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Addiction Remission and Addiction Transfer After Bariatric Surgery

This study is currently recruiting participants.
Verified October 2016 by Christine Stier, Sana Klinikum Offenbach
Sponsor:
ClinicalTrials.gov Identifier:
NCT02757716
First Posted: May 2, 2016
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Christine Stier, Sana Klinikum Offenbach
  Purpose
To evaluate addiction remission and addiction transfer after bariatric surgery.

Condition Intervention
Obesity Other: Questionnaire

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Addiction Remission and Addiction Transfer After Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by Christine Stier, Sana Klinikum Offenbach:

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


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

  • 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


Estimated Enrollment: 100
Study Start Date: April 2016
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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


Contacts
Contact: Sonja Chiappetta, MD 0049 69 8405 1706 sonja.chiappetta@sana.de
Contact: Christine Stier, MD 0049 69 8405 1733 christine.stier@sana.de

Locations
Germany
Sana Klinikum Offenbach Recruiting
Offenbach, Offenbach am Main, Germany, 63069
Contact: Sonja Chiappetta, MD    0049 69 8405 1706    sonja.chiappetta@sana.de   
Contact: Christine Stier, MD    0049 69 8405 1733    christine.stier@sana.de   
Sponsors and Collaborators
Sana Klinikum Offenbach
Investigators
Study Chair: Rudolf Weiner, Prof. Sana Klinikum Offenbach, Department of Obesity and Metabolic Surgery
  More Information

Publications:
Responsible Party: Christine Stier, 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 Submitted: April 21, 2016
First Posted: May 2, 2016
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Christine Stier, Sana Klinikum Offenbach:
addiction remission
addiction transfer

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