NCT02125656

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 8, 2015

Status Verified

May 1, 2015

Enrollment Period

5 months

First QC Date

April 25, 2014

Last Update Submit

May 7, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

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.

Other: High Intensity Interval Training

HIIT + Sleep Deprivation

EXPERIMENTAL

2 weeks of HIIT and after a single night of sleep deprivation

Other: High Intensity Interval Training

Interventions

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.

HIIT + Regular SleepHIIT + Sleep Deprivation

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Recreationally Active
  • Eutrophic
  • Sleep Duration about 7-8 hours

You may not qualify if:

  • No Smoking
  • Without Sleep disorders
  • Nondiabetic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Insulin ResistanceSleep Deprivation

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jorge FT de Souza, Msc

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 25, 2014

First Posted

April 29, 2014

Study Start

February 1, 2014

Primary Completion

July 1, 2014

Study Completion

May 1, 2015

Last Updated

May 8, 2015

Record last verified: 2015-05