Sleep and Obesity in Teenagers

August 2, 2017 updated by: Hospices Civils de Lyon

Sleep and Obesity in Teenagers: Impact of Sleep Length and Quality on Obesity and Diabetes Risks in Teenagers.

This study aims to investigate

  1. whether sleep extension results in improvements of endocrine and metabolic markers of obesity and diabetes in obese teenagers,
  2. the relationship between habitual sleep quality and duration and markers of obesity and diabetes in lean and obese teenagers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Inclusion of 13 obese teens. Duration : 1 week of screening period + 1 week of intervention: habitual/extended sleep length + 1 week of intervention: extended/habitual sleep length. A wash out period of at least 3 months will be required between the two interventions.

Inclusion of 13 non obese healthy teen controls for measuring reference sleep duration and physiology level. Duration for these group: 1 week of screening period + 1 week of habitual sleep length

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69 002
        • Hospices Civils de Lyon

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

15 years to 17 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female over 15 and under 18 year-old.
  • Teenager with normal weight or stage 2 obesity, according to international standards (WHO)
  • Post-pubescent teenagers (menstruation for girls and stage 4-5 of Tanner scale for boys)
  • Teens with an social security
  • Girl with negative urine pregnancy test

Exclusion Criteria:

  • Active smoker (interview)
  • Refuse consent (parents or teen)
  • Addiction such as coffee, drug…(interview)
  • Medicinal treatment that may influence sleep and measured variables (interview)
  • Obesity diagnosis : less than 1 year (interview)
  • Concomitant diseases : renal or hepatic failure, iron deficit, diabetes, endocrinal pathology, hypertension
  • Anxiety (Spielberg>56), , depression (CDI>19).
  • Mild or sever insomnia (ISI>15), poor sleep quality (PSQI >10), excessive sleepiness (Epworth>10, sleep) length>9 hour), extreme circadian typology (Horne et Ostberg from 70 to 86 or 16 to 30)
  • Blood sample taken within the last two months before inclusion
  • Mild or severe sleep apnoea or excessive leg movements according to EEG analysis

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: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: 1
Study of habitual sleep length on non obese teen group
EXPERIMENTAL: 2
Study of habitual sleep length period followed by extended sleep length period on obese teen group
Behavioral: habitual sleep length period + extended sleep length period
On obese group, realisation of an habitual sleep length period followed by an extended sleep length period
EXPERIMENTAL: 3
Study of extended sleep length period followed by habitual sleep length period on obese teen group
Behavioral: extended sleep length period + habitual sleep length period
On obese group, realisation of an extended sleep length period followed by an habitual sleep length period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The influence of sleep extension on leptin level for the obese teens group.
Time Frame: at the end of each sleep experimental period
at the end of each sleep experimental period

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference between the two groups (obese vs non-obese) regarding sleep length and delta waves activity.
Time Frame: during each sleep experimental period (habitual or extended)
during each sleep experimental period (habitual or extended)
Study the correlation between delta waves activity and habitual sleep length
Time Frame: During each sleep experimental period
During each sleep experimental period
Study the correlation between delta waves activity and psychological, behavioural, anthropometric and physiological markers of obesity and its co morbidities
Time Frame: During each sleep experimental period
During each sleep experimental period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Study Chair: Karine SPIEGEL, PhD, Institut National de la Santé Et de la Recherche Médicale, France

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, 2009

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

February 10, 2009

First Submitted That Met QC Criteria

February 10, 2009

First Posted (ESTIMATE)

February 11, 2009

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2017

Last Update Submitted That Met QC Criteria

August 2, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008.525

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.

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