NCT01622751

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2007

Shorter than P25 for all trials

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

January 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 19, 2012

Completed
Last Updated

June 19, 2012

Status Verified

June 1, 2012

First QC Date

January 18, 2012

Last Update Submit

June 14, 2012

Conditions

Keywords

REM sleepAdiponectinPrader-Willi syndrome

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Prader Willi syndrome healthy children

You may not qualify if:

  • history of seizure,
  • mental or brain illness,
  • adenoidectomy,
  • tonsillectomy,
  • craniofacial anomalies and any treatment at the time of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prader-Willi SyndromeObesity

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornImprinting DisordersOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dong-Kyu Jin, M.D.

    Samsung Medical Center, Sungkyunkwan University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 18, 2012

First Posted

June 19, 2012

Study Start

January 1, 2007

Study Completion

June 1, 2007

Last Updated

June 19, 2012

Record last verified: 2012-06