HPA Axis Activity Due To Early Traumatic Stress and Metabolic Symptoms

Not Applicable

Completed

• Conditions: Childhood Trauma; Major Depressive Disorder
• Interventions: Other: stress

• Registration Number: NCT02398877
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2015-03-09
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-26
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-04
• Last Update Posted: 2016-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Depression without early trauma	stress	stress
Depression with early trauma	stress	stress
Healthy with early trauma	stress	stress
Healthy without early trauma	stress	stress

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Charite University; 🇩🇪 Berlin, Germany