Diabetes Mellitus, Type 2NCT02388113
Effect of Exercise Frequency on Metabolic Control and Heart Function in Type 2 Diabetes
A study testing accumulated exercise and traditional exercise in people with Diabetes Mellitus, Type 2, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
This study will compare two interventions with the same exercise intensities and caloric expenditure but with different exercise frequency, on metabolic control and other risk factors in individuals with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- accumulated exercise and traditional exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2014to Nov 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes
Who cannot join
- insulin treatment
- severe chronic diabetic complications
- liver dysfunction
- kidney dysfunction
- inflammatory diseases
- heart failure
Show all 10Show fewer
- myocardial ischemia
- major cardiovascular event history
- physical exercise more than current guidelines for type 2 diabetes
- inability to exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Accumulated Versus Traditional Exercise Training on Metabolic Control and Heart Function in Individuals With Type 2 Diabetes
This study will compare two interventions with the same exercise intensities and caloric expenditure but with different exercise frequency, on metabolic control and other risk factors in individuals with type 2 diabetes.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- accumulated exercise, traditional exercise
- Keywords
- Exercise therapy, Time factors
- 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.
accumulated exerciseBehavioural
traditional exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| accumulated exercise | Experimental | 12 exercise sessions of 10 minutes each week, 2 per day, 1 day rest Receives: Behavioral: accumulated exercise |
| traditional exercise | Active comparator | 4 exercise sessions of 30 minutes each week, 3 in the training laboratory, 1 at home. Receives: Behavioral: traditional exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycosylated hemoglobin (HbA1c)
The measured HbA1c level consists of average blood glucose by 50% from the last month, 25% from the previous month, and 25% by the two first previous months. Analysis: standard procedure of St Olavs Hospital.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte Ingul, PhD MD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388113
- Sponsor's protocol ID
- 2014/1405
- Status last verified
- Nov 2015
- First submitted
- 9 Mar 2015
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Accumulated Versus Traditional Exercise Training on Metabolic Control and Heart Function in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02388113
- Acronym / sponsor ID
- 2014/1405
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Exercise therapy, Time factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 13 Mar 2015 (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.
This study will compare two interventions with the same exercise intensities and caloric expenditure but with different exercise frequency, on metabolic control and other risk factors in individuals with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| accumulated exercise | Experimental | Behavioral: accumulated exercise12 exercise sessions of 10 minutes each week, 2 per day, 1 day rest |
| traditional exercise | Active comparator | Behavioral: traditional exercise4 exercise sessions of 30 minutes each week, 3 in the training laboratory, 1 at home. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- type 2 diabetes
Key exclusion criteria (10 listed)
- insulin treatment
- severe chronic diabetic complications
- liver dysfunction
- kidney dysfunction
- inflammatory diseases
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 |
|---|---|---|
| accumulated exercise | Behavioural | accumulated exercise |
| traditional exercise | Behavioural | traditional exercise |
Primary outcome
glycosylated hemoglobin (HbA1c)
Time frame: 12 weeks
The measured HbA1c level consists of average blood glucose by 50% from the last month, 25% from the previous month, and 25% by the two first previous months. Analysis: standard procedure of St Olavs Hospital.
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 6 Nov 2015.
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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.
Charlotte Ingul, PhD MD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing accumulated exercise and traditional exercise in people with Diabetes Mellitus, Type 2, run by Norwegian University of Science and Technology at 1 site in Norway.
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 10 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 6 Nov 2015. 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 Norway. 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?
glycosylated hemoglobin (HbA1c) (time frame: 12 weeks). 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 6 Nov 2015.