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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02125656
Other study ID # 475074/2011-4
Secondary ID
Status Active, not recruiting
Phase N/A
First received April 25, 2014
Last updated May 7, 2015
Start date February 2014
Est. completion date May 2015

Study information

Verified date May 2015
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 15
Est. completion date May 2015
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Healthy

- Recreationally Active

- Eutrophic

- Sleep Duration about 7-8 hours

Exclusion Criteria:

- No Smoking

- Without Sleep disorders

- Nondiabetic

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
High Intensity Interval Training
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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Federal University of São Paulo Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from Baseline in Blood Glucose at 2 weeks of high intensity interval training Yes
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