Plasma Adiponectin Level and Sleep Structures in Children With Prader-Willi Syndrome

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01622751
First received: January 18, 2012
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

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.


Condition
Prader-Willi Syndrome
Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Plasma Adiponectin Level and Sleep Structures in Children With Prader-Willi Syndrome

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Enrollment: 46
Study Start Date: January 2007
Study Completion Date: June 2007
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)].

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability 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.

Criteria

Inclusion Criteria:

  • Prader Willi syndrome healthy children

Exclusion Criteria:

  • history of seizure,
  • mental or brain illness,
  • adenoidectomy,
  • tonsillectomy,
  • craniofacial anomalies and any treatment at the time of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01622751

Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Dong-Kyu Jin, M.D. Samsung Medical Center, Sungkyunkwan University School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01622751     History of Changes
Other Study ID Numbers: 2006-09-055
Study First Received: January 18, 2012
Last Updated: June 14, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
REM sleep
Adiponectin
Prader-Willi syndrome

Additional relevant MeSH terms:
Prader-Willi Syndrome
Syndrome
Abnormalities, Multiple
Chromosome Disorders
Congenital Abnormalities
Disease
Genetic Diseases, Inborn
Intellectual Disability
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Nutrition Disorders
Obesity
Overnutrition
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014