Central Nervous Processing of Visual Food Stimuli in Severely Obese Subjects

NCT ID: NCT01493583

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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severely obese women

No interventions assigned to this group

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.

No interventions assigned to this group

lean women

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role lead

Responsible Party

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Bernd Schultes

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bernd Schultes, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Rorschach, Switzerland

Niels Birbaumer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Institute of Medical Psychology and Behavioural Neurobiology, University of Tübingen, Tübingen, Germany

Locations

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Interdisciplinary Obesity Center, Cantonal Hospital St. Gallen

Rorschach, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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09/033/2B

Identifier Type: OTHER

Identifier Source: secondary_id

EKSG09/033/2B

Identifier Type: -

Identifier Source: org_study_id

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