Sleep Disordered Breathing and Impaired Glucose Homeostasis in Obese Children
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|ClinicalTrials.gov Identifier: NCT02037100|
Recruitment Status : Unknown
Verified January 2014 by Tel-Aviv Sourasky Medical Center.
Recruitment status was: Recruiting
First Posted : January 15, 2014
Last Update Posted : January 15, 2014
SDB has been identified as an important risk factor for insulin resistance and the metabolic syndrome.
In a recent study in patients with SDB and T2DM it was shown that CPAP therapy can lead to improvements in postprandial glucose levels and in glycosylated hemoglobin levels (HbA1c).
In children, there are only 3 studies that have examined the relations between SDB, obesity and the metabolic syndrome.
In order to further understand the relative contribution of SDB to the development of impaired glucose homeostasis and metabolic abnormalities we aim to investigate the prevalence and severity of SDB in children with T2DM compared to obese children without T2DM. The investigators hypothesize that SDB will be more prevalent and more severe among obese children with T2DM compared with the general obese pediatric population.
|Condition or disease|
|SDB T2DM Obesity|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Observational Model:||Case Control|
|Official Title:||Sleep Disordered Breathing and Impaired Glucose Homeostasis in Obese Children|
|Study Start Date :||June 2007|
|Estimated Primary Completion Date :||September 2014|
Children 6-20 years old diagnosed with T2DM
- Investigate the prevalence and severity of SDB among children with T2DM compared to its prevalence in non-diabetic obese children. [ Time Frame: In 6 months ]
- To measure markers of inflammation and oxidative stress known to be associated with cardiovascular morbidity in children with T2DM and SDB compared to non-diabetic obese children. [ Time Frame: In 6 months ]
- To examine changes in metabolic measures and markers of inflammation and oxidative stress in response to treatment for SDB (adenotonsillectomy) in children with T2DM compared to obese children without T2DM. [ Time Frame: In 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02037100
|Contact: Riva Tauman, Dr.||firstname.lastname@example.org|
|Sourasky Medical Center||Recruiting|