NCT02377583已完成不适用
Hypothalamo-pituitary Adrenal Axis Activity: Relation With Neuropsychological Consequences in Type 1 Diabetes in Childhood. The CORTICODIAB Study
University Hospital, Bordeaux6 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2012年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 6
- 主要终点
- Mean of nocturnal urinary free cortisol during 5 days.
研究概览
简要总结
The general objective is to precise the role of HPA axis activity in neuropsychological consequences of type 1 diabetes. The investigators hypothesize that hyperactivity of HPA axis is associated with higher scores of depression and changes in hippocampal volume and mean diffusion.
详细描述
- Background: Type 1 diabetes could be associated with hyperactivity of hypothalamo-pituitary adrenal (HPA) axis. Type 1 diabetes is associated with higher frequency neuropsychological consequences as mood disorders and structural changes in brain, particularly in hippocampus.
- Purpose: To describe the association between HPA axis activity and anxiety and depression scores in 6-12 year's old diabetes children.
- Abstract: The general objective is to precise the role of HPA axis activity in neuropsychological consequences of type 1 diabetes. The investigators hypothesize that hyperactivity of HPA axis is associated with higher scores of depression and changes in hippocampal volume and mean diffusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diabetic group:
- •diabetes for 1 year
- •6-12 year's old
- •included in ISIS-DIAB protocol.
- •Control group:
- •brother or sister of a diabetic children
- •6-12 year's old.
排除标准
- •Per os or inhaled corticoid in the previous month of inclusion.
- •Acute infectious disease in the previous week of inclusion.
- •Other chronic disease than diabetes type
- •Psychiatric disorders or psychiatric treatment.
结局指标
主要结局
Mean of nocturnal urinary free cortisol during 5 days.
时间窗: During 5 days after the inclusion
Depression (CDI) score
时间窗: At the inclusion
次要结局
- Polymorphisms of genes involved in HPA axis activity(At the inclusion)
- Anxiety (STAI) score(At the inclusion)
- Hippocampal volume and mean diffusion(At the inclusion)
- Mean of awakening salivary cortisol and mean of nocturnal urinary cortisol metabolites during 5 days(During 5 days after the inclusion)
- Profiles of glucocorticoid sensitive genes expressed in peripheral blood mononuclear cells.(At the inclusion)
研究者
研究点 (6)
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