HPA Axis Activity Due To Early Traumatic Stress and Metabolic Symptoms

Major Depressive Disorder Clinical Trial

— Cort-Metab  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02398877
• Other study ID #: WI 3396/6-1
• Status: Completed
• Phase: N/A
• First received: March 9, 2015
• Last updated: March 4, 2016
• Start date: February 2013
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Childhood Trauma
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Other:
• stress

Locations

Country	Name	City	State
Germany	Charite University	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endocrine response to stress (salivary cortisol)	salivary cortisol	2 hours	No
Primary	glucose to oral glucose tolerance test (plasma insulin)	plasma glucose	2 hours	No
Primary	insulin to oral glucose tolerance test (plasma insulin)	plasma insulin	2 hours	No
Primary	cortisol to corticotropin releasing factor (salivary cortisol)	salivary cortisol	3 hours	No