HPA Axis Activity Due To Early Traumatic Stress and Metab... | NCT02398877

Studies
HPA Axis Activity Due To Early Traumatic Stress and Metabolic Symptoms

NCT02398877

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Mar 7, 2016Estimated

Enrollment

140Actual

Phase

Not Applicable

Conditions

Childhood Trauma
Major Depressive Disorder

Interventions

stress

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Feb 2016Actual

Completion Date

Feb 2016Actual

First Submitted Date

Mar 9, 2015

First Submission Date that Met QC Criteria

Mar 25, 2015

First Posted Date

Mar 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2016

Last Update Posted Date

Mar 7, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Katja Wingenfeld, Head: Clinical Psychology, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Depression with early trauma	Experimental	stress	Other: stress
Depression without early trauma	Experimental	stress	Other: stress
Healthy with early trauma	Experimental	stress	Other: stress
Healthy without early trauma	Experimental	stress	Other: stress

Interventions

Name	Type	Description	Arm Group Labels	Other Names
stress	Other		Depression with early trauma Depression without early trauma Healthy with early trauma Healthy without early trauma

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Katja Wingenfeld, PhD	Charite University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charite University		Berlin			Germany

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided