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临床试验/NCT02037100
NCT02037100Unknown不适用

Sleep Disordered Breathing and Impaired Glucose Homeostasis in Obese Children

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Investigate the prevalence and severity of SDB among children with T2DM compared to its prevalence in non-diabetic obese children.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
6 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosed with T2DM

排除标准

  • 未提供

结局指标

主要结局

Investigate the prevalence and severity of SDB among children with T2DM compared to its prevalence in non-diabetic obese children.

时间窗: 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.

时间窗: 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.

时间窗: In 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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