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Sleep and Obesity in Teenagers

Primary Purpose

Obesity

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

habitual sleep length period + extended sleep length period

extended sleep length period + habitual sleep length period

About this trial

This is an interventional basic science trial for Obesity focused on measuring Obesity, Glucose metabolism disorders, Appetite regulation, Sleep, Adolescent, Randomized controlled trials

Eligibility Criteria

15 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

Arm Description

Study of habitual sleep length on non obese teen group

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Difference between the two groups (obese vs non-obese) regarding sleep length and delta waves activity.

Study the correlation between delta waves activity and habitual sleep length

Study the correlation between delta waves activity and psychological, behavioural, anthropometric and physiological markers of obesity and its co morbidities

Full Information

NCT ID

NCT00841347

First Posted

February 10, 2009

Last Updated

August 2, 2017

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT00841347

Brief Title

Sleep and Obesity in Teenagers

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

Obesity, Glucose metabolism disorders, Appetite regulation, Sleep, Adolescent, Randomized controlled trials

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

No Intervention

Arm Description

Study of habitual sleep length on non obese teen group

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

habitual sleep length period + extended sleep length period

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

extended sleep length period + habitual sleep length period

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

at the end of each sleep experimental period

Secondary Outcome Measure Information:

Title

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)

Title

Study the correlation between delta waves activity and habitual sleep length

Time Frame

During each sleep experimental period

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karine SPIEGEL, PhD

Organizational Affiliation

Institut National de la Santé Et de la Recherche Médicale, France

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Behrouz KASSAI, MD

Organizational Affiliation

Hospices Civils de Lyon

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospices Civils de Lyon

City

Lyon

ZIP/Postal Code

69 002

Country

France

12. IPD Sharing Statement

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Sleep and Obesity in Teenagers

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