline)
Body weight
Measured: Change from baseline immediately post-intervention (4 weeks after baseline)
Waist circumference
Measured: Change from baseline immediately post-intervention (4 weeks after baseline)
Percentage body fat
Measured: Change from baseline immediately post-intervention (4 weeks after baseline)
Clustered Cardiometabolic Risk Score
Clustered Cardiometabolic Risk Score = -zHDL+zInsulin+zGlucose+zTriglycerides+( zBMI+zWC)/2+(zSBP+zDBP)/2.
Measured: Change from baseline immediately post-intervention (4 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: No member of staff available for active recruitment at the moment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jason Gill, University of Glasgow
- Investigators
- Jason Gill, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962857
- Sponsor's protocol ID
- FBLS1020
- Status last verified
- Jun 2016
- First submitted
- 8 Oct 2013
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 4 Weeks of Shuttle Run Training on Insulin Sensitivity in Sedentary Men
- ClinicalTrials.gov ID
- NCT01962857
- Acronym / sponsor ID
- FBLS1020
- Conditions
- Insulin Resistance, Obesity, Metabolic Syndrome
- Keywords
- Physical activity, Exercise, Insulin resistance, High intensity interval training, Fat oxidation, Fitness, Lipids, Blood pressure
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: No member of staff available for active recruitment at the moment
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise4 week supervised high-intensity shuttle running intervention, with 3 sessions per week (12 sessions in total) |
| Control | No intervention | –No intervention - participants maintain usual lifestyle |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- male
- 18-40 years
- undertaking < 1 hour per week of planned exercise
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise4-week supervised high intensity shuttle running intervention, 3 sessions per week (12 sessions in total) | Behavioural | Exercise |
Primary outcome
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.
7 secondary outcomes
Resting substrate utilization
Time frame: 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)
Sprint exercise performance
Time frame: Change from baseline immediately post-intervention (4 weeks after baseline)
Body weight
Time frame: Change from baseline immediately post-intervention (4 weeks after baseline)
Waist circumference
Time frame: 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)
Clustered Cardiometabolic Risk Score
Time frame: Change from baseline immediately post-intervention (4 weeks after baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Gill, PhD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Insulin Resistance and Obesity, run by University of Glasgow 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 3 inclusion and 4 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: paused, as of the sponsor's last update on 3 Jun 2016. 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?
Results are not available in the source record.
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?
Insulin sensitivity (time frame: Change from baseline immediately post-intervention (4 weeks after baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2016.