Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2009-02-28
2014-05-31
Brief Summary
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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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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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1
Study of habitual sleep length on non obese teen group
No interventions assigned to this group
2
Study of habitual sleep length period followed by extended sleep length period on obese teen group
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
3
Study of extended sleep length period followed by habitual sleep length period on obese teen group
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
15 Years
17 Years
ALL
Yes
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Karine SPIEGEL, PhD
Role: STUDY_CHAIR
Institut National de la Santé Et de la Recherche Médicale, France
Behrouz KASSAI, MD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Hospices Civils de Lyon
Lyon, , France
Countries
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Other Identifiers
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2008.525
Identifier Type: -
Identifier Source: org_study_id
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