Diabetes Mellitus, Type 2NCT03349944
Effect of Training Intensity on Health Outcomes in Diabetes
A study testing Training in people with Diabetes Mellitus, Type 2, run by Morten Hostrup, PhD at 1 site in Denmark.
Trial summary
The project will investigate high intensity interval training on the glucose regulation in type 2 diabetic subjects compared to moderate continuous exercise. Read more about this study
- Who is it for?
- Ages 30 to 70 years, men only
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2017to 8 Jan 2019
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes Age: 30-70 Non smokers (minimum the last 15 years) Inactive lifestyle (<2 hours pr. week) BMI <35 kg/m2
Who cannot join
- Smoking Prior cardiavascular diseases Alcohol intake 14> units pr. week.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of High Intensity Interval Training on Nuclear Orphan Receptor Expression and Adrenergic Signaling in Skeletal Muscle of Persons With Type 2 Diabetes.
The project will investigate high intensity interval training on the glucose regulation in type 2 diabetic subjects compared to moderate continuous exercise.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Training
- Keywords
- exercise
- 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.
TrainingBehavioural
The duration of the training intervention is 10 weeks of either moderate exercise og high intensity interval training.
| Study group | Role | What they receive |
|---|---|---|
| Moderate intensity training | Active comparator | Moderate continuous exercise three times pr. week for 50 min. Receives: Behavioral: Training |
| High intensity training | Experimental | High intensity interval training three times pr. week for 15 min. Receives: Behavioral: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Long term blood glucose levels
Measured: From baseline measure to post test: 10 weeks
Secondary outcomes (1)
Oral glucose tolerance test
75gr glucose is ingested, bllod sampling over the following two hours
Measured: From baseline measure to post test: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start1 Aug 2017
- Primary completion21 Dec 2018
- Study completion8 Jan 2019
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morten Hostrup, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Morten Hostrup, PhD, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349944
- Sponsor's protocol ID
- NOR
- Status last verified
- Apr 2019
- First submitted
- 17 Nov 2017
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Baasch-Skytte T, Gunnarsson TP, Fiorenza M, Bangsbo J. Skeletal muscle proteins important for work capacity are altered with type 2 diabetes - Effect of 10-20-30 training. Physiol Rep. 2021 Jan;9(1):e14681. doi: 10.14814/phy2.14681.
PubMed 33426802
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Intensity Interval Training on Nuclear Orphan Receptor Expression and Adrenergic Signaling in Skeletal Muscle of Persons With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT03349944
- Acronym / sponsor ID
- NOR
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Morten Hostrup, PhDUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 22 Nov 2017 (actual)
- 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 project will investigate high intensity interval training on the glucose regulation in type 2 diabetic subjects compared to moderate continuous exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate intensity training | Active comparator | Behavioral: TrainingModerate continuous exercise three times pr. week for 50 min. |
| High intensity training | Experimental | Behavioral: TrainingHigh intensity interval training three times pr. week for 15 min. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetes Age: 30-70 Non smokers (minimum the last 15 years) Inactive lifestyle (<2 hours pr. week) BMI <35 kg/m2
Key exclusion criteria (1 listed)
- Smoking Prior cardiavascular diseases Alcohol intake 14> units pr. week.
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 |
|---|---|---|
| TrainingThe duration of the training intervention is 10 weeks of either moderate exercise og high intensity interval training. | Behavioural | High intensity training, Moderate intensity training |
Primary outcome
HbA1c
Time frame: From baseline measure to post test: 10 weeks
Long term blood glucose levels
1 secondary outcome
Oral glucose tolerance test
Time frame: From baseline measure to post test: 10 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 12 Apr 2019.
- Derived from this study: PubMed 33426802Baasch-Skytte T, Gunnarsson TP, Fiorenza M, Bangsbo J. Skeletal muscle proteins important for work capacity are altered with type 2 diabetes - Effect of 10-20-30 training. Physiol Rep. 2021 Jan;9(1):e14681. doi: 10.14814/phy2.14681.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Diabetes Mellitus, Type 2, run by Morten Hostrup, PhD 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 1 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 12 Apr 2019. 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?
HbA1c (time frame: From baseline measure to post test: 10 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 NCT03349944, 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 12 Apr 2019.