Central Nervous Processing of Visual Food Stimuli in Severely Obese Subjects

Sponsor

Cantonal Hospital of St. Gallen (Other)

Overall Status

Completed

CT.gov ID

NCT01493583

Collaborator

Competence Network for Adiposity funded by the German Federal Ministry of Education and Research (FKZ: 01GI0837) and (FKZ: 01GI0849) (Other)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity

Study Design

Study Type:

Observational

Actual Enrollment :

38 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

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 Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
severely obese women
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.
lean women

Outcome Measures

Primary Outcome Measures

brain activity [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.]
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.

Secondary Outcome Measures

gastrointestinal and metabolic responses to standardized meal [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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Interdisciplinary Obesity Center, Cantonal Hospital St. Gallen	Rorschach		Switzerland	9400

Sponsors and Collaborators

Cantonal Hospital of St. Gallen
Competence Network for Adiposity funded by the German Federal Ministry of Education and Research (FKZ: 01GI0837) and (FKZ: 01GI0849)

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