Insulin ResistanceHIITNCT02125656
Use of High Intensity Interval Training as a Strategy to Minimize the Insulin Resistance Observed in Sleep Deprivation
A study testing High Intensity Interval Training in people with Insulin Resistance and Sleep Deprivation, run by Federal University of São Paulo.
Trial summary
Sleep is an essential biological process for life and great value to functions such as learning, memory processing , cell and brain repair. Recently, new evidence points to the relationship between lack of sleep and carbohydrate metabolism , establishing a framework for insulin resistance observed in studies with… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Sleep Deprivation
- What is being tested?
- High Intensity Interval Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to May 2015
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Recreationally Active
- Eutrophic
- Sleep Duration about 7-8 hours
Who cannot join
- No Smoking
- Without Sleep disorders
- Nondiabetic
About this study
Sleep is an essential biological process for life and great value to functions such as learning, memory processing , cell and brain repair. Recently, new evidence points to the relationship between lack of sleep and carbohydrate metabolism , establishing a framework for insulin resistance observed in studies with restriction and sleep deprivation on several nights and in a single night . To reverse this process , one of the most effective strategies is physical exercise and part listed in the literature as a non-pharmacological tool for prevention and health promotion , as well as in the treatment of some diseases . However , the pace of modern society causes people to practice less physical exercise , lack of time being the main reason . In this scenario, the High Intensity Interval Training ( HIIT ) emerges as a powerful strategy that induces major changes optimizing the time spent on such activity. Considering the benefits of this mode , the purpose of this study is to investigate the effects of high-intensity interval training in the context of insulin resistance observed during sleep deprivation. Will be recruited 20 male volunteers, aged between 18 and 35 years old, healthy, with normal sleep duration equivalent to 7-8 hours / night, not smoking and regular eating habits. They will be submitted to a protocol of 6 sessions of high-intensity interval training for two weeks, and since the end period, sleep normally, or be deprived of sleep for 24 hours. Biochemical (thyroid hormones, cortisol, glucagon, free fatty acid, cholesterol, glucose and insulin) will be undertaken as well as evaluation of body composition by plethysmography, basal metabolic rate by indirect calorimetry and insulin sensitivity through Oral Glucose Tolerance Test (OGTT) before and after the training period.
- Conditions
- Insulin Resistance, Sleep Deprivation
- Being tested
- High Intensity Interval Training
- Medical subject headings
- Insulin Resistance, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval TrainingOther
6 sessions in 2 weeks (Monday, Wednesday and Friday). Each training session will consist of repeated high-intensity efforts in a workload that matches the peak oxygen uptake for 60 seconds. These sprints are interspersed with active recovery for 75 seconds on low intensity (30W). The training sessions will have three minutes of heating in 30W. There will be 8 shots in the first and second session, 10 shots in the third and fourth session and 12 shots in the fifth and sixth session.
| Study group | Role | What they receive |
|---|---|---|
| Regular Sleep | No intervention | A single night of regular sleep |
| Sleep Deprivation | No intervention | A single night of sleep deprivation |
| HIIT + Regular Sleep | Experimental | 2 weeks of HIIT and after a single night of regular sleep. Receives: Other: High Intensity Interval Training |
| HIIT + Sleep Deprivation | Experimental | 2 weeks of HIIT and after a single night of sleep deprivation Receives: Other: High Intensity Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Blood Glucose
Oral Glucose Tolerance Test (OGTT) is performed after at least 8 hours of fasting overnight, by oral administration of standard dose of 75g anhydrous glucose dissolved in water (dextrose). The plasma glucose levels are fasting measured (before administration of glucose state) and 30, 60, 90, 120, 180 and 240 minutes after administration. Volunteers will be advised to follow the same eating patterns before testing.
Measured: Change from Baseline in Blood Glucose at 2 weeks of high intensity interval training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Hanna Karen Moreira Antunes, Federal University of São Paulo
- Investigators
- Jorge FT de Souza, Msc, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125656
- Sponsor's protocol ID
- 475074/2011-4
- Acronym
- HIIT
- Status last verified
- May 2015
- First submitted
- 25 Apr 2014
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of High Intensity Interval Training as a Strategy to Minimize the Insulin Resistance Observed in Sleep Deprivation
- ClinicalTrials.gov ID
- NCT02125656
- Acronym / sponsor ID
- HIIT / 475074/2011-4
- Conditions
- Insulin Resistance, Sleep Deprivation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- May 2015 (estimated)
- First posted
- 29 Apr 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.
Sleep is an essential biological process for life and great value to functions such as learning, memory processing , cell and brain repair. Recently, new evidence points to the relationship between lack of sleep and carbohydrate metabolism , establishing a framework for insulin resistance observed in studies with restriction and sleep deprivation on several nights and in a single night . To reverse this process , one of the most effective strategies is physical exercise and part listed in the literature as a non-pharmacological tool for prevention and health promotion , as well as in the treatment of some diseases . However , the pace of modern society causes people to practice less physical exercise , lack of time being the main reason . In this scenario, the High Intensity Interval Training ( HIIT ) emerges as a powerful strategy that induces major changes optimizing the time spent on such activity. Considering the benefits of this mode , the purpose of this study is to investigate the effects of high-intensity interval training in the context of insulin resistance observed during sleep deprivation. Will be recruited 20 male volunteers, aged between 18 and 35 years old, healthy, with normal sleep duration equivalent to 7-8 hours / night, not smoking and regular eating habits. They will be submitted to a protocol of 6 sessions of high-intensity interval training for two weeks, and since the end period, sleep normally, or be deprived of sleep for 24 hours. Biochemical (thyroid hormones, cortisol, glucagon, free fatty acid, cholesterol, glucose and insulin) will be undertaken as well as evaluation of body composition by plethysmography, basal metabolic rate by indirect calorimetry and insulin sensitivity through Oral Glucose Tolerance Test (OGTT) before and after the training period.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Regular Sleep | No intervention | –A single night of regular sleep |
| Sleep Deprivation | No intervention | –A single night of sleep deprivation |
| HIIT + Regular Sleep | Experimental | Other: High Intensity Interval Training2 weeks of HIIT and after a single night of regular sleep. |
| HIIT + Sleep Deprivation | Experimental | Other: High Intensity Interval Training2 weeks of HIIT and after a single night of sleep deprivation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- Recreationally Active
- Eutrophic
- Sleep Duration about 7-8 hours
Key exclusion criteria (3 listed)
- No Smoking
- Without Sleep disorders
- Nondiabetic
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 Training6 sessions in 2 weeks (Monday, Wednesday and Friday). Each training session will consist of repeated high-intensity efforts in a workload that matches the peak oxygen uptake for 60 seconds. These sprints are interspersed with active recovery for 75 seconds on low intensity (30W). The training sessions will have three minutes of heating in 30W. There will be 8 shots in the first and second session, 10 shots in the third and fourth session and 12 shots in the fifth and sixth session. | Other | HIIT + Regular Sleep, HIIT + Sleep Deprivation |
Primary outcome
Change from Baseline in Blood Glucose
Time frame: Change from Baseline in Blood Glucose at 2 weeks of high intensity interval training
Oral Glucose Tolerance Test (OGTT) is performed after at least 8 hours of fasting overnight, by oral administration of standard dose of 75g anhydrous glucose dissolved in water (dextrose). The plasma glucose levels are fasting measured (before administration of glucose state) and 30, 60, 90, 120, 180 and 240 minutes after administration. Volunteers will be advised to follow the same eating patterns before testing.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
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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.
Jorge FT de Souza, Msc principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training in people with Insulin Resistance and Sleep Deprivation, run by Federal University of São Paulo.
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 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: status not confirmed, as of the sponsor's last update on 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change from Baseline in Blood Glucose (time frame: Change from Baseline in Blood Glucose at 2 weeks of high intensity interval training). 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 8 May 2015.