Type 2 DiabetesHIT_T2DMNCT01732705
High Intensity Interval Training (HIT) in Patients With Type 2 Diabetes
A study testing High intensity interval training in people with Type 2 Diabetes, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to determine the effect of High Intensity Interval Training (HIT) on insulin sensitivity in skeletal muscle in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- High intensity interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2012to Dec 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 40 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 10 subjects with Type 2 diabetes. 10 healthy control subjects.
- BMI 28-35
- diet or tablet treatment for diabetes
Who cannot join
- regular physical activity
- diseases other than type 2 diabetes
- insulin treatment
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Xlab, Department of Biomedical Sciences, University of Copenhagen
Copenhagen, 2200
About this study
Official title: Effect of High Intensity Interval Training (HIT) on Insulin Sensitivity in Patients With Type 2 Diabetes
The purpose of this study is to determine the effect of High Intensity Interval Training (HIT) on insulin sensitivity in skeletal muscle in patients with type 2 diabetes.
Read the detailed description
Physical exercise increases insulin sensitivity in skeletal muscle in healthy as well as in individuals with type 2 diabetes, but implies a considerable time commitment. High intensity interval training (HIT) is time-efficient exercise consisting of repeated bouts of short duration high intensive workloads. The aim of this study is to determine the effect of HIT in patients with type 2 diabetes, and to clarify the mechanisms of a possible positive effect of HIT.
Exercise is performed as 2 weeks one-legged training on an ergometer bicycle. Thus one leg serves as a control leg. Insulin sensitivity in trained and non-trained muscle will be measured after completion of the overall training program by euglycemic hyperinsulinemic clamp method and a-v catheterization of both legs. Muscle biopsies will be obtained during training period for measuring of muscle glycogen content, and muscle biopsies for further analysis obtained during the experimental day.
- Conditions
- Type 2 Diabetes
- Being tested
- High intensity interval training
- Keywords
- Type 2 diabetes, Insulin sensitivity, High intensity interval training
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval trainingBehavioural
Also called High intense interval training, HIT, HIIT
HIT will be conducted as 2 weeks of one legged high intense interval training (8 sessions every 2nd day). Each training session will consist of 10 x 1 min intervals on ergometer bicycle interspersed with 1 min recovery.
| Study group | Role | What they receive |
|---|---|---|
| HIT (trained leg) DM | Experimental | High intensity interval training for one leg (trained leg) (randomized) in patient with type 2 diabetes Receives: Behavioral: High intensity interval training |
| Control leg, DM | No intervention | Control leg (untrained leg)in patient with type 2 diabetes |
| HIT (trained leg), Control subject | Experimental | High intensity interval training for one leg (trained leg) (randomized) in control subject Receives: Behavioral: High intensity interval training |
| Control leg, Control subject | No intervention | Control leg (untrained leg)in control subject |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Insulin sensitivity in trained and non-trained muscle will be measured by euglycemic hyperinsulinemic clamp method and a-v catheterization of both legs.
Measured: 2 days after last training session (day 17)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2014
- Study completionDec 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 DiabetesStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark
- Responsible party
- Principal investigator, Flemming Dela, University of Copenhagen
- Investigators
- Flemming Dela, MD. Prof., Principal investigator, Xlab, Department of Biomedical Sciences, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732705
- Sponsor's protocol ID
- HIT-T2DM
- Acronym
- HIT_T2DM
- Status last verified
- Feb 2021
- First submitted
- 12 Oct 2012
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Dela F, Ingersen A, Andersen NB, Nielsen MB, Petersen HHH, Hansen CN, Larsen S, Wojtaszewski J, Helge JW. Effects of one-legged high-intensity interval training on insulin-mediated skeletal muscle glucose homeostasis in patients with type 2 diabetes. Acta Physiol (Oxf). 2019 Jun;226(2):e13245. doi: 10.1111/apha.13245. Epub 2019 Feb 14.
PubMed 30585698
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Intensity Interval Training (HIT) on Insulin Sensitivity in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01732705
- Acronym / sponsor ID
- HIT_T2DM / HIT-T2DM
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Insulin sensitivity, High intensity interval training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark
- Study start
- Sep 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Nov 2012 (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.
The purpose of this study is to determine the effect of High Intensity Interval Training (HIT) on insulin sensitivity in skeletal muscle in patients with type 2 diabetes.
Detailed description
Physical exercise increases insulin sensitivity in skeletal muscle in healthy as well as in individuals with type 2 diabetes, but implies a considerable time commitment. High intensity interval training (HIT) is time-efficient exercise consisting of repeated bouts of short duration high intensive workloads. The aim of this study is to determine the effect of HIT in patients with type 2 diabetes, and to clarify the mechanisms of a possible positive effect of HIT.
Exercise is performed as 2 weeks one-legged training on an ergometer bicycle. Thus one leg serves as a control leg. Insulin sensitivity in trained and non-trained muscle will be measured after completion of the overall training program by euglycemic hyperinsulinemic clamp method and a-v catheterization of both legs. Muscle biopsies will be obtained during training period for measuring of muscle glycogen content, and muscle biopsies for further analysis obtained during the experimental day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIT (trained leg) DM | Experimental | Behavioral: High intensity interval trainingHigh intensity interval training for one leg (trained leg) (randomized) in patient with type 2 diabetes |
| Control leg, DM | No intervention | –Control leg (untrained leg)in patient with type 2 diabetes |
| HIT (trained leg), Control subject | Experimental | Behavioral: High intensity interval trainingHigh intensity interval training for one leg (trained leg) (randomized) in control subject |
| Control leg, Control subject | No intervention | –Control leg (untrained leg)in control subject |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 10 subjects with Type 2 diabetes. 10 healthy control subjects.
- BMI 28-35
- diet or tablet treatment for diabetes
Key exclusion criteria (3 listed)
- regular physical activity
- diseases other than type 2 diabetes
- insulin treatment
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 trainingAlso: High intense interval training, HIT, HIITHIT will be conducted as 2 weeks of one legged high intense interval training (8 sessions every 2nd day). Each training session will consist of 10 x 1 min intervals on ergometer bicycle interspersed with 1 min recovery. | Behavioural | HIT (trained leg) DM, HIT (trained leg), Control subject |
Primary outcome
Insulin sensitivity
Time frame: 2 days after last training session (day 17)
Insulin sensitivity in trained and non-trained muscle will be measured by euglycemic hyperinsulinemic clamp method and a-v catheterization of both legs.
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 9 Feb 2021.
- Derived from this study: PubMed 30585698Dela F, Ingersen A, Andersen NB, Nielsen MB, Petersen HHH, Hansen CN, Larsen S, Wojtaszewski J, Helge JW. Effects of one-legged high-intensity interval training on insulin-mediated skeletal muscle glucose homeostasis in patients with type 2 diabetes. Acta Physiol (Oxf). 2019 Jun;226(2):e13245. doi: 10.1111/apha.13245. Epub 2019 Feb 14.
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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.
Flemming Dela, MD. Prof. principal investigator
Xlab, Department of Biomedical Sciences, University of Copenhagen
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 in people with Type 2 Diabetes, run by University of Copenhagen 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 3 inclusion and 3 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 9 Feb 2021. 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?
Insulin sensitivity (time frame: 2 days after last training session (day 17)). 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 NCT01732705, 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 9 Feb 2021.