Sleep and Obesity in Teenagers

Study Overview
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Brief Summary
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This study aims to investigate whether sleep extension results in improvements of endocrine and metabolic markers of obesity and diabetes in obese teenagers, the relationship between habitual sleep quality and duration and markers of obesity and diabetes in lean and obese teenagers.

Detailed Description
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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

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: habitual sleep length period + extended sleep length period
* Behavioral: extended sleep length period + habitual sleep length period


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Study of habitual sleep length on non obese teen group | |
| Experimental: 2<br>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<br>* On obese group, realisation of an habitual sleep length period followed by an extended sleep length period<br>|
| Experimental: 3<br>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<br>* On obese group, realisation of an extended sleep length period followed by an habitual sleep length period<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between the two groups (obese vs non-obese) regarding sleep length and delta waves activity. |  | during each sleep experimental period (habitual or extended) | 
| Study the correlation between delta waves activity and habitual sleep length |  | 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 |  | During each sleep experimental period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Glucose metabolism disorders, Appetite regulation, Sleep, Adolescent, Randomized controlled trials