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Completed

NCT Number: NCT00841347

Sleep and Obesity 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.

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Key information

Age range

15 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon

Lyon, 69 002, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

habitual sleep length period + extended sleep length period

Behavioral

On obese group, realisation of an habitual sleep length period followed by an extended sleep length period

extended sleep length period + habitual sleep length period

Behavioral

On obese group, realisation of an extended sleep length period followed by an habitual sleep length period

Primary outcomes

  1. The influence of sleep extension on leptin level for the obese teens group.

    Time frame: at the end of each sleep experimental period

Secondary outcomes

  1. 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)

  2. Study the correlation between delta waves activity and habitual sleep length

    Time frame: During each sleep experimental period

  3. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Feb 11, 2009
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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