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Completed

NCT Number: NCT02398877

HPA Axis Activity Due To Early Traumatic Stress and Metabolic Symptoms

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

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Key information

Conditions

Childhood Trauma Depressive Disorder Depressive Disorder, Major Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Charite University

Berlin, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stress

Other

Primary outcomes

  1. Endocrine response to stress (salivary cortisol)

    Time frame: 2 hours

    salivary cortisol

  2. glucose to oral glucose tolerance test (plasma insulin)

    Time frame: 2 hours

    plasma glucose

  3. insulin to oral glucose tolerance test (plasma insulin)

    Time frame: 2 hours

    plasma insulin

  4. cortisol to corticotropin releasing factor (salivary cortisol)

    Time frame: 3 hours

    salivary cortisol

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: Cort-Metab

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 26, 2015
Registry last updated
Mar 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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