ObesityNCT01493583
Central Nervous Processing of Visual Food Stimuli in Severely Obese Subjects
An observational study of Obesity, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
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)… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Obesity
- How many people
- 38 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2009to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- women with BMI > 35kg/m2
- women, who had undergone gastric bypass surgery at least one year ago
- lean women
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Interdisciplinary Obesity Center, Cantonal Hospital St. Gallen
Rorschach, 9400
About this study
Official title: 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.
- 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
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| severely obese women | Not described | |
| 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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startSep 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, Competence Network for Adiposity funded by the German Federal Ministry of Education and Research (FKZ: 01GI0837) and (FKZ: 01GI0849)
- Responsible party
- Principal investigator, Bernd Schultes, Cantonal Hospital of St. Gallen
- Investigators
- Bernd Schultes, Prof. Dr. med., Principal investigator, Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Rorschach, SwitzerlandNiels Birbaumer, Prof. Dr., Principal investigator, Institute of Medical Psychology and Behavioural Neurobiology, University of Tübingen, Tübingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493583
- Sponsor's protocol ID
- EKSG09/033/2B
- Other IDs
- 09/033/2B
- Status last verified
- Mar 2013
- First submitted
- 2 Dec 2011
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Nervous Processing of Visual Food Stimuli in Severely Obese Subjects and After Roux-en Y Gastric Bypass Surgery - a FMRI Study
- ClinicalTrials.gov ID
- NCT01493583
- Acronym / sponsor ID
- EKSG09/033/2B
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, Competence Network for Adiposity funded by the German Federal Ministry of Education and Research (FKZ: 01GI0837) and (FKZ: 01GI0849)
- Study start
- Sep 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- women with BMI > 35kg/m2
- women, who had undergone gastric bypass surgery at least one year ago
- lean women
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernd Schultes, Prof. Dr. med. principal investigator
Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Rorschach, Switzerland
Niels Birbaumer, Prof. Dr. principal investigator
Institute of Medical Psychology and Behavioural Neurobiology, University of Tübingen, Tübingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.