- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01493583
Central Nervous Processing of Visual Food Stimuli in Severely Obese Subjects
Central Nervous Processing of Visual Food Stimuli in Severely Obese Subjects and After Roux-en Y Gastric Bypass Surgery - a FMRI Study
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Rorschach, Switzerland, 9400
- Interdisciplinary Obesity Center, Cantonal Hospital St. Gallen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Severely obese (body mass index; BMI > 35 kg/m2) women and previously severely obese women who had undergone a Roux-en Y gastric bypass operation were recruited from the Interdisciplinary Obesity Center, cantonal hospital St. Gallen (Switzerland), and the adiposity platform of the University of Tübingen.
lean control women were recruited in St. Gallen and in Tübingen
Description
Inclusion Criteria:
- women with BMI > 35kg/m2
- women, who had undergone gastric bypass surgery at least one year ago
- lean women
Exclusion Criteria:
- known psychiatric or neurological diseases
- current medication with drug acting on the central nervous system
- drugs that are known to affect eating behavior
- contraindication for the fMRI scanning, e.g. metal implants or metal containing tattoos
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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severely obese women
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Women after Roux-en Y gastric bypass surgery
Women recruited for this group had undergone Roux-en Y gastric bypass surgery at least one year before.
In this women measurement of brain activity and gastrointestinal and metabolic response took place between 13 and 106 month after surgery.
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lean women
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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brain activity
Time Frame: brain activity was measured at a single time point in all three groups; of note: women after Roux-en Y gastric bypass surgery were measured between 13 and 106 month after surgery.
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In all women brain activity was assessed by functional magnetic resonance imaging (fMRI, BOLD Method, 1.5 Tesla fMRI Scanner, Siemens, Erlangen, Germany) during the presentation of food and non-food related pictures as well as during state conditions. In all three groups, brain activity was measured at a single time point. Of note, women, who had undergone Roux-en Y gastric bypass surgery were measured between 13 and 106 month after surgery. Brain activity was not measured before surgery in this group. |
brain activity was measured at a single time point in all three groups; of note: women after Roux-en Y gastric bypass surgery were measured between 13 and 106 month after surgery.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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gastrointestinal and metabolic responses to standardized meal
Time Frame: measured at a single time point in all three groups; of note: women after Roux-en Y gastric bypass surgery were measured between 13 and 106 month after surgery at a single time point
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The gastrointestinal and metabolic responses to standardized meal were measured in the morning between 7:30 and 10:30 a.m. gastrointestinal and metabolic response were measured in all women at a single time point. Of note, women, who had undergone Roux-en Y gastric bypass surgery were measured between 13 and 106 month after surgery. Gastrointestinal and metabolic responses were not measured before surgery in this group. |
measured at a single time point in all three groups; of note: women after Roux-en Y gastric bypass surgery were measured between 13 and 106 month after surgery at a single time point
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bernd Schultes, Prof. Dr. med., Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Rorschach, Switzerland
- Principal Investigator: Niels Birbaumer, Prof. Dr., Institute of Medical Psychology and Behavioural Neurobiology, University of Tübingen, Tübingen, Germany
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EKSG09/033/2B
- 09/033/2B (Other Identifier: ID by EKSG)
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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