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Sleep and Obesity in Teenagers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Hospices Civils de Lyon.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00841347
First received: February 10, 2009
Last updated: December 22, 2010
Last verified: December 2010

February 10, 2009
December 22, 2010
February 2009
February 2012   (final data collection date for primary outcome measure)
The influence of sleep extension on leptin level for the obese teens group. [ Time Frame: at the end of each sleep experimental period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00841347 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]
  • Study the correlation between delta waves activity and habitual sleep length [ Time Frame: During each sleep experimental period ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Sleep and Obesity in Teenagers
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.

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

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Obesity
  • 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
  • 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
  • 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
    Intervention: Behavioral: habitual sleep length period + extended sleep length period
  • Experimental: 3
    Study of extended sleep length period followed by habitual sleep length period on obese teen group
    Intervention: Behavioral: extended sleep length period + habitual sleep length period
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
26
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
15 Years to 17 Years
Yes
Contact: Behrouz KASSAI, MD 472 357 231 ext +33 behrouz.kassai-koupai@chu-lyon.fr
France
 
NCT00841347
2008.525
No
Behrouz KASSAI, MD, Hospices Civils de Lyon
Hospices Civils de Lyon
Not Provided
Study Chair: Karine SPIEGEL, PhD Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Behrouz KASSAI, MD Hospices Civils de Lyon
Hospices Civils de Lyon
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP