Prediabetic StateNCT03773731
High Intensity Interval Training in Prediabetes
A study testing High intensity interval training (HIIT) and Moderate intensity continuous training (MICT) in people with Prediabetic State, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This trial investigates if high intensity interval training is more effective than moderate intensity continuous training in suppressing platelet reactivity and hepatic fat content in prediabetic individuals. Read more about this study
- Who is it for?
- Ages 19 to 75 years, men only
- Conditions the study is for
- Prediabetic State
- What is being tested?
- High intensity interval training (HIIT) and Moderate intensity continuous training (MICT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteAustria
- Study dates
- 4 Jan 2019to Feb 2021
- 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 19 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- prediabetic (insulin-insensitive) patients
- either fasting plasma glucose 100- 125 mg/dl or HbA1c 5.7 - 6.4
- < 3kg bodyweight change within the last 6 months
Who cannot join
- Any contraindications for exercise
- resulting from anamnesis ( e.g. history of angina pectoris, peripheral arterial disease), ECG at rest or during graded exercise test, echocardiogram, echocardiography or lung function test
- chronical joint pain that makes exercise training on bicycle ergometers impossible
- any conditions that make the successful participation in the study unlikely
- islet cell autoantibodies
- Medication: insulin, thiazolidindiones, statins, antidepressants
- Secondary diseases: History of end-stage liver or kidney disease; pronounced neuropathy or retinopathy
- drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
MUVienna
Vienna, 1090
Stefan Heber, MD, PhD, 0043 1 40160 ext. 31425, stefan.heber@meduniwien.ac.at
About this study
Official title: Impact of High Intensity Interval Training vs. Continuous Aerobic Training on Platelet Insulin Resistance, Platelet Function and Hepatic Steatosis in Patients With Prediabetes
This trial investigates if high intensity interval training is more effective than moderate intensity continuous training in suppressing platelet reactivity and hepatic fat content in prediabetic individuals.
Read the detailed description
Background:
The prevalence of type 2 diabetes mellitus (T2DM) is rising dramatically. T2DM represents a major cause for cardiovascular disease -related mortality and morbidity and increasingly burdens healthcare systems. While the fundamental pathomechanism of T2DM is insulin resistance of muscle and adipose tissue, recent studies demonstrate that insulin resistance in T2DM also occurs in platelets. As insulin directly inhibits platelet function, this mechanism might contribute to platelet activation and platelet hyperreactivity, which were in fact detected in diabetic patients. Since (inadvertent) platelet activation is causally linked to the development of atherosclerosis and atherothrombosis, regulation of platelet function is of utmost importance. Exercise training, performed on a regular basis has been shown to reduce morbidity and mortality in sedentary and diseased populations. Furthermore, exercise training improves whole body insulin sensitivity - however, it is currently unclear, if exercise training also affects insulin sensitivity of platelets. Recently, a time-saving interval training protocol has been adapted for T2DM-patients. Since this adapted high intensity interval training (HIIT) needs a fractional time commitment of exercise training according to current guidelines, HIIT possibly represents a promising instrument to increase adherence to exercise and thereby reduce T2DM morbidity.
Aims:
The primary aim of this study is to investigate the effect of 12 weeks of HIIT vs. continuous training (CT) on platelet insulin sensitivity and platelet (hyper)reactivity in prediabetic patients.
Secondary aims are to assess the effect of HIIT and CT on whole body insulin sensitivity and fitness in prediabetic patients as well as on various parameters of platelet function and on the hepatic fat content.
Hypotheses:
Our main hypothesis is that HIIT increases platelet insulin sensitivity and thereby decreases platelet activation/reactivity in patients with prediabetes. Methods: 44 prediabetic (see inclusion criteria) patients will be enrolled in this study. Patients will randomly be assigned to a HIIT group (committed to a supervised training program) or a CT group. After initial examinations (supervised graded exercise test, platelet function tests, oral glucose tolerance test, measurement of the hepatic fat content via FibroScan®), supervised training will be performed over a period of 12 weeks. Tests performed at the beginning of the study will be repeated after the training period.
- Conditions
- Prediabetic State
- Being tested
- High intensity interval training (HIIT), Moderate intensity continuous training (MICT)
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval training (HIIT)Behavioural
Exercise training on bicycle ergometer with high intensity bouts of 1 min interspersed by low intensity recovery intervals
Moderate intensity continuous training (MICT)Behavioural
Exercise training on bicycle ergometer with moderate intensity (60 - 65 % of individual maximal power output)
| Study group | Role | What they receive |
|---|---|---|
| High intensity interval training | Experimental | 3x/week the following 45 min training protocol on bicycle ergometer for 12 weeks:
* 5 minutes warm-up phase with a power output of 40% of the maximal power output achieved in an incremental exercise test
* 30 minutes: intensive cycling bouts of 60s interspersed with 60s of recovery intervals. Power output will be 90% (week 1-6) or 95% (week 7-12) of the maximal power output of the exercise test during the intensive cycling bouts. During recovery intervals, subjects will pedal with a power output of 30% (week 1-6) or 35% (week 7-12) of the maximal power output of the exercise test.
* 10 minutes with 30% of maximal power output. Receives: Behavioral: High intensity interval training (HIIT) |
| Moderate intensity continuous training | Active comparator | 3x/week the following 45 min training protocol on bicycle ergometer for 12 weeks:
* 5 minutes warm-up phase with a power output of 40% of the maximal power output achieved in an incremental exercise test
* 30 minutes: Continuous training with 60% (week 1-6) or 65% (week 7-12) of maximal power output
* 10 minutes with 30% of maximal power output. Receives: Behavioral: Moderate intensity continuous training (MICT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EC50 (half-maximal effective concentration) of TRAP-6 (thrombin-receptor activating peptide) in terms of surface CD62P (=platelet selectin, P-selectin) expression: group differences after 12 weeks of training
Measured: 12 weeks
EC50 of insulin in terms of intraplatelet VASP (vasodilator-stimulated phosphoprotein)-phosphorylation: group differences after 12 weeks of training
Measured: 12 weeks
Secondary outcomes (6)
whole body insulin sensitivity
Measured: 12 weeks
Maximal oxygen consumption
Unit: ml/min/kg bodymass
Measured: 12 weeks
EC50 of other platelet agonists in terms of various platelet activation markers
Measured: 12 weeks
EC50 of prostacyclin in terms of intraplatelet VASP-phosphorylation
Measured: 12 weeks
Transient elastography (FibroScan®) controlled attenuation parameter (CAP)
The controlled attenuation parameter (CAP) has demonstrated good accuracy in quantifying the levels of liver steatosis and fibrosis in patients with NAFLD
Measured: 12 weeks
Fatty Liver Index (FLI)
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 posted12 Dec 2018
- Study start4 Jan 2019
- Primary completionDec 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vienna, Institute for Sport Science, Sanatorium Hera Vienna
- Responsible party
- Principal investigator, Stefan Heber, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773731
- Sponsor's protocol ID
- Exercise_platelet_insulin
- Status last verified
- Jan 2019
- First submitted
- 10 Dec 2018
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of High Intensity Interval Training vs. Continuous Aerobic Training on Platelet Insulin Resistance, Platelet Function and Hepatic Steatosis in Patients With Prediabetes
- ClinicalTrials.gov ID
- NCT03773731
- Acronym / sponsor ID
- Exercise_platelet_insulin
- Conditions
- Prediabetic State
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- University of Vienna, Institute for Sport Science, Sanatorium Hera Vienna
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 12 Dec 2018 (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.
This trial investigates if high intensity interval training is more effective than moderate intensity continuous training in suppressing platelet reactivity and hepatic fat content in prediabetic individuals.
Detailed description
Background:
The prevalence of type 2 diabetes mellitus (T2DM) is rising dramatically. T2DM represents a major cause for cardiovascular disease -related mortality and morbidity and increasingly burdens healthcare systems. While the fundamental pathomechanism of T2DM is insulin resistance of muscle and adipose tissue, recent studies demonstrate that insulin resistance in T2DM also occurs in platelets. As insulin directly inhibits platelet function, this mechanism might contribute to platelet activation and platelet hyperreactivity, which were in fact detected in diabetic patients. Since (inadvertent) platelet activation is causally linked to the development of atherosclerosis and atherothrombosis, regulation of platelet function is of utmost importance. Exercise training, performed on a regular basis has been shown to reduce morbidity and mortality in sedentary and diseased populations. Furthermore, exercise training improves whole body insulin sensitivity - however, it is currently unclear, if exercise training also affects insulin sensitivity of platelets. Recently, a time-saving interval training protocol has been adapted for T2DM-patients. Since this adapted high intensity interval training (HIIT) needs a fractional time commitment of exercise training according to current guidelines, HIIT possibly represents a promising instrument to increase adherence to exercise and thereby reduce T2DM morbidity.
Aims:
The primary aim of this study is to investigate the effect of 12 weeks of HIIT vs. continuous training (CT) on platelet insulin sensitivity and platelet (hyper)reactivity in prediabetic patients.
Secondary aims are to assess the effect of HIIT and CT on whole body insulin sensitivity and fitness in prediabetic patients as well as on various parameters of platelet function and on the hepatic fat content.
Hypotheses:
Our main hypothesis is that HIIT increases platelet insulin sensitivity and thereby decreases platelet activation/reactivity in patients with prediabetes. Methods: 44 prediabetic (see inclusion criteria) patients will be enrolled in this study. Patients will randomly be assigned to a HIIT group (committed to a supervised training program) or a CT group. After initial examinations (supervised graded exercise test, platelet function tests, oral glucose tolerance test, measurement of the hepatic fat content via FibroScan®), supervised training will be performed over a period of 12 weeks. Tests performed at the beginning of the study will be repeated after the training period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity interval training | Experimental | Behavioral: High intensity interval training (HIIT)3x/week the following 45 min training protocol on bicycle ergometer for 12 weeks: * 5 minutes warm-up phase with a power output of 40% of the maximal power output achieved in an incremental exercise test * 30 minutes: intensive cycling bouts of 60s interspersed with 60s of recovery intervals. Power output will be 90% (week 1-6) or 95% (week 7-12) of the maximal power output of the exercise test during the intensive cycling bouts. During recovery intervals, subjects will pedal with a power output of 30% (week 1-6) or 35% (week 7-12) of the maximal power output of the exercise test. * 10 minutes with 30% of maximal power output. |
| Moderate intensity continuous training | Active comparator | Behavioral: Moderate intensity continuous training (MICT)3x/week the following 45 min training protocol on bicycle ergometer for 12 weeks: * 5 minutes warm-up phase with a power output of 40% of the maximal power output achieved in an incremental exercise test * 30 minutes: Continuous training with 60% (week 1-6) or 65% (week 7-12) of maximal power output * 10 minutes with 30% of maximal power output. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- prediabetic (insulin-insensitive) patients
- either fasting plasma glucose 100- 125 mg/dl or HbA1c 5.7 - 6.4
- < 3kg bodyweight change within the last 6 months
Key exclusion criteria (8 listed)
- Any contraindications for exercise
- resulting from anamnesis ( e.g. history of angina pectoris, peripheral arterial disease), ECG at rest or during graded exercise test, echocardiogram, echocardiography or lung function test
- chronical joint pain that makes exercise training on bicycle ergometers impossible
- any conditions that make the successful participation in the study unlikely
- islet cell autoantibodies
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 (HIIT)Exercise training on bicycle ergometer with high intensity bouts of 1 min interspersed by low intensity recovery intervals | Behavioural | High intensity interval training |
| Moderate intensity continuous training (MICT)Exercise training on bicycle ergometer with moderate intensity (60 - 65 % of individual maximal power output) | Behavioural | Moderate intensity continuous training |
Primary outcome
EC50 (half-maximal effective concentration) of TRAP-6 (thrombin-receptor activating peptide) in terms of surface CD62P (=platelet selectin, P-selectin) expression: group differences after 12 weeks of training
Time frame: 12 weeks
EC50 of insulin in terms of intraplatelet VASP (vasodilator-stimulated phosphoprotein)-phosphorylation: group differences after 12 weeks of training
Time frame: 12 weeks
6 secondary outcomes
whole body insulin sensitivity
Time frame: 12 weeks
Maximal oxygen consumption
Time frame: 12 weeks
EC50 of other platelet agonists in terms of various platelet activation markers
Time frame: 12 weeks
EC50 of prostacyclin in terms of intraplatelet VASP-phosphorylation
Time frame: 12 weeks
Transient elastography (FibroScan®) controlled attenuation parameter (CAP)
Time frame: 12 weeks
Fatty Liver Index (FLI)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- 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.
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 (HIIT) and Moderate intensity continuous training (MICT) in people with Prediabetic State, run by Medical University of Vienna at 1 site in Austria.
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 8 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: status not confirmed, as of the sponsor's last update on 9 Jan 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ivo Volf, PhD (+43 40160 ext. 31421, ivo.volf@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EC50 (half-maximal effective concentration) of TRAP-6 (thrombin-receptor activating peptide) in terms of surface CD62P (=platelet selectin, P-selectin) expression: group differences after 12 weeks of training (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2019.