Type 2 DiabetesHITNCT02039934
Effect of High-intensity Low-volume Training on Insulin Sensitivity in Type 2 Diabetes
A study testing High intensity interval training in people with Type 2 Diabetes, run by German Diabetes Center at 1 site in Germany.
Trial summary
High intensity interval training is applied for several diseases. Hypothesis: High intensity interval training improves insulin sensitivity in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- High intensity interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2014to Aug 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women
- Age: 30 - 65 years
- Typ-2-Diabetes (BMI > 25 kg/m²)
- Increased risk for diabetes (BMI >25 kg/m²)
Who cannot join
- Acute Infection within the last 2 weeks prior to the intervention
- Autoimmune diseases and immune suppressive diseases (Leukocytes < 5000/μl)
- Intake of immunomodulating drugs (Glucocorticoids, Antihistamine, ASS)
- Pregnancy, Breastfeeding, Menstruation
- Kidney insufficiency (Creatinine > 1,5 mg/dl)
- Cardiovascular diseases
Show all 23Show fewer
- Anemia (Hb < 12g/l), disorders of wound healing or blood clotting
- Participation in another study within the last 2 months before the investigation
- Metallic or magnetic items on or in the body
- Claustrophobia
- Thyroid dysfunction
- Intake of glitazones or insulin therapy
- Smoking (Non-smoking since > 1 year), alcohol consumption (Men > 30 g/d, Women > 20g/d) or illegal drugs
- Psychiatric disorders
- Risk for/or manifest AIDS (HIV) or Hepatitis B or C
- Night shift working
- Hypersensitivity to local anesthetics
- Cancer disease
- Lung diseases
- Systematic endurance training (>1x per week > 60min.)
- Maximal oxygen consumption (VO2 max) <20ml/min/kg
- Orthopedic disorders
- Musculoskeletal diseases
Trial locations and contacts
1 site in 1 country.
Germany1 site
German Diabetes Center
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: Effect of High-intensity Low-volume Training on Insulin Sensitivity in Patients With Type 2 Diabetes and Healthy Lean Subjects
High intensity interval training is applied for several diseases.
Hypothesis: High intensity interval training improves insulin sensitivity in patients with type 2 diabetes.
Read the detailed description
Type 2 diabetes mellitus is a multifactorial metabolic disease that is characterized by reduced insulin sensitivity and insulin production leading to impaired glucose tolerance. Overweight and low physical activity are the main risk factors for the development of type 2 diabetes. Increased physical activity has shown to improve insulin sensitivity, hence, exercise plays a significant role in the prevention and therapy of type 2 diabetes. This study aims at investigating the acute and chronic effects of high-intensity low-volume training, that consists of brief bursts of very vigorous exercise separated by recovery periods, on metabolic function in patients with type 2 diabetes, people at high risk for the disease and healthy, lean individuals. Study participants take part in 30 min training session three times a week for a period of 12 weeks. Participants are studied on four occasions, prior to the intervention, after an acute bout of exercise as well as after 6 and 12 weeks of training in order to assess physical fitness, body composition, insulin sensitivity, energy metabolism in muscle, adipose tissue inflammation and neurological function. It is hypothesized that this type of exercise leads to significant improvements in insulin action and oxidative phosphorylation in muscle
- Conditions
- Type 2 Diabetes
- Being tested
- High intensity interval training
- Keywords
- type 2 diabetes, exercise intervention, high intensity interval training
- 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 trainingOther
The intervention consists of 30 minute sessions of high-intensity interval training on a bicycle ergometer three times per week.
Training program: After 5 minutes of warm-up the subject cycles for 10 intervals of 60 s. at 90 % maximum effort separated 60 s at 20% maximum effort, based on a previously performed spiroergometry, followed by 5 minutes of cool-down.
| Study group | Role | What they receive |
|---|---|---|
| high intensity interval training | Experimental | 30 minute sessions of high-intensity interval training on a bicycle ergometer three times per week Receives: Other: High intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Insulin sensitivity by high intensity interval training
High intensity interval training leads to significant improvements in insulin action and oxidative phosphorylation in skeletal muscle.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2018
- Study completionAug 2018
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Diabetes Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Roden, Prof., MD, Study director, German Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039934
- Sponsor's protocol ID
- HIT and insulin sensitivity
- Acronym
- HIT
- Status last verified
- Aug 2023
- First submitted
- 7 Sep 2012
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Apostolopoulou M, Mastrototaro L, Hartwig S, Pesta D, Strassburger K, de Filippo E, Jelenik T, Karusheva Y, Gancheva S, Markgraf D, Herder C, Nair KS, Reichert AS, Lehr S, Mussig K, Al-Hasani H, Szendroedi J, Roden M. Metabolic responsiveness to training depends on insulin sensitivity and protein content of exosomes in insulin-resistant males. Sci Adv. 2021 Oct 8;7(41):eabi9551. doi: 10.1126/sciadv.abi9551. Epub 2021 Oct 8.
PubMed 34623918
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-intensity Low-volume Training on Insulin Sensitivity in Patients With Type 2 Diabetes and Healthy Lean Subjects
- ClinicalTrials.gov ID
- NCT02039934
- Acronym / sponsor ID
- HIT / HIT and insulin sensitivity
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, exercise intervention, high intensity interval training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- German Diabetes CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 20 Jan 2014 (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.
High intensity interval training is applied for several diseases.
Hypothesis: High intensity interval training improves insulin sensitivity in patients with type 2 diabetes.
Detailed description
Type 2 diabetes mellitus is a multifactorial metabolic disease that is characterized by reduced insulin sensitivity and insulin production leading to impaired glucose tolerance. Overweight and low physical activity are the main risk factors for the development of type 2 diabetes. Increased physical activity has shown to improve insulin sensitivity, hence, exercise plays a significant role in the prevention and therapy of type 2 diabetes. This study aims at investigating the acute and chronic effects of high-intensity low-volume training, that consists of brief bursts of very vigorous exercise separated by recovery periods, on metabolic function in patients with type 2 diabetes, people at high risk for the disease and healthy, lean individuals. Study participants take part in 30 min training session three times a week for a period of 12 weeks. Participants are studied on four occasions, prior to the intervention, after an acute bout of exercise as well as after 6 and 12 weeks of training in order to assess physical fitness, body composition, insulin sensitivity, energy metabolism in muscle, adipose tissue inflammation and neurological function. It is hypothesized that this type of exercise leads to significant improvements in insulin action and oxidative phosphorylation in muscle
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| high intensity interval training | Experimental | Other: High intensity interval training30 minute sessions of high-intensity interval training on a bicycle ergometer three times per week |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women
- Age: 30 - 65 years
- Typ-2-Diabetes (BMI > 25 kg/m²)
- Increased risk for diabetes (BMI >25 kg/m²)
Key exclusion criteria (23 listed)
- Acute Infection within the last 2 weeks prior to the intervention
- Autoimmune diseases and immune suppressive diseases (Leukocytes < 5000/μl)
- Intake of immunomodulating drugs (Glucocorticoids, Antihistamine, ASS)
- Pregnancy, Breastfeeding, Menstruation
- Kidney insufficiency (Creatinine > 1,5 mg/dl)
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 trainingThe intervention consists of 30 minute sessions of high-intensity interval training on a bicycle ergometer three times per week. Training program: After 5 minutes of warm-up the subject cycles for 10 intervals of 60 s. at 90 % maximum effort separated 60 s at 20% maximum effort, based on a previously performed spiroergometry, followed by 5 minutes of cool-down. | Other | high intensity interval training |
Primary outcome
Improvement of Insulin sensitivity by high intensity interval training
Time frame: 2 years
High intensity interval training leads to significant improvements in insulin action and oxidative phosphorylation in skeletal muscle.
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 Aug 2023.
- Results publication: PubMed 34623918Apostolopoulou M, Mastrototaro L, Hartwig S, Pesta D, Strassburger K, de Filippo E, Jelenik T, Karusheva Y, Gancheva S, Markgraf D, Herder C, Nair KS, Reichert AS, Lehr S, Mussig K, Al-Hasani H, Szendroedi J, Roden M. Metabolic responsiveness to training depends on insulin sensitivity and protein content of exosomes in insulin-resistant males. Sci Adv. 2021 Oct 8;7(41):eabi9551. doi: 10.1126/sciadv.abi9551. Epub 2021 Oct 8.
- HomepageLink provided by the sponsor.
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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.
Michael Roden, Prof., MD study director
German Diabetes Center
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 German Diabetes Center at 1 site in Germany.
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 4 inclusion and 23 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 Aug 2023. 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 Germany. 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?
Improvement of Insulin sensitivity by high intensity interval training (time frame: 2 years). 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 NCT02039934, 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 Aug 2023.