Viewing Study NCT01622751


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Study NCT ID: NCT01622751
Status: COMPLETED
Last Update Posted: 2012-06-19
First Post: 2012-01-18
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Plasma Adiponectin Level and Sleep Structures in Children With Prader-Willi Syndrome
Sponsor: Samsung Medical Center
Organization:

Study Overview

Official Title: Plasma Adiponectin Level and Sleep Structures in Children With Prader-Willi Syndrome
Status: COMPLETED
Status Verified Date: 2012-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.
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 Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: