ObesityNCT00841347
Sleep and Obesity in Teenagers
A study testing habitual sleep length period + extended sleep length period and extended sleep length period + habitual sleep length period in people with Obesity, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- habitual sleep length period + extended sleep length period and extended sleep length period + habitual sleep length period
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep and Obesity in Teenagers: Impact of Sleep Length and Quality on Obesity and Diabetes Risks in Teenagers.
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.
Read the 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
- Conditions
- Obesity
- Being tested
- habitual sleep length period + extended sleep length period, extended sleep length period + habitual sleep length period
- Keywords
- Obesity, Glucose metabolism disorders, Appetite regulation, Sleep, Adolescent, Randomized controlled trials
- Medical subject headings
- Obesity, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
habitual sleep length period + extended sleep length periodBehavioural
On obese group, realisation of an habitual sleep length period followed by an extended sleep length period
extended sleep length period + habitual sleep length periodBehavioural
On obese group, realisation of an extended sleep length period followed by an habitual sleep length period
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: extended sleep length period + habitual sleep length period |
What is being measured
The primary outcome is the main question the study is designed to answer.
The influence of sleep extension on leptin level for the obese teens group.
Measured: 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.
Measured: during each sleep experimental period (habitual or extended)
Study the correlation between delta waves activity and habitual sleep length
Measured: 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
Measured: During each sleep experimental period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karine SPIEGEL, PhD, Study chair, Institut National de la Santé Et de la Recherche Médicale, FranceBehrouz KASSAI, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841347
- Sponsor's protocol ID
- 2008.525
- Status last verified
- Aug 2017
- First submitted
- 10 Feb 2009
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Obesity in Teenagers: Impact of Sleep Length and Quality on Obesity and Diabetes Risks in Teenagers.
- ClinicalTrials.gov ID
- NCT00841347
- Acronym / sponsor ID
- 2008.525
- Conditions
- Obesity
- Keywords
- Obesity, Glucose metabolism disorders, Appetite regulation, Sleep, Adolescent, Randomized controlled trials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 11 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Study of habitual sleep length on non obese teen group |
| 2 | Experimental | Behavioral: habitual sleep length period + extended sleep length periodStudy of habitual sleep length period followed by extended sleep length period on obese teen group |
| 3 | Experimental | Behavioral: extended sleep length period + habitual sleep length periodStudy of extended sleep length period followed by habitual sleep length period on obese teen group |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| habitual sleep length period + extended sleep length periodOn obese group, realisation of an habitual sleep length period followed by an extended sleep length period | Behavioural | 2 |
| extended sleep length period + habitual sleep length periodOn obese group, realisation of an extended sleep length period followed by an habitual sleep length period | Behavioural | 3 |
Primary outcome
The influence of sleep extension on leptin level for the obese teens group.
Time frame: at the end of each sleep experimental period
3 secondary outcomes
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)
Study the correlation between delta waves activity and habitual sleep length
Time frame: 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
Time frame: During each sleep experimental period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karine SPIEGEL, PhD study chair
Institut National de la Santé Et de la Recherche Médicale, France
Behrouz KASSAI, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing habitual sleep length period + extended sleep length period and extended sleep length period + habitual sleep length period in people with Obesity, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The influence of sleep extension on leptin level for the obese teens group. (time frame: at the end of each sleep experimental period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017.