Central Nervous Processing of Visual Food Stimuli in Severely Obese Subjects

NCT01493583 | Completed

• 2 other identifiers: EKSG09/033/2B09/033/2B
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• brain activity

  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.

Secondary Outcomes (1)

• 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

Study Arms (3)

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 Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• women with BMI \> 35kg/m2
• women, who had undergone gastric bypass surgery at least one year ago
• lean women

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Interdisciplinary Obesity Center, Cantonal Hospital St. Gallen

Rorschach, 9400, Switzerland

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: December 2, 2011
• First Posted: December 16, 2011
• Study Start: September 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 12, 2025

Record last verified: 2013-03

Locations

CH (1)