Childhood TraumaCort-MetabNCT02398877
HPA Axis Activity Due To Early Traumatic Stress and Metabolic Symptoms
A study testing stress in people with Childhood Trauma and Major Depressive Disorder, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This study evaluates the association between early trauma, depression and metabolic symptoms. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Childhood Trauma, Major Depressive Disorder
- What is being tested?
- stress
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2013to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- diagnosis of MDD and/or experience of early trauma
Who cannot join
- severe illness,
- control group: no diagnosis of MDD and experience of early trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Altered Hypothalamic-Pituitary-Adrenal Axis (HPA-Axis) Activity Due To Early Traumatic Stress and Its Relevance for Metabolic Symptoms
This study evaluates the association between early trauma, depression and metabolic symptoms.
Read the 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.
- Conditions
- Childhood Trauma, Major Depressive Disorder
- Being tested
- stress
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stressOther
| Study group | Role | What they receive |
|---|---|---|
| Depression with early trauma | Experimental | stress Receives: Other: stress |
| Depression without early trauma | Experimental | stress Receives: Other: stress |
| Healthy with early trauma | Experimental | stress Receives: Other: stress |
| Healthy without early trauma | Experimental | stress Receives: Other: stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endocrine response to stress (salivary cortisol)
salivary cortisol
Measured: 2 hours
glucose to oral glucose tolerance test (plasma insulin)
plasma glucose
Measured: 2 hours
insulin to oral glucose tolerance test (plasma insulin)
plasma insulin
Measured: 2 hours
cortisol to corticotropin releasing factor (salivary cortisol)
salivary cortisol
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startFeb 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood TraumaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katja Wingenfeld, Charite University, Berlin, Germany
- Investigators
- Katja Wingenfeld, PhD, Principal investigator, Charite University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398877
- Sponsor's protocol ID
- WI 3396/6-1
- Acronym
- Cort-Metab
- Status last verified
- Mar 2016
- First submitted
- 9 Mar 2015
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altered Hypothalamic-Pituitary-Adrenal Axis (HPA-Axis) Activity Due To Early Traumatic Stress and Its Relevance for Metabolic Symptoms
- ClinicalTrials.gov ID
- NCT02398877
- Acronym / sponsor ID
- Cort-Metab / WI 3396/6-1
- Conditions
- Childhood Trauma, Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Depression with early trauma | Experimental | Other: stressstress |
| Depression without early trauma | Experimental | Other: stressstress |
| Healthy with early trauma | Experimental | Other: stressstress |
| Healthy without early trauma | Experimental | Other: stressstress |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- diagnosis of MDD and/or experience of early trauma
Key exclusion criteria (2 listed)
- severe illness,
- control group: no diagnosis of MDD and experience of early trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stress | Other | Depression with early trauma, Depression without early trauma, Healthy with early trauma, Healthy without early trauma |
Primary outcome
Endocrine response to stress (salivary cortisol)
Time frame: 2 hours
salivary cortisol
glucose to oral glucose tolerance test (plasma insulin)
Time frame: 2 hours
plasma glucose
insulin to oral glucose tolerance test (plasma insulin)
Time frame: 2 hours
plasma insulin
cortisol to corticotropin releasing factor (salivary cortisol)
Time frame: 3 hours
salivary cortisol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katja Wingenfeld, PhD principal investigator
Charite University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stress in people with Childhood Trauma and Major Depressive Disorder, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endocrine response to stress (salivary cortisol) (time frame: 2 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2016.