HPA Axis Activity Due To Early Traumatic Stress and Metabolic Symptoms

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02398877

Acronym

Cort-Metab

Enrollment

140

Registered

2015-03-26

Start date

2013-02-28

Completion date

2016-02-29

Last updated

2016-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Trauma, Major Depressive Disorder

Brief summary

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

Detailed description

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.

Interventions

OTHERstress

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Endocrine response to stress (salivary cortisol)	2 hours	salivary cortisol
glucose to oral glucose tolerance test (plasma insulin)	2 hours	plasma glucose
insulin to oral glucose tolerance test (plasma insulin)	2 hours	plasma insulin
cortisol to corticotropin releasing factor (salivary cortisol)	3 hours	salivary cortisol

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026