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Sleep Disordered Breathing and Impaired Glucose Homeostasis in Obese Children

Conditions
SDB
T2DM
Obesity
Registration Number
NCT02037100
Lead Sponsor
Tel-Aviv Sourasky Medical Center
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
40
Inclusion Criteria
  • diagnosed with T2DM
  • obese
Exclusion Criteria

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Investigate the prevalence and severity of SDB among children with T2DM compared to its prevalence in non-diabetic obese children.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.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.In 6 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Sourasky Medical Center

🇮🇱

Tel-Aviv, Israel

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