Clinical trial NCT01493583: Central Nervous Processing of Visual Food Stimuli in Severely Obese Subjects
Official title: Central Nervous Processing of Visual Food Stimuli in Severely Obese Subjects and After Roux-en Y Gastric Bypass Surgery - a FMRI Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: severely obese
Roux-en Y gastric bypass surgery (RYGB)
brain activity by fMRI
visual presentation of food and non-food-related pictures
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: Competence Network for Adiposity funded by the German Federal Ministry of Education and Research (FKZ: 01GI0837) and (FKZ: 01GI0849)
First posted: 2011-12-16
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief summary: Recent evidence has pointed to distinct alterations of brain functions in obese subjects some of which may even be causative for their obesity. The objective of this study was to examine food and non food related alterations in brain functions after excessive weight loss due to Roux-en Y gastric bypass surgery (RYGB), one of the most successful therapeutic approaches for long lasting weight loss. The investigators hypothesized that obese as compared with lean women show an altered activation pattern in the brain areas involved in the homeostatic regulation of eating behavior, i.e. the hypothalamus, in reward-related brain areas, such as the orbital frontal cortex (OFC) and the striatum as well as in prefrontal inhibitory control areas. Furthermore, the investigators hypothesized that women who had undergone a RYGB operation show a brain activity pattern that more closely mimics that of lean than severely obese women. In a supplementary test the investigators will assess gastrointestinal and metabolic response to a standardized meal in order to elucidate putative correlation of these responses with the results of fMRI scannings.


Eligibility criteria: 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

Primary outcomes:
measure: brain activity
timeFrame: 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.
Secondary outcomes:
measure: gastrointestinal and metabolic responses to standardized meal
timeFrame: 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
Other outcomes:
Locations:
city: Rorschach
country: Switzerland
facility: Interdisciplinary Obesity Center, Cantonal Hospital St. Gallen
Study officials:
affiliation: Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Rorschach, Switzerland
name: Bernd Schultes, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Medical Psychology and Behavioural Neurobiology, University of Tübingen, Tübingen, Germany
name: Niels Birbaumer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: