Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00009900

Trial Description

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Title

Addiction Transfer following Bariatric Surgery

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Trial Acronym

TransAddict-BS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The study investigates potential cross-addiction following bariatric surgery.

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Brief Summary in Scientific Language

The longitudinal study investigates the relationship between bariatric surgery and cross-addiction. It aimes at examining if obese patients with food addiction experience a transfer from food addiction to other nonfood-related addictive behaviors following bariatric surgery. Additional research questions address the impact of weight loss or weight course, obesity-related somatic conditions, and general psychopathology on addictive behaviors.
Hypotheses:
(1) Eating disorder and food addiction symptoms are reduced after bariatric surgery.
(2) Symptoms of alcohol use disorder, nicotin use disorder, and behavioral addictions (exercise dependence, hypersexuality, Internet addiction, pathological buying, gambling disorder) are increased following bariatric surgery.
(3) The reduction of eating disorder and food addiction symptoms is correlated with an increase in alcohol use, nicotine use, and behavioral addictions.
The study will include 200 adult patients who will be assessed prior surgery, as well as 6 and 12 months after Roux-en-Y-surgery. All patients will provide self-reported sociodemogarphic information and will answer standardized questionnaires. Weight and height will be objectively measured.

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Organizational Data

  •   DRKS00009900
  •   2016/01/19
  •   [---]*
  •   yes
  •   Approved
  •   2618-2015, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

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

  •   E66 -  Obesity
  •   F10.2 -  Mental and behavioural disorders due to use of alcohol; Dependence syndrome
  •   F17.2 -  Mental and behavioural disorders due to use of tobacco; Dependence syndrome
  •   F50 -  Eating disorders
  •   F63.0 -  Pathological gambling
  •   F63.9 -  Habit and impulse disorder, unspecified
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Interventions/Observational Groups

  •   The study includes adult patients with extreme obesity who will be assessed prior, as well as 6 and 12 months following Roux-en-Y-gastric bypass surgery using standardized questionnaires.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Standardized questionnaires concerning addictive behaviors will be adminsiterd prior, as well as 6 and 12 months following bariatric surgery.

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Secondary Outcome

Patient Health Questionnaire (PHQ), and Barratt Impulsiveness Scale (BIS-15) will be adminsiterd prior, as well as 6 and 12 months following bariatric surgery.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2015/09/01
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

Bariatric surgery candidates (Roux-en-Y-gastric Bypass surgery)

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Exclusion Criteria

Insufficient German language skills, acute psychosis, intellectual retardation

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Addresses

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    • Medizinische Hochschule Hannover Klinik für Psychosomatik und Psychotherapie
    • Ms.  Prof. Dr. med. Dr. phil.  Astrid  Müller 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Herzogin Elisabeth Hospital Adipositaszentrum
    • Mr.  Dr. med.  Hinrich  Köhler 
    • Leipziger Str. 24
    • 38124  Braunschweig
    • Germany
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    • KRH Klinikum Neustadt
    • Mr.  Prof. Dr. med.  Julian  Mall 
    • Haltenhoffstr. 41
    • 30167  Hannover
    • Germany
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    • Medizinische Hochschule Hannover Klinik für Psychosomatik und Psychotherapie
    • Ms.  Prof. Dr. med. Dr. phil.  Astrid  Müller 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover Klinik für Psychosomatik und Psychotherapie
    • Ms.  Prof. Dr. med. Dr. phil.  Astrid  Müller 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Institut Danone Ernährung für Gesundheit e.V.
    • Richard-Reitzner-Allee 1
    • 85540   Haar
    • Germany
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    •   089627333 89
    •   08962733659
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2019/05/30
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* This entry means the parameter is not applicable or has not been set.