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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
History of Changes
  Purpose

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.

Condition Intervention
Obesity
 Behavioral: habitual sleep length period + extended sleep length period
Behavioral: extended sleep length period + habitual sleep length period

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Sleep and Obesity in Teenagers: Impact of Sleep Length and Quality on Obesity and Diabetes Risks in Teenagers.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 26
Study Start Date: February 2009
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   15 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841347

Contacts
Contact: Behrouz KASSAI, MD 472 357 231 ext +33 behrouz.kassai-koupai@chu-lyon.fr

Locations
France
Hospices Civils de Lyon Recruiting
Lyon, France, 69 002
Principal Investigator: Behrouz KASSAI, MD            
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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
  More Information

No publications provided

Responsible Party: Behrouz KASSAI, MD, Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00841347     History of Changes
Other Study ID Numbers: 2008.525
Study First Received: February 10, 2009
Last Updated: December 22, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Obesity
Glucose metabolism disorders
Appetite regulation
 Sleep
Adolescent
Randomized controlled trials

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013