Central Nervous Processing of Visual Food Stimuli in Severely Obese Subjects

This study has been completed.
Sponsor:
Collaborator:
Competence Network for Adiposity funded by the German Federal Ministry of Education and Research (FKZ: 01GI0837) and (FKZ: 01GI0849)
Information provided by (Responsible Party):
Bernd Schultes, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT01493583
First received: December 2, 2011
Last updated: March 6, 2013
Last verified: March 2013
  Purpose

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
Obesity

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • 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. ]

    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 [ 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 ]

    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.



Enrollment: 38
Study Start Date: September 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493583

Locations
Switzerland
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
  More Information

No publications provided

Responsible Party: Bernd Schultes, Prof. Dr. med., Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT01493583     History of Changes
Other Study ID Numbers: EKSG09/033/2B, 09/033/2B
Study First Received: December 2, 2011
Last Updated: March 6, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by Cantonal Hospital of St. Gallen:
severely obese
Roux-en Y gastric bypass surgery (RYGB)
brain activity by fMRI
visual presentation of food and non-food-related pictures

ClinicalTrials.gov processed this record on September 22, 2014