Sleep and Obesity in Teenagers

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: habitual sleep length period + extended sleep length period; Behavioral: extended sleep length period + habitual sleep length period

• Registration Number: NCT00841347
• Lead Sponsor: Hospices Civils de Lyon

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

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-11
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	habitual sleep length period + extended sleep length period	Study of habitual sleep length period followed by extended sleep length period on obese teen group
3	extended sleep length period + habitual sleep length period	Study of extended sleep length period followed by habitual sleep length period on obese teen group

Primary Outcome Measures

Name	Time	Method
The influence of sleep extension on leptin level for the obese teens group.	at the end of each sleep experimental period

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France