- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02257190
The Features Behind the Beneficial Effects of Interval-walking (aIWS2)
A single bout of Interval-Walking (IW) exercise is superior to energy-expenditure and time-duration matched Continuous Walking (CW) exercise upon improving glycemic control. The reason IW is superior is unknown.
This study will look into whether it is the larger peak intensity during IW or if it is the alternating exercise pattern that is responsible for the larger improvements seen.
Subjects with type 2 diabetes will be included in a crossover, counter-balanced, controlled study, where each subject will undergo three trials. Trials will be identical except the following interventions:
- One hour of rest (Con)
- One hour of classical interval walking (repeated cycles of 3 min of fast and 3 min of slow walking; IW3)
- One hour of fast alternating interval walking (repeated cycles of 1 min of fast and 1 min of slow walking; IW1).
After the interventions subjects will undergo a standardized mixed meal tolerance test, with consecutive measurements of blood glucose, insulin and c-peptide.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- Center for Physical Activity Research (CFAS)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Type 2 diabetes mellitus
- Body mass index > 18 but < 40 m2/kg
- Agreement to pause antidiabetic medication from 2 days before to after each trial
Exclusion Criteria:
- Pregnancy
- Smoking
- Use of exogenous insulin
- Contraindication to increased levels of physical activity
- Evidence of thyroid, liver, lung, heart or kidney 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 |
---|---|
Experimental: Control (Con)
No exercise intervention.
|
One hour of rest.
Other Names:
|
Experimental: Interval Walking - 3 min intervals (IW3)
One hour of classical interval walking exercise (repeated cycles of 3 min of fast and 3 min of slow walking.
|
A one hour exercise bout with repeated cycles of 3 min of fast and 3 min of slow walking
Other Names:
|
Experimental: Interval Walking - 1 min intervals (IW1)
One hour of fast alternating interval walking exercise (repeated cycles of 3 min of fast and 3 min of slow walking
|
A one hour exercise bout with repeated cycles of 1 min of fast and 1 min of slow walking
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycemic control
Time Frame: Within the first 4 hours after the interventions
|
Glycemic control will be measured after each intervention.
Subjects will receive a standardized mixed meal tolerance test (MMTT), and blood glucose values will be obtained during the test.
|
Within the first 4 hours after the interventions
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin secretion
Time Frame: Within the first 4 hours after the interventions
|
Insulin and C-peptide will be measured during the MMTT
|
Within the first 4 hours after the interventions
|
Insulin sensitivity
Time Frame: Within the first 4 hours after the interventions
|
From the measurements og glucose and insulin during the MMTT, various indices of insulin sensitivity will be assessed
|
Within the first 4 hours after the interventions
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kristian Karstoft, MD, PhD, Centre for Physical Activity Research, Rigshospitalet, 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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-1-2014-060
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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