Trial document




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  DRKS00012419

Trial Description

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Title

Childhood Escape – Late Life Outcome (CELLO): metabolic, psychiatric, endocrinological and epigenetic consequences of escape from East Prussia in affected subjects and their offspring

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Trial Acronym

CELLO

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URL of the Trial

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Brief Summary in Lay Language

Adverse experiences in childhood may increase the risk for the onset of specific adult diseases. This may also be true for traumatic experiences of the parents.
The CELLO study will investigate subjects with a history of escape and displacement in World War II from East prussia. We will study both, subjects with individual as well as parental experience of displacement. Also, we will study a control group without the experience of displacement. In a first step, we will assess the lifetime risk for specific disorders using interviews and questionnaires: Diabetes mellitus, adiposity, depression, dysregulation of stress hormones. In case there is a differential risk for the above-mentioned disorders, we will try to disentangle the biological cause of the relationship by using modern biochemical approaches. Specifically, we will study epigenetic features. These marks on the genome may modulate the likelyhood of usage of specific genes and, thereby, affect the risk for specific disorders.

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Brief Summary in Scientific Language

Background: Early trauma or trauma in pregancy may increase the risk for adult onset of type 2 Diabetes mellitus, adiposity or depression. Also, it has been reportet that early life trauma may lead to epigenetic changes leading to differential gene expression, which may explain differential physiology, including stress response and behavior in adulthood. Negative effects of trauma on health in the offspring generation has also been described.
Hypothesis: this study tests the hypothesis that severe trauma, both transgenerationally in the parent generation as well as in early life in the index Population, leads to an increased risk for Diabetes mellitus tpe 2, adiposity, depression or to differential regulaton of the activity of the stress-responsive hypothalamus-pituitary-adrenal (HPA) System. If this hypothesis is confirmed, we will test, in a second step, the hypothesis that differential epigenetic regulation is induced by parental (transgenerationally) or early life trauma.
Population: In order to test these hypotheses, we will study a group of World War II refugess from East Prussia or their offspring. We will compare these groups with a control group without a refugee history in the index or parent population.

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Organizational Data

  •   DRKS00012419
  •   2017/05/23
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  •   yes
  •   Approved
  •   2017-538N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   F33 -  Recurrent depressive disorder
  •   E11 -  Type 2 diabetes mellitus
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Interventions/Observational Groups

  •   subjects with early life trauma (East Prussia refugees): using questionnaires, interviews and saliva samples, we will estimate the lifetime risk for diabetes, depression, adiposity and dysregulation of the stress hormone cortisol. Eventually, we will study the epigenetic causes of a modulated risk of the above-mentioned conditions.
  •   subjects with parental trauma (East Prussia refugees): using questionnaires, interviews and saliva samples, we will estimate the lifetime risk for diabetes, depression, adiposity and dysregulation of the stress hormone cortisol. Eventually, we will study the epigenetic causes of a modulated risk of the above-mentioned conditions.
  •   control subjects without own or parental refugee experience: using questionnaires, interviews and saliva samples, we will estimate the lifetime risk for diabetes, depression, adiposity and dysregulation of the stress hormone cortisol. Eventually, we will study the epigenetic causes of a modulated risk of the above-mentioned conditions.
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

life time prevalence of type 2 Diabetes mellitus (questionnaire FindRisk, medication), adiposity (Body mass index), depression (questions of SKID Interview), HPA Dysregulation (diurnal cortisol profile in saliva)

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Secondary Outcome

epigenetic study using Infinium HumanMethylation450 BeadChip in order to test association of specific differential epigenetic modification in subjects with traumatic displacement experience and the above-mentioned phenotypes.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2017/05/24
  •   800
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   52   Years
  •   90   Years
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Additional Inclusion Criteria

own or parental refugee experience

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Exclusion Criteria

impaired ability to consent

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. (apl) Dr. med.  Michael  Deuschle 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. (apl) Dr. med.  Michael  Deuschle 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. (apl) Dr. med.  Michael  Deuschle 
    • J5
    • 68159  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. (apl) Dr. med.  Michael  Deuschle 
    • J5
    • 68159  Mannheim
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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