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Addiction Remission and Addiction Transfer After Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT02757716
Recruitment Status : Active, not recruiting
First Posted : May 2, 2016
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Chiappetta, Sana Klinikum Offenbach

Brief Summary:
To evaluate addiction remission and addiction transfer after bariatric surgery.

Condition or disease Intervention/treatment Phase
Obesity Other: Questionnaire Not Applicable

Detailed Description:
A prospective study to evaluate addiction remission and addiction transfer 6, 12 and 24 month after primary surgery (sleeve gastrectomy, Roux-en-Y- gastric bypass and Omega-Loop gastric bypass) in obese patients. A questionnaire evaluating food addiction (Yale Food Scale), alcohol addiction (Audit Scale), nicotine addiction (Fagerström Scale), sport addiction, internet addiction and drug addiction (Drug Use Questionnaire) gets completed prior to surgery and 6, 12 and 24 month after surgery.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Addiction Remission and Addiction Transfer After Bariatric Surgery
Study Start Date : April 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Sleeve Gastrectomy
Obese patients who undergo sleeve gastrectomy fill in questionnaire
Other: Questionnaire
Every patient who undergo surgery will fill out a questionnaire containing validated scales concerning food, alcohol, nicotine, internet and sport addiction prior and 6, 12 and 24 month after surgery.
Roux-en-Y-Gastric Bypass
Obese patients who undergo roux-en-y-gastric bypass fill in questionnaire
Other: Questionnaire
Every patient who undergo surgery will fill out a questionnaire containing validated scales concerning food, alcohol, nicotine, internet and sport addiction prior and 6, 12 and 24 month after surgery.
Omega-Loop-Gastric Bypass
Obese patients who undergo omega-loop gastric bypass fill in questionnaire
Other: Questionnaire
Every patient who undergo surgery will fill out a questionnaire containing validated scales concerning food, alcohol, nicotine, internet and sport addiction prior and 6, 12 and 24 month after surgery.



Primary Outcome Measures :
  1. Addiction remission [ Time Frame: 12 month after surgery ]
    Addiction remission (evaluated by questionnaire) after obesity surgery


Secondary Outcome Measures :
  1. Addiction transfer [ Time Frame: 12 month after surgery ]
    Addiction transfer (evaluated by questionnaire) after obesity surgery

  2. Excess Weight Loss (EWL in %) [ Time Frame: 12 month after surgery ]
    EWL 12 month after surgery measured as a physiological parameter at 1 year Follow-Up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI > 35kg/m² and obesity related disease or BMI > 40kg/m²

Exclusion Criteria:

  • decline of study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02757716


Locations
Germany
Sana Klinikum Offenbach
Offenbach, Offenbach Am Main, Germany, 63069
Sponsors and Collaborators
Sana Klinikum Offenbach
Investigators
Study Chair: Rudolf Weiner, Prof. Sana Klinikum Offenbach, Department of Obesity and Metabolic Surgery

Publications of Results:
Responsible Party: Chiappetta, Dr. med. Sonja Chiappetta, Dr. med. Christine Stier, Sana Klinikum Offenbach
ClinicalTrials.gov Identifier: NCT02757716     History of Changes
Other Study ID Numbers: FF 146/2015
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chiappetta, Sana Klinikum Offenbach:
addiction remission
addiction transfer

Additional relevant MeSH terms:
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior