Trial document




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  DRKS00012495

Trial Description

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Title

Impact of bariatric surgery on neural food processing and cognition – an fMRI study

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The study seeks to investigate longitudinal changes in neuronal food-processing and cogntion associated with bariatric surgery.

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Brief Summary in Scientific Language

Neuronal food processing and cognition (e.g., executive functioning) is known to be altered in obesity. The current study investigates whether the altered neuronal circuits are affected by a bypass surgery. The main measurement will be functional magnetresonancetomographie (fMRI) with a follow up date one year after surgery.

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Organizational Data

  •   DRKS00012495
  •   2018/06/06
  •   [---]*
  •   yes
  •   Approved
  •   2017-073, Medizinische Ethikkommission der Carl von Ossietzky Universität Oldenburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E66 -  Obesity
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Interventions/Observational Groups

  •   Obese patients that fullfil the criteria for receiving a gastric-bypass surgery
  •   healthy, normal-weighted control group
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

1. Neuronal food porcessing - presentation via food-images - measured with fMRI
2. working memory - presentation with 2-back-task - measured with fMRI
3. functional connectivity - measurement at rest with fMRI

All measurements will be done twice (pre-surgery and one year post-surgery)

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Secondary Outcome

1. hormonal status (GLP-1, PYY)
2. working memory results from the 2-back-task (hits, erros, false postives)
3. questionnaire data (Freiburg Personality Inventory, structured clinical interview, questionnaire if eating behavior, Beck Depression Inventory, Behavioral Inhibtion System, Wender-Utah-rating scales, Conners' adult ADHD self-rating scales)

All measurements will be done twice (pre-surgery and one year post-surgery)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2018/07/01
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   60   Years
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Additional Inclusion Criteria

Age: 18-60
BMI: >35kg/m2 (Obesity-Group); <25kg/m2 (Control-Group)
Gender: Female
Participants in the obesity group will receive RYGB operation

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Exclusion Criteria

Substance abuse
Smoking
Psychiatric disorders (except anxiety)
History of eating disorder
Psychopharmacological treatment
Pregnancy
Claustrophobia
Neurological disorders

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Addresses

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    • Fakultät VI - Medizin und Gesundheitswissenschaften Carl-von Ossietzky Universität Oldenburg
    • Mr.  Dr. med  Peter  Sörös 
    • Heiligengeisthöfe 4, Postfach 2503
    • 26111  Oldenburg
    • Germany
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    • Medizinischer Campus Universität Oldenburg Fakultät für Medizin und Gesundheitswissenschaften Universitätsklinik für Psychiatrie und Psychotherapie Karl-Jaspers-Klinik
    • Mr.  M.Sc.  Marcel  Schulze 
    • Hermann-Ehlers-Straße 7
    • 26160  Bad Zwischenahn
    • Germany
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    • Medizinischer Campus Universität Oldenburg Fakultät für Medizin und Gesundheitswissenschaften Universitätsklinik für Psychiatrie und Psychotherapie Karl-Jaspers-Klinik
    • Mr.  M.Sc.  Marcel  Schulze 
    • Herrmann-Ehlers-Straße 7
    • 26160  Bad Zwischenahn
    • Germany
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Sources of Monetary or Material Support

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    • Medizinischer Campus Universität Oldenburg Fakultät für Medizin und Gesundheitswissenschaften Universitätsklinik für Psychiatrie und Psychotherapie Karl-Jaspers-Klinik
    • Mr.  M.Sc.  Marcel  Schulze 
    • Hermann-Ehlers-Straße 7
    • 26160  Bad Zwischenahn
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.