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HPA Axis Activity Due To Early Traumatic Stress and Metabolic Symptoms (Cort-Metab)

Primary Purpose

Childhood Trauma, Major Depressive Disorder

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

stress

About this trial

This is an interventional basic science trial for Childhood Trauma

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Charite University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Depression with early trauma

Depression without early trauma

Healthy with early trauma

Healthy without early trauma

Arm Description

stress

Outcomes

Primary Outcome Measures

Endocrine response to stress (salivary cortisol)

salivary cortisol

glucose to oral glucose tolerance test (plasma insulin)

plasma glucose

insulin to oral glucose tolerance test (plasma insulin)

plasma insulin

cortisol to corticotropin releasing factor (salivary cortisol)

salivary cortisol

Secondary Outcome Measures

Full Information

NCT ID

NCT02398877

First Posted

March 9, 2015

Last Updated

March 4, 2016

Sponsor

Charite University, Berlin, Germany

1. Study Identification

Unique Protocol Identification Number

NCT02398877

Brief Title

HPA Axis Activity Due To Early Traumatic Stress and Metabolic Symptoms

Acronym

Cort-Metab

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Childhood Trauma, Major Depressive Disorder

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Depression with early trauma

Arm Type

Experimental

Arm Description

stress

Arm Title

Depression without early trauma

Arm Type

Experimental

Arm Description

stress

Arm Title

Healthy with early trauma

Arm Type

Experimental

Arm Description

stress

Arm Title

Healthy without early trauma

Arm Type

Experimental

Arm Description

stress

Intervention Type

Other

Intervention Name(s)

stress

Primary Outcome Measure Information:

Title

Endocrine response to stress (salivary cortisol)

Description

salivary cortisol

Time Frame

2 hours

Title

glucose to oral glucose tolerance test (plasma insulin)

Description

plasma glucose

Time Frame

2 hours

Title

insulin to oral glucose tolerance test (plasma insulin)

Description

plasma insulin

Time Frame

2 hours

Title

cortisol to corticotropin releasing factor (salivary cortisol)

Description

salivary cortisol

Time Frame

3 hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Katja Wingenfeld, PhD

Organizational Affiliation

Charite University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Charite University

City

Berlin

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

HPA Axis Activity Due To Early Traumatic Stress and Metabolic Symptoms

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