- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02125656
Use of High Intensity Interval Training as a Strategy to Minimize the Insulin Resistance Observed in Sleep Deprivation (HIIT)
May 7, 2015 updated by: Hanna Karen Moreira Antunes, Federal University of São Paulo
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy
- Recreationally Active
- Eutrophic
- Sleep Duration about 7-8 hours
Exclusion Criteria:
- No Smoking
- Without Sleep disorders
- Nondiabetic
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Regular Sleep
A single night of regular sleep
|
|
|
No Intervention: Sleep Deprivation
A single night of sleep deprivation
|
|
|
Experimental: HIIT + Regular Sleep
2 weeks of HIIT and after a single night of regular sleep.
|
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.
|
|
Experimental: HIIT + Sleep Deprivation
2 weeks of HIIT and after a single night of sleep deprivation
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Change from Baseline in Blood Glucose at 2 weeks of high intensity interval training
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jorge FT de Souza, Msc, Federal University of São Paulo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
July 1, 2014
Study Completion (Anticipated)
May 1, 2015
Study Registration Dates
First Submitted
April 25, 2014
First Submitted That Met QC Criteria
April 27, 2014
First Posted (Estimate)
April 29, 2014
Study Record Updates
Last Update Posted (Estimate)
May 8, 2015
Last Update Submitted That Met QC Criteria
May 7, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 475074/2011-4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.