Diabetes Mellitus, Type 2NCT02998008
Effects of Acute High Intensity Exercise Training on Cardiac Function in Type II Diabetes
A study testing high intensity interval training in people with Diabetes Mellitus, Type 2, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
It is known from research that long-term exercise exposure in type 2 diabetes had positive effects. However, the effect of acute exercise in a patient group with already reduced cardiac function is not known. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- 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
- 14 participants
- Where
- 1 siteNorway
- Study dates
- 2 Jan 2017to Mar 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type II diabetes
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
It is known from research that long-term exercise exposure in type 2 diabetes had positive effects. However, the effect of acute exercise in a patient group with already reduced cardiac function is not known.
In this study, the impact of acute exhaustive high intensity interval training on cardiac function will be investigated in type 2 diabetes patients.
One single session of exhaustive high intensity interval exercise training is expected to lead to a greater cardiac stress in diabetics than in non-diabetics, and in addition the right ventricle of the heart is expected to be more affected than the left ventricle.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- high intensity interval training
- Keywords
- Exercise Therapy, Heart Function Tests, Heart/physiology, Echocardiography
- 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.
high intensity interval trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Diabetes type 2 patients | Other | diabetes type 2 patients whose cardiac function is tested after 4x4 high intensity interval training Receives: Behavioral: high intensity interval training |
| Healthy volunteers | Other | healthy volunteers whose cardiac function is tested after 4x4 high intensity interval training Receives: Behavioral: high intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
echocardiography
peak longitudinal systolic tricuspid annular velocity in cm/s
Measured: 30 minutes each measurement per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start2 Jan 2017
- Primary completionMar 2018
- Study completionMar 2018
Why it stopped: due to difficulties to attract participants
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.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Helse Nord-Trøndelag HF
- Responsible party
- Sponsor
- Investigators
- Øystein Risa, phd, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998008
- Sponsor's protocol ID
- 2016/1596
- Status last verified
- Nov 2018
- First submitted
- 16 Dec 2016
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ness HO, Ljones K, Gjelsvik RH, Tjonna AE, Malmo V, Nilsen HO, Hollekim-Strand SM, Dalen H, Hoydal MA. Acute effects of high intensity training on cardiac function: a pilot study comparing subjects with type 2 diabetes to healthy controls. Sci Rep. 2022 May 17;12(1):8239. doi: 10.1038/s41598-022-12375-2.
PubMed 35581305
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute High Intensity Exercise Training on Cardiac Function in Type II Diabetes
- ClinicalTrials.gov ID
- NCT02998008
- Acronym / sponsor ID
- 2016/1596
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Exercise Therapy, Heart Function Tests, Heart/physiology, Echocardiography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to difficulties to attract participants
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Helse Nord-Trøndelag HF
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 20 Dec 2016 (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.
It is known from research that long-term exercise exposure in type 2 diabetes had positive effects. However, the effect of acute exercise in a patient group with already reduced cardiac function is not known.
In this study, the impact of acute exhaustive high intensity interval training on cardiac function will be investigated in type 2 diabetes patients.
One single session of exhaustive high intensity interval exercise training is expected to lead to a greater cardiac stress in diabetics than in non-diabetics, and in addition the right ventricle of the heart is expected to be more affected than the left ventricle.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes type 2 patients | Other | Behavioral: high intensity interval trainingdiabetes type 2 patients whose cardiac function is tested after 4x4 high intensity interval training |
| Healthy volunteers | Other | Behavioral: high intensity interval traininghealthy volunteers whose cardiac function is tested after 4x4 high intensity interval training |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Type II diabetes
Key exclusion criteria (1 listed)
- -
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 training | Behavioural | Diabetes type 2 patients, Healthy volunteers |
Primary outcome
echocardiography
Time frame: 30 minutes each measurement per subject
peak longitudinal systolic tricuspid annular velocity in cm/s
Results and safety
The study was stopped early (reason given: due to difficulties to attract participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Derived from this study: PubMed 35581305Ness HO, Ljones K, Gjelsvik RH, Tjonna AE, Malmo V, Nilsen HO, Hollekim-Strand SM, Dalen H, Hoydal MA. Acute effects of high intensity training on cardiac function: a pilot study comparing subjects with type 2 diabetes to healthy controls. Sci Rep. 2022 May 17;12(1):8239. doi: 10.1038/s41598-022-12375-2.
- 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.
Øystein Risa, phd study director
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 high intensity 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 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: stopped early, as of the sponsor's last update on 16 Nov 2018. 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 was stopped early (reason given: due to difficulties to attract participants). Results are not available in the source record.
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?
echocardiography (time frame: 30 minutes each measurement per subject). 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 NCT02998008, 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 16 Nov 2018; AzTrials last refreshed its copy on 3 Nov 2026.