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Completed

NCT Number: NCT01493583

Central Nervous Processing of Visual Food Stimuli in Severely Obese Subjects

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Interdisciplinary Obesity Center, Cantonal Hospital St. Gallen

Rorschach, 9400, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 16, 2011
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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