NCT00841347

Brief Summary

This study aims to investigate

  1. 1.whether sleep extension results in improvements of endocrine and metabolic markers of obesity and diabetes in obese teenagers,
  2. 2.the relationship between habitual sleep quality and duration and markers of obesity and diabetes in lean and obese teenagers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

5.2 years

First QC Date

February 10, 2009

Last Update Submit

August 2, 2017

Conditions

Obesity

Keywords

ObesityGlucose metabolism disordersAppetite regulationSleepAdolescentRandomized controlled trials

Outcome Measures

Primary Outcomes (1)

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

    at the end of each sleep experimental period

Secondary Outcomes (3)

  • 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

Study Arms (3)

1

NO INTERVENTION

Study of habitual sleep length on non obese teen group

2

EXPERIMENTAL

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

Behavioral: habitual sleep length period + extended sleep length period

3

EXPERIMENTAL

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

Behavioral: extended sleep length period + habitual sleep length period

Interventions

habitual sleep length period + extended sleep length periodBEHAVIORAL

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

2
extended sleep length period + habitual sleep length periodBEHAVIORAL

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

3

Eligibility Criteria

Age15 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • Mild or severe sleep apnoea or excessive leg movements according to EEG analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69 002, France

Location

MeSH Terms

Conditions

ObesityGlucose Metabolism Disorders

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMetabolic Diseases

Study Officials

  • Karine SPIEGEL, PhD

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

    STUDY CHAIR

  • Behrouz KASSAI, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 11, 2009

Study Start

February 1, 2009

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

August 3, 2017

Record last verified: 2017-08

Locations

FR(1)