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Central Nervous Processing of Visual Food Stimuli in Severely Obese Subjects

6. mars 2013 oppdatert av: Bernd Schultes, Cantonal Hospital of St. Gallen

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

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.

Studieoversikt

Status

Fullført

Forhold

Overvekt

Studietype

Observasjonsmessig

Registrering (Faktiske)

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Sveits
- - Rorschach, Sveits, 9400
    - Interdisciplinary Obesity Center, Cantonal Hospital St. Gallen

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
brain activity Tidsramme: 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.	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.

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
gastrointestinal and metabolic responses to standardized meal Tidsramme: 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.	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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Cantonal Hospital of St. Gallen

Samarbeidspartnere

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

Etterforskere

Hovedetterforsker: Bernd Schultes, Prof. Dr. med., Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Rorschach, Switzerland
Hovedetterforsker: Niels Birbaumer, Prof. Dr., Institute of Medical Psychology and Behavioural Neurobiology, University of Tübingen, Tübingen, Germany

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2009

Primær fullføring (Faktiske)

1. desember 2012

Studiet fullført (Faktiske)

1. desember 2012

Datoer for studieregistrering

Først innsendt

2. desember 2011

Først innsendt som oppfylte QC-kriteriene

14. desember 2011

Først lagt ut (Anslag)

16. desember 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

7. mars 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. mars 2013

Sist bekreftet

1. mars 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

EKSG09/033/2B
09/033/2B (Annen identifikator: ID by EKSG)

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Central Nervous Processing of Visual Food Stimuli in Severely Obese Subjects