Diabetes Mellitus, Type 2NCT02340260
Time Efficient Exercise in Type 2 Diabetes
A study testing High intensity interval training and Sprint interval training in people with Diabetes Mellitus, Type 2, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Exercise is considered a cornerstone in the prevention and treatment of type 2 diabetes, but few patients exercise according to guidelines. In this study the effect of two time efficient high intensity exercise protocols on glycemic control and other cardiometabolic risk factors are investigated in patients with type… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- High intensity interval training and Sprint interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2013to Jan 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 20-65 years
- diagnosed with type 2 diabetes within the past 10 years
- no use of insulin.
Who cannot join
- known cardiovascular disease- or lung disease, coronary artery disease
- untreated hypertension of ≥140/90 mmHg
- orthopaedic or neurological restrictions
- severe obesity (BMI ≥35)
- pregnancy
- unability to exercise
Show all 9Show fewer
- drug- or alcohol abuse
- reluctance to sign the consent form
- more reported physical active than recommended in current exercise guidelines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Time Efficient Low-volume Interval Exercise on Cardiometabolic Risk Factors in Individuals With Type 2 Diabetes
Exercise is considered a cornerstone in the prevention and treatment of type 2 diabetes, but few patients exercise according to guidelines. In this study the effect of two time efficient high intensity exercise protocols on glycemic control and other cardiometabolic risk factors are investigated in patients with type 2 diabetes.The investigators assume that glycemic control is improved more by low-volume high intensity interval training than by extremely low-volume sprint interval training.
Read the detailed description
The world prevalence of diabetes mellitus for 2010 is estimated to 6.4 % of the adult population, and an increase up to 7.7 % is expected before 2030. 90-95 % individuals with diabetes have type 2 diabetes (T2D).
The complications of T2D lead to substantially increased risk of hypertension, cardiovascular disease (CVD) and the development of heart failure. CVD is the most common cause of death in European adults with diabetes, and the risk of developing CVD is double of that observed in individuals without diabetes. Lowering HbA1c in type 2 diabetes decreases the absolute risk of developing CVD by 5-17 %, as well as decreasing all-cause mortality by 6-15 %.
Individuals with T2D are recommended to exercise moderately or vigorously for at least 150 minutes per week. However, the majority of adults fail to meet the guidelines for even the minimum amount of physical activity, and lack of time is often cited as the main reason.
This research group has previously shown that 4x4 minute high intensity aerobic interval training (AIT) yields significantly greater response on HbA1c, BMI and diastolic dysfunction in patients with T2D with duration <10years in contrast to present recommendations. AIT reduces cardiovascular risk factors more than moderate continuous training in patients with heart failure and metabolic syndrome. In metabolic syndrome, AIT is superior in enhancing endothelial function, insulin signaling in fat and skeletal muscle and in reducing blood glucose. This shows that AIT is a time-efficient and highly effective form of exercise for both patients with T2D and other patient groups.
Recently, even lower training volumes than made use of in the projects presented above, have shown indications of improving glycaemic control in T2D. Only two weeks with a total of six sessions of high intensity training reduces blood glucose significantly in individuals with T2D. Even shorter intervals of all-out activity (2-7 bouts of 20-30 seconds of supramaximal ergometer cycling) was shown to improve both aerobic capacity and a number of metabolic and cardiovascular risk factors after few weeks of training.
However, low-volume high-intensity exercise studies are limited for T2D. The present study aims to compare the effect of two time saving, high intensity exercise protocols on cardiovascular risk factors in patients with type 2 diabetes. The investigators assume that glycemic control is improved more by low-volume high intensity interval training than by extremely low-volume sprint interval training.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- High intensity interval training, Sprint interval training
- Keywords
- Exercise, Risk factors, Exercise therapy, Hemoglobin A, Glycosylated
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval trainingBehavioural
High intensity exercise during 12 weeks with three weekly training sessions
Sprint interval trainingBehavioural
Sprint interval exercise during 12 weeks with three weekly training sessions
| Study group | Role | What they receive |
|---|---|---|
| High intensity interval training | Other | High intensity interval training starts with warming up for 3 minutes at 70 % of maximum heart rate before treadmill training 10x1-minute intervals at 90 % of HRmax, with 75 seconds of active recovery at 70 % of HRmax between each interval. Exercise is completed with a three minute cool down. All training sessions are supervised by an exercise physiologist. Treadmill inclination and/or speed will be adjusted to make sure prescribed intensity is met throughout the intervention. Receives: Behavioral: High intensity interval training |
| Sprint interval training | Other | Sprint interval training starts with warming up for 3 minutes at 70 % of maximum heart rate before treadmill training 2x20 seconds of maximum intensity intervals, with 3 minutes and 20 seconds of active recovery at 70 % of HRmax between each interval, followed by 3 minutes cooling down at the same intensity. All training sessions are supervised by an exercise physiologist. Treadmill inclination and/or speed will be adjusted to make sure prescribed intensity is met throughout the intervention. Receives: Behavioral: Sprint interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated hemoglobin (HbA1c)
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 posted16 Jan 2015 (estimated)
- Study startAug 2013
- Primary completionJan 2014
- Study completionJan 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 Diabetes Mellitus, Type 2Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Toril A Nagelhus Hernes, prof, Study director, Department Circulation and Medical Imaging, NTNU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340260
- Sponsor's protocol ID
- 2013/801
- Status last verified
- Jun 2016
- First submitted
- 7 Jan 2015
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Revdal A, Hollekim-Strand SM, Ingul CB. Can Time Efficient Exercise Improve Cardiometabolic Risk Factors in Type 2 Diabetes? A Pilot Study. J Sports Sci Med. 2016 May 23;15(2):308-13. eCollection 2016 Jun.
PubMed 27274669
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Time Efficient Low-volume Interval Exercise on Cardiometabolic Risk Factors in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02340260
- Acronym / sponsor ID
- 2013/801
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Exercise, Risk factors, Exercise therapy, Hemoglobin A, Glycosylated
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 16 Jan 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.
Exercise is considered a cornerstone in the prevention and treatment of type 2 diabetes, but few patients exercise according to guidelines. In this study the effect of two time efficient high intensity exercise protocols on glycemic control and other cardiometabolic risk factors are investigated in patients with type 2 diabetes.The investigators assume that glycemic control is improved more by low-volume high intensity interval training than by extremely low-volume sprint interval training.
Detailed description
The world prevalence of diabetes mellitus for 2010 is estimated to 6.4 % of the adult population, and an increase up to 7.7 % is expected before 2030. 90-95 % individuals with diabetes have type 2 diabetes (T2D).
The complications of T2D lead to substantially increased risk of hypertension, cardiovascular disease (CVD) and the development of heart failure. CVD is the most common cause of death in European adults with diabetes, and the risk of developing CVD is double of that observed in individuals without diabetes. Lowering HbA1c in type 2 diabetes decreases the absolute risk of developing CVD by 5-17 %, as well as decreasing all-cause mortality by 6-15 %.
Individuals with T2D are recommended to exercise moderately or vigorously for at least 150 minutes per week. However, the majority of adults fail to meet the guidelines for even the minimum amount of physical activity, and lack of time is often cited as the main reason.
This research group has previously shown that 4x4 minute high intensity aerobic interval training (AIT) yields significantly greater response on HbA1c, BMI and diastolic dysfunction in patients with T2D with duration <10years in contrast to present recommendations. AIT reduces cardiovascular risk factors more than moderate continuous training in patients with heart failure and metabolic syndrome. In metabolic syndrome, AIT is superior in enhancing endothelial function, insulin signaling in fat and skeletal muscle and in reducing blood glucose. This shows that AIT is a time-efficient and highly effective form of exercise for both patients with T2D and other patient groups.
Recently, even lower training volumes than made use of in the projects presented above, have shown indications of improving glycaemic control in T2D. Only two weeks with a total of six sessions of high intensity training reduces blood glucose significantly in individuals with T2D. Even shorter intervals of all-out activity (2-7 bouts of 20-30 seconds of supramaximal ergometer cycling) was shown to improve both aerobic capacity and a number of metabolic and cardiovascular risk factors after few weeks of training.
However, low-volume high-intensity exercise studies are limited for T2D. The present study aims to compare the effect of two time saving, high intensity exercise protocols on cardiovascular risk factors in patients with type 2 diabetes. The investigators assume that glycemic control is improved more by low-volume high intensity interval training than by extremely low-volume sprint interval training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity interval training | Other | Behavioral: High intensity interval trainingHigh intensity interval training starts with warming up for 3 minutes at 70 % of maximum heart rate before treadmill training 10x1-minute intervals at 90 % of HRmax, with 75 seconds of active recovery at 70 % of HRmax between each interval. Exercise is completed with a three minute cool down. All training sessions are supervised by an exercise physiologist. Treadmill inclination and/or speed will be adjusted to make sure prescribed intensity is met throughout the intervention. |
| Sprint interval training | Other | Behavioral: Sprint interval trainingSprint interval training starts with warming up for 3 minutes at 70 % of maximum heart rate before treadmill training 2x20 seconds of maximum intensity intervals, with 3 minutes and 20 seconds of active recovery at 70 % of HRmax between each interval, followed by 3 minutes cooling down at the same intensity. All training sessions are supervised by an exercise physiologist. Treadmill inclination and/or speed will be adjusted to make sure prescribed intensity is met throughout the intervention. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 20-65 years
- diagnosed with type 2 diabetes within the past 10 years
- no use of insulin.
Key exclusion criteria (9 listed)
- known cardiovascular disease- or lung disease, coronary artery disease
- untreated hypertension of ≥140/90 mmHg
- orthopaedic or neurological restrictions
- severe obesity (BMI ≥35)
- pregnancy
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 |
|---|---|---|
| High intensity interval trainingHigh intensity exercise during 12 weeks with three weekly training sessions | Behavioural | High intensity interval training |
| Sprint interval trainingSprint interval exercise during 12 weeks with three weekly training sessions | Behavioural | Sprint interval training |
Primary outcome
Glycosylated hemoglobin (HbA1c)
Time frame: 12 weeks
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 14 Jun 2016.
- Results publication: PubMed 27274669Revdal A, Hollekim-Strand SM, Ingul CB. Can Time Efficient Exercise Improve Cardiometabolic Risk Factors in Type 2 Diabetes? A Pilot Study. J Sports Sci Med. 2016 May 23;15(2):308-13. eCollection 2016 Jun.
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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.
Toril A Nagelhus Hernes, prof study director
Department Circulation and Medical Imaging, NTNU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity interval training and Sprint interval training 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 3 inclusion and 9 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 14 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 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?
On the ClinicalTrials.gov record for NCT02340260, 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 14 Jun 2016.