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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01622751
• Other study ID #: 2006-09-055
• Status: Completed
• Phase: N/A
• First received: January 18, 2012
• Last updated: June 14, 2012
• Start date: January 2007
• Est. completion date: June 2007

Study information

• Verified date: June 2012
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

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)].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity
• Prader-Willi Syndrome
• Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center