Back to resultsAddiction Remission and Addiction Transfer After Bariatric Surgery
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Questionnaire
Sponsored by
About this trial
This is an interventional diagnostic trial for Obesity focused on measuring addiction remission, addiction transfer
Eligibility Criteria
Inclusion Criteria:
- BMI > 35kg/m² and obesity related disease or BMI > 40kg/m²
Exclusion Criteria:
- decline of study participation
Sites / Locations
- Sana Klinikum Offenbach
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Sleeve Gastrectomy
Roux-en-Y-Gastric Bypass
One anastomosis-Gastric Bypass
Arm Description
Obese patients who undergo sleeve gastrectomy fill in questionnaire
Obese patients who undergo roux-en-y-gastric bypass fill in questionnaire
Obese patients who undergo one anastomosis gastric bypass fill in questionnaire
Outcomes
Primary Outcome Measures
Addiction remission
Addiction remission (evaluated by questionnaire) after obesity surgery
Secondary Outcome Measures
Addiction transfer
Addiction transfer (evaluated by questionnaire) after obesity surgery
Excess Weight Loss (EWL in %)
EWL 24 months after surgery measured as a physiological parameter at 2 year Follow-Up
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02757716
Brief Title
Addiction Remission and Addiction Transfer After Bariatric Surgery
Official Title
Addiction Remission and Addiction Transfer After Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sana Klinikum Offenbach
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate addiction remission and addiction transfer after bariatric surgery.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
addiction remission, addiction transfer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sleeve Gastrectomy
Arm Type
Other
Arm Description
Obese patients who undergo sleeve gastrectomy fill in questionnaire
Arm Title
Roux-en-Y-Gastric Bypass
Arm Type
Other
Arm Description
Obese patients who undergo roux-en-y-gastric bypass fill in questionnaire
Arm Title
One anastomosis-Gastric Bypass
Arm Type
Other
Arm Description
Obese patients who undergo one anastomosis gastric bypass fill in questionnaire
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
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.
Primary Outcome Measure Information:
Title
Addiction remission
Description
Addiction remission (evaluated by questionnaire) after obesity surgery
Time Frame
24 months after surgery
Secondary Outcome Measure Information:
Title
Addiction transfer
Description
Addiction transfer (evaluated by questionnaire) after obesity surgery
Time Frame
24 months after surgery
Title
Excess Weight Loss (EWL in %)
Description
EWL 24 months after surgery measured as a physiological parameter at 2 year Follow-Up
Time Frame
24 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI > 35kg/m² and obesity related disease or BMI > 40kg/m²
Exclusion Criteria:
decline of study participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudolf Weiner, Prof.
Organizational Affiliation
Sana Klinikum Offenbach, Department of Obesity and Metabolic Surgery
Official's Role
Study Chair
Facility Information:
Facility Name
Sana Klinikum Offenbach
City
Offenbach
State/Province
Offenbach Am Main
ZIP/Postal Code
63069
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23374642
Citation
Volkow ND, Wang GJ, Tomasi D, Baler RD. The addictive dimensionality of obesity. Biol Psychiatry. 2013 May 1;73(9):811-8. doi: 10.1016/j.biopsych.2012.12.020. Epub 2013 Jan 29.
Results Reference
result
PubMed Identifier
24852693
Citation
Pepino MY, Stein RI, Eagon JC, Klein S. Bariatric surgery-induced weight loss causes remission of food addiction in extreme obesity. Obesity (Silver Spring). 2014 Aug;22(8):1792-8. doi: 10.1002/oby.20797. Epub 2014 May 23.
Results Reference
result
PubMed Identifier
25258356
Citation
Cuellar-Barboza AB, Frye MA, Grothe K, Prieto ML, Schneekloth TD, Loukianova LL, Hall-Flavin DK, Clark MM, Karpyak VM, Miller JD, Abulseoud OA. Change in consumption patterns for treatment-seeking patients with alcohol use disorder post-bariatric surgery. J Psychosom Res. 2015 Mar;78(3):199-204. doi: 10.1016/j.jpsychores.2014.06.019. Epub 2014 Sep 7.
Results Reference
result
PubMed Identifier
25064307
Citation
Fowler L, Ivezaj V, Saules KK. Problematic intake of high-sugar/low-fat and high glycemic index foods by bariatric patients is associated with development of post-surgical new onset substance use disorders. Eat Behav. 2014 Aug;15(3):505-8. doi: 10.1016/j.eatbeh.2014.06.009. Epub 2014 Jun 20.
Results Reference
result
PubMed Identifier
22661046
Citation
Ivezaj V, Saules KK, Wiedemann AA. "I didn't see this coming.": why are postbariatric patients in substance abuse treatment? Patients' perceptions of etiology and future recommendations. Obes Surg. 2012 Aug;22(8):1308-14. doi: 10.1007/s11695-012-0668-2.
Results Reference
result
PubMed Identifier
32369811
Citation
Chiappetta S, Stier C, Hadid MA, Malo N, Theodoridou S, Weiner R, Weiner S. Remission of Food Addiction Does Not Induce Cross-Addiction after Sleeve Gastrectomy and Gastric Bypass: A Prospective Cohort Study. Obes Facts. 2020;13(3):307-320. doi: 10.1159/000506838. Epub 2020 May 5.
Results Reference
derived
Learn more about this trial
Addiction Remission and Addiction Transfer After Bariatric Surgery
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