HPA Axis Activity Due To Early Traumatic Stress and Metabolic Symptoms (Cort-Metab)
Altered Hypothalamic-Pituitary-Adrenal Axis (HPA-Axis) Activity Due To Early Traumatic Stress and Its Relevance for Metabolic Symptoms
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Berlin、德国
- Charite University
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- diagnosis of MDD and/or experience of early trauma
Exclusion Criteria:
- severe illness,
- control group: no diagnosis of MDD and experience of early trauma
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Depression with early trauma
stress
|
|
|
实验性的:Depression without early trauma
stress
|
|
|
实验性的:Healthy with early trauma
stress
|
|
|
实验性的:Healthy without early trauma
stress
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Endocrine response to stress (salivary cortisol)
大体时间:2 hours
|
salivary cortisol
|
2 hours
|
|
glucose to oral glucose tolerance test (plasma insulin)
大体时间:2 hours
|
plasma glucose
|
2 hours
|
|
insulin to oral glucose tolerance test (plasma insulin)
大体时间:2 hours
|
plasma insulin
|
2 hours
|
|
cortisol to corticotropin releasing factor (salivary cortisol)
大体时间:3 hours
|
salivary cortisol
|
3 hours
|
合作者和调查者
调查人员
- 首席研究员:Katja Wingenfeld, PhD、Charite University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.