Clinical trial NCT00841347: Sleep and Obesity in Teenagers
Official title: Sleep and Obesity in Teenagers: Impact of Sleep Length and Quality on Obesity and Diabetes Risks in Teenagers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Glucose metabolism disorders
Appetite regulation
Sleep
Adolescent
Randomized controlled trials
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2009-02-11
Enrollment: 41
Sex: ALL
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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 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

Primary outcomes:
measure: The influence of sleep extension on leptin level for the obese teens group.
timeFrame: at the end of each sleep experimental period
Secondary outcomes:
measure: Difference between the two groups (obese vs non-obese) regarding sleep length and delta waves activity.
timeFrame: during each sleep experimental period (habitual or extended)
measure: Study the correlation between delta waves activity and habitual sleep length
timeFrame: During each sleep experimental period
measure: Study the correlation between delta waves activity and psychological, behavioural, anthropometric and physiological markers of obesity and its co morbidities
timeFrame: During each sleep experimental period
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Karine SPIEGEL, PhD
role: STUDY_CHAIR
affiliation: Hospices Civils de Lyon
name: Behrouz KASSAI, MD
role: PRINCIPAL_INVESTIGATOR
References: