Type 2 Diabetes Mellitusacute IWSNCT01987258
The Acute Effect of Interval-walking
A study testing Interval Walking and Continuous walking in people with Type 2 Diabetes Mellitus, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Interval Walking and Continuous walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2013to Feb 2014
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus, type 2
Who cannot join
- Smoking
- Pregnancy
- insulin dependence
- Contraindication to physical activity (as judged by medical history and screening)
- Evidence of thyroid, liver, lung, kidney or heart disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Centre of Inflammation and Metabolism (CIM), Rigshospitalet, Tagensvej 20, section M7641
Copenhagen, 2100
About this study
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Interval Walking, Continuous walking
- Keywords
- Glycemic control, excess post-exercise oxygen consumption
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interval WalkingBehavioural
Also called Interval exercise, Interval training
Continuous walkingBehavioural
Also called Continuous exercise, Continuous training
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No exercise (control experiment) |
| Interval Walking | Experimental | A one hour interval walking exercise bout Receives: Behavioral: Interval Walking |
| Continuous walking | Experimental | A one hour continuous walking exercise bout Receives: Behavioral: Continuous walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
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.
Measured: 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 outcomes (1)
Excess post-exercise oxygen consumption (EPOC)
EPOC will be assessed during the hours following the before-mentioned specific exercise bouts using the indirect calorimetry ventilated hood technique.
Measured: Will be assessed immediately after the intervention using a ventilated hood (duration: 5 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inge Holm, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kristian Karstoft, MD, Principal investigator, Centre of Inflammation and Metabolism (CIM), Rigshospitalet, Tagensvej 20, section M7641, DK-2100 Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987258
- Sponsor's protocol ID
- H-3-2012-141
- Acronym
- acute IWS
- Status last verified
- Feb 2014
- First submitted
- 28 Jun 2013
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Karstoft K, Christensen CS, Pedersen BK, Solomon TP. The acute effects of interval- Vs continuous-walking exercise on glycemic control in subjects with type 2 diabetes: a crossover, controlled study. J Clin Endocrinol Metab. 2014 Sep;99(9):3334-42. doi: 10.1210/jc.2014-1837. Epub 2014 Jun 6.
PubMed 24905068
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Interval-walking
- ClinicalTrials.gov ID
- NCT01987258
- Acronym / sponsor ID
- acute IWS / H-3-2012-141
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Glycemic control, excess post-exercise oxygen consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 19 Nov 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No exercise (control experiment) |
| Interval Walking | Experimental | Behavioral: Interval WalkingA one hour interval walking exercise bout |
| Continuous walking | Experimental | Behavioral: Continuous walkingA one hour continuous walking exercise bout |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetes mellitus, type 2
Key exclusion criteria (5 listed)
- Smoking
- Pregnancy
- insulin dependence
- Contraindication to physical activity (as judged by medical history and screening)
- Evidence of thyroid, liver, lung, kidney or heart disease
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 |
|---|---|---|
| Interval WalkingAlso: Interval exercise, Interval training | Behavioural | Interval Walking |
| Continuous walkingAlso: Continuous exercise, Continuous training | Behavioural | Continuous walking |
Primary outcome
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.
1 secondary outcome
Excess post-exercise oxygen consumption (EPOC)
Time frame: Will be assessed immediately after the intervention using a ventilated hood (duration: 5 hours).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
- Derived from this study: PubMed 24905068Karstoft K, Christensen CS, Pedersen BK, Solomon TP. The acute effects of interval- Vs continuous-walking exercise on glycemic control in subjects with type 2 diabetes: a crossover, controlled study. J Clin Endocrinol Metab. 2014 Sep;99(9):3334-42. doi: 10.1210/jc.2014-1837. Epub 2014 Jun 6.
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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.
Kristian Karstoft, MD principal investigator
Centre of Inflammation and Metabolism (CIM), Rigshospitalet, Tagensvej 20, section M7641, DK-2100 Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interval Walking and Continuous walking in people with Type 2 Diabetes Mellitus, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 27 Feb 2014. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01987258, which also lists 1 linked publication.
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 27 Feb 2014.