This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Addiction Remission and Addiction Transfer After Bariatric Surgery

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2016 by Christine Stier, Sana Klinikum Offenbach
Sponsor:
Information provided by (Responsible Party):
Christine Stier, Sana Klinikum Offenbach
ClinicalTrials.gov Identifier:
NCT02757716
First received: April 21, 2016
Last updated: October 29, 2016
Last verified: October 2016
  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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 21, 2016
Last Updated: October 29, 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

ClinicalTrials.gov processed this record on August 18, 2017