NCT02757716

Brief Summary

To evaluate addiction remission and addiction transfer after bariatric surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 2, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

2.8 years

First QC Date

April 21, 2016

Last Update Submit

May 13, 2019

Conditions

Obesity

Keywords

addiction remissionaddiction transfer

Outcome Measures

Primary Outcomes (1)

  • Addiction remission

    Addiction remission (evaluated by questionnaire) after obesity surgery

    24 months after surgery

Secondary Outcomes (2)

  • Addiction transfer

    24 months after surgery

  • Excess Weight Loss (EWL in %)

    24 months after surgery

Study Arms (3)

Sleeve Gastrectomy

OTHER

Obese patients who undergo sleeve gastrectomy fill in questionnaire

Other: Questionnaire

Roux-en-Y-Gastric Bypass

OTHER

Obese patients who undergo roux-en-y-gastric bypass fill in questionnaire

Other: Questionnaire

One anastomosis-Gastric Bypass

OTHER

Obese patients who undergo one anastomosis gastric bypass fill in questionnaire

Other: Questionnaire

Interventions

QuestionnaireOTHER

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.

One anastomosis-Gastric BypassRoux-en-Y-Gastric BypassSleeve Gastrectomy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • decline of study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sana Klinikum Offenbach

Offenbach, Offenbach Am Main, 63069, Germany

Location

Related Publications (6)

  • 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.

    PMID: 23374642RESULT

  • 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.

    PMID: 24852693RESULT

  • 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.

    PMID: 25258356RESULT

  • 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.

    PMID: 25064307RESULT

  • 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.

    PMID: 22661046RESULT

  • 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.

    PMID: 32369811DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Rudolf Weiner, Prof.

    Sana Klinikum Offenbach, Department of Obesity and Metabolic Surgery

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Sonja Chiappetta, Dr. med. Christine Stier

Study Record Dates

First Submitted

April 21, 2016

First Posted

May 2, 2016

Study Start

April 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

May 15, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)