- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01987258
The Acute Effect of Interval-walking (acute IWS)
Four months of interval walking training (IWT) is superior to energy-expenditure matched continuous walking training (CWT) with regards to weight loss and improvements in glycemic control. The reason for this is unclear. One potential explanation for the differential outcome in weight loss is excess post-exercise oxygen consumption (EPOC), which is defined as the elevated oxygen consumption measured during the hours following an exercise bout. A large EPOC means greater energy expenditure which, if energy intake does not change, leads to a greater weight loss. This weight loss may subsequently improve glycemic control
- Aim 1: To assess the effect of an acute bout of IWT vs. an acute bout of CWT on glycemic control in type 2 diabetics and to assess mechanisms responsible for differences (if any). It is hypothesised that IWT will be more advantageous for improving glycemic control.
- Aim 2: To examine the effect of an acute bout of IWT vs. an acute bout of CWT on EPOC. It is hypothesised that IWT will produce an EPOC of larger magnitude than CWT.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Copenhagen, Denmark, 2100
- Centre of Inflammation and Metabolism (CIM), Rigshospitalet, Tagensvej 20, section M7641
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diabetes mellitus, type 2
Exclusion Criteria:
- Smoking
- Pregnancy
- insulin dependence
- Contraindication to physical activity (as judged by medical history and screening)
- Evidence of thyroid, liver, lung, kidney or heart disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
No exercise (control experiment)
|
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Experimental: Interval Walking
A one hour interval walking exercise bout
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Other Names:
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Experimental: Continuous walking
A one hour continuous walking exercise bout
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycemic control
Time Frame: Will be assessed immediately after the intervention using a mixed meal tolerance test (duration: 5 hours) followed by continuous glucose monitoring (duration: 48 hours).
|
Glycemic control will be assessed after a one hour specific exercise intervention (control/continuous walking/interval walking) in a controlled setting (a mixed meal tolerance test).
Moreover, glycemic control will be assessed during the following 2 days in a free-living environment, using continuous glucose monitoring systems.
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Will be assessed immediately after the intervention using a mixed meal tolerance test (duration: 5 hours) followed by continuous glucose monitoring (duration: 48 hours).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Excess post-exercise oxygen consumption (EPOC)
Time Frame: Will be assessed immediately after the intervention using a ventilated hood (duration: 5 hours).
|
EPOC will be assessed during the hours following the before-mentioned specific exercise bouts using the indirect calorimetry ventilated hood technique.
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Will be assessed immediately after the intervention using a ventilated hood (duration: 5 hours).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kristian Karstoft, MD, Centre of Inflammation and Metabolism (CIM), Rigshospitalet, Tagensvej 20, section M7641, DK-2100 Copenhagen, Denmark
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-3-2012-141
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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