NCT02494375Unknown不适用
Sleep and Glycemic Control in Type 1 Diabetic Children
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Association between HbA1c and sleep characteristics
研究概览
简要总结
The primary goal of the study is to determine whether insufficient sleep is associated with poor glycemic control in type 1 diabetic children. Secondary goals aim to determine whether salivary amylase could be an easily accessible and non-invasive biomarker of sleep loss and somnolence, and whether insufficient sleep is linked to body composition. Sleep characteristics, glycemic control, salivary amylase and body composition will be assessed 3 times, at 3-4 months intervals, in 82 type 1 diabetic children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male type 1 diabetic children and adolescents who are followed at the Woman, Mother and Child's Hospital (Hôpital Femme Mère Enfant : HFME) of Bron, France.
排除标准
- •Refusal of consent of the parents or the child or the adolescent
- •Pregnancy
- •Concomitant pathology that severly impacts sleep
- •Implanted electrical stimulation device
- •Diagnosis of type 1 diabetes <1 year
结局指标
主要结局
Association between HbA1c and sleep characteristics
时间窗: Month 3, Month 6 and Month 9
次要结局
- Body composition (BMI fat and lean mass percentage)(Month 3, Month 6 and Month 9)
- Daily salivary amylase variation (Enzyme Activity)(Month 3, Month 6 and Month 9)
- Glucose levels(Month 3, Month 6 and Month 9)
研究者
研究点 (2)
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