Prader-Willi SyndromeNCT01622751
Plasma Adiponectin Level and Sleep Structures in Children With Prader-Willi Syndrome
An observational study of Prader-Willi Syndrome and Obesity, run by Samsung Medical Center.
Trial summary
Context: Adiponectin is an adipose tissue-derived hormone with an insulin sensitizing effect, and has been related to obstructive sleep apnea syndrome. In addition, children with Prader-Willi syndrome (PWS) suffer from excessive daytime sleepiness and the abnormality of rapid eye movement (REM) sleep. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Prader-Willi Syndrome, Obesity
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Jun 2007
- Phase
- Observational
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population comprised 28 children with PWS and 18 controls. The enrolled children with PWS were volunteers from a pool of approximately 100 children with PWS followed up at the Samsung Medical Center. The controls were healthy children from several elementary and middle schools located in the southern areas of Seoul.
Who may be able to join
- Prader Willi syndrome healthy children
Who cannot join
- history of seizure,
- mental or brain illness,
- adenoidectomy,
- tonsillectomy,
- craniofacial anomalies and any treatment at the time of the study.
About this study
Context: Adiponectin is an adipose tissue-derived hormone with an insulin sensitizing effect, and has been related to obstructive sleep apnea syndrome. In addition, children with Prader-Willi syndrome (PWS) suffer from excessive daytime sleepiness and the abnormality of rapid eye movement (REM) sleep.
Objective: To determine if the sleep stages are related to the plasma levels of adiponectin, resistin, and RBP4 (retinol binding protein-4), and whether these relationships are influenced by age, obesity and insulin resistance.
Read the detailed description
This comparative study was carried out in 28 PWS children and 18 controls. The enrolled PWS children were volunteers out of a pool of approximately 100 PWS children followed at Samsung Medical Center [median age 8.0 years, interquartile range (7.0-10.5 years), BMI: median 24.2 kg/m2 (23.0-27.5 kg/m2)] and 18 obese healthy children [median age 9.0 years interquartile range (7.0-11.0 years), BMI: median 24.2 kg/m2 interquartile range (23.1-27.6 kg/m2)].
- Conditions
- Prader-Willi Syndrome, Obesity
- Keywords
- REM sleep, Adiponectin, Prader-Willi syndrome
- Medical subject headings
- Prader-Willi Syndrome, Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startJan 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prader-Willi SyndromeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Dong-Kyu Jin, M.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622751
- Sponsor's protocol ID
- 2006-09-055
- Status last verified
- Jun 2012
- First submitted
- 18 Jan 2012
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Adiponectin Level and Sleep Structures in Children With Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT01622751
- Acronym / sponsor ID
- 2006-09-055
- Conditions
- Prader-Willi Syndrome, Obesity
- Keywords
- REM sleep, Adiponectin, Prader-Willi syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Jun 2007 (actual)
- First posted
- 19 Jun 2012 (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.
Context: Adiponectin is an adipose tissue-derived hormone with an insulin sensitizing effect, and has been related to obstructive sleep apnea syndrome. In addition, children with Prader-Willi syndrome (PWS) suffer from excessive daytime sleepiness and the abnormality of rapid eye movement (REM) sleep.
Objective: To determine if the sleep stages are related to the plasma levels of adiponectin, resistin, and RBP4 (retinol binding protein-4), and whether these relationships are influenced by age, obesity and insulin resistance.
Detailed description
This comparative study was carried out in 28 PWS children and 18 controls. The enrolled PWS children were volunteers out of a pool of approximately 100 PWS children followed at Samsung Medical Center [median age 8.0 years, interquartile range (7.0-10.5 years), BMI: median 24.2 kg/m2 (23.0-27.5 kg/m2)] and 18 obese healthy children [median age 9.0 years interquartile range (7.0-11.0 years), BMI: median 24.2 kg/m2 interquartile range (23.1-27.6 kg/m2)].
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population comprised 28 children with PWS and 18 controls. The enrolled children with PWS were volunteers from a pool of approximately 100 children with PWS followed up at the Samsung Medical Center. The controls were healthy children from several elementary and middle schools located in the southern areas of Seoul.
Key inclusion criteria (1 listed)
- Prader Willi syndrome healthy children
Key exclusion criteria (5 listed)
- history of seizure,
- mental or brain illness,
- adenoidectomy,
- tonsillectomy,
- craniofacial anomalies and any treatment at the time of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 19 Jun 2012.
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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.
Dong-Kyu Jin, M.D. principal investigator
Samsung Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Prader-Willi Syndrome and Obesity, run by Samsung Medical Center.
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 1 inclusion and 5 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 19 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
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 19 Jun 2012.