Central Nervous Processing of Visual Food Stimuli in Severely Obese Subjects

Obesity Clinical Trial

Official title:

Central Nervous Processing of Visual Food Stimuli in Severely Obese Subjects and After Roux-en Y Gastric Bypass Surgery - a fMRI Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01493583
• Other study ID #: EKSG09/033/2B
• Secondary ID: 09/033/2B
• Status: Completed
• Phase: N/A
• First received: December 2, 2011
• Last updated: March 6, 2013
• Start date: September 2009
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
Switzerland	Interdisciplinary Obesity Center, Cantonal Hospital St. Gallen	Rorschach

Sponsors (2)

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

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	gastrointestinal and metabolic responses to standardized meal	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