Sleep and Obesity in Teenagers

NCT ID: NCT00841347

Last Updated: 2017-08-03

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2014-05-31

Brief Summary

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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

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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

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Study of habitual sleep length on non obese teen group

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Study of habitual sleep length period followed by extended sleep length period on obese teen group

Group Type EXPERIMENTAL

habitual sleep length period + extended sleep length period

Intervention Type BEHAVIORAL

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

Group Type EXPERIMENTAL

extended sleep length period + habitual sleep length period

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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France

Other Identifiers

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2008.525

Identifier Type: -

Identifier Source: org_study_id

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