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临床试验/NCT02398877
NCT02398877已完成不适用

Altered Hypothalamic-Pituitary-Adrenal Axis (HPA-Axis) Activity Due To Early Traumatic Stress and Its Relevance for Metabolic Symptoms

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
1
主要终点
insulin to oral glucose tolerance test (plasma insulin)

研究概览

简要总结

This study evaluates the association between early trauma, depression and metabolic symptoms.

详细描述

Early traumatic stress is associated with alterations of the hypothalamic-pituitary-adrenal axis (HPA-axis) indicated by an increased response to stress, a diminished negative feedback and alterations in expression of glucocorticoid receptors. Patients with a history of childhood trauma are more likely to develop metabolic disorders such as diabetes mellitus type 2 or metabolic syndrome.

The investigators will examine participants with and without early life stress and with and without major depression. The investigators assume that traumatized study participants (1) show an increased endocrine stress reaction to psychosocial stress, (2) display an altered sensitivity of GR, and (3) therefore suffer from an adverse cardiovascular risk profile in comparison to not-traumatized participants.

The investigators study will increase current knowledge on possible sequel of early traumatic stress. The results will lead to a more comprehensive understanding of stress-related eating behaviour and its implications.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • diagnosis of MDD and/or experience of early trauma

排除标准

  • severe illness,
  • control group: no diagnosis of MDD and experience of early trauma

结局指标

主要结局

insulin to oral glucose tolerance test (plasma insulin)

时间窗: 2 hours

plasma insulin

cortisol to corticotropin releasing factor (salivary cortisol)

时间窗: 3 hours

salivary cortisol

Endocrine response to stress (salivary cortisol)

时间窗: 2 hours

salivary cortisol

glucose to oral glucose tolerance test (plasma insulin)

时间窗: 2 hours

plasma glucose

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katja Wingenfeld

Head: Clinical Psychology

Charite University, Berlin, Germany

研究点 (1)

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