Addiction Remission and Addiction Transfer After Bariatric Surgery

May 13, 2019 updated by: Sonja Chiappetta, MD, Sana Klinikum Offenbach
To evaluate addiction remission and addiction transfer after bariatric surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective study to evaluate addiction remission and addiction transfer 6 and 24 months after primary surgery (sleeve gastrectomy, Roux-en-Y- gastric bypass and One anastomosis gastric bypass) in obese patients. A questionnaire evaluating food addiction (Yale Food Scale), alcohol addiction (Audit Scale), nicotine addiction (Fagerström Scale), exercise addiction (Exercise Addiction Inventory), internet addiction (ISS20) and drug addiction (Drug Use Questionnaire) gets completed prior to surgery and 6 and 24 months after surgery.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Offenbach Am Main
      • Offenbach, Offenbach Am Main, Germany, 63069
        • Sana Klinikum Offenbach

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • decline of study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 exercise and drug addiction prior, 6 months and 24 months after surgery.
Other: 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 exercise and drug addiction prior, 6 months and 24 months after surgery.
Other: One anastomosis-Gastric Bypass
Obese patients who undergo one anastomosis 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 exercise and drug addiction prior, 6 months and 24 months after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Addiction remission
Time Frame: 24 months after surgery
Addiction remission (evaluated by questionnaire) after obesity surgery
24 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Addiction transfer
Time Frame: 24 months after surgery
Addiction transfer (evaluated by questionnaire) after obesity surgery
24 months after surgery
Excess Weight Loss (EWL in %)
Time Frame: 24 months after surgery
EWL 24 months after surgery measured as a physiological parameter at 2 year Follow-Up
24 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sana Klinikum Offenbach

Investigators

  • Study Chair: Rudolf Weiner, Prof., Sana Klinikum Offenbach, Department of Obesity and Metabolic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

April 21, 2016

First Submitted That Met QC Criteria

April 29, 2016

First Posted (Estimate)

May 2, 2016

Study Record Updates

Last Update Posted (Actual)

May 15, 2019

Last Update Submitted That Met QC Criteria

May 13, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF 146/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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