AdiposityNCT01900483
Brain Functions in Patients Before and After Bariatric Surgery
An observational study of Adiposity, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The project will specifically focus on the examination of the influence of substantial weight loss due to bariatric surgery on brain functions. Our hypothesis is that substantial weight loss after Bariatric Surgery (BS) is also accompanied by changes in the balance of reward and inhibitory networks in diabetic… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Adiposity
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento Aug 2014
- 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 25 to 65 years
- All sexes
- Adult, Older adult
Study population: volunteers pre and post bariatric surgery
Who may be able to join
- bariatric surgery in the past or in the future
- diabetes (at least before surgery)
Who cannot join
- fMRI contraindications
- claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
The project will specifically focus on the examination of the influence of substantial weight loss due to bariatric surgery on brain functions. Our hypothesis is that substantial weight loss after Bariatric Surgery (BS) is also accompanied by changes in the balance of reward and inhibitory networks in diabetic subjects. Therefore the investigators will conduct a functional magnetic resonance imaging (fMRI) study investigating functional measures.
- Conditions
- Adiposity
- 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 |
|---|---|---|
| pre bariatric surgery | Not described | |
| post bariatric surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential brain functions
brain functions will be measured by blood oxygen level dependent effects
Measured: at least 6 months after bariatric surgery (experimental group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Primary completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdiposityStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabine Frank, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900483
- Sponsor's protocol ID
- BSD
- Status last verified
- Nov 2015
- First submitted
- 8 Jul 2013
- Last updated
- 10 Nov 2015
- Results posted
- No
Publications
Frank S, Heinze JM, Fritsche A, Linder K, von Feilitzsch M, Konigsrainer A, Haring HU, Veit R, Preissl H. Neuronal Food Reward Activity in Patients With Type 2 Diabetes With Improved Glycemic Control After Bariatric Surgery. Diabetes Care. 2016 Aug;39(8):1311-7. doi: 10.2337/dc16-0094. Epub 2016 Jun 12.
PubMed 27293200
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Functions in Patients Before and After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01900483
- Acronym / sponsor ID
- BSD
- Conditions
- Adiposity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Primary completion
- Aug 2014 (actual)
- First posted
- 16 Jul 2013 (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.
The project will specifically focus on the examination of the influence of substantial weight loss due to bariatric surgery on brain functions. Our hypothesis is that substantial weight loss after Bariatric Surgery (BS) is also accompanied by changes in the balance of reward and inhibitory networks in diabetic subjects. Therefore the investigators will conduct a functional magnetic resonance imaging (fMRI) study investigating functional measures.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre bariatric surgery | – | – |
| post bariatric surgery | – | – |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- volunteers pre and post bariatric surgery
Key inclusion criteria (2 listed)
- bariatric surgery in the past or in the future
- diabetes (at least before surgery)
Key exclusion criteria (2 listed)
- fMRI contraindications
- claustrophobia
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
Differential brain functions
Time frame: at least 6 months after bariatric surgery (experimental group)
brain functions will be measured by blood oxygen level dependent effects
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 10 Nov 2015.
- Derived from this study: PubMed 27293200Frank S, Heinze JM, Fritsche A, Linder K, von Feilitzsch M, Konigsrainer A, Haring HU, Veit R, Preissl H. Neuronal Food Reward Activity in Patients With Type 2 Diabetes With Improved Glycemic Control After Bariatric Surgery. Diabetes Care. 2016 Aug;39(8):1311-7. doi: 10.2337/dc16-0094. Epub 2016 Jun 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Adiposity, run by University Hospital Tuebingen at 1 site in Germany.
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 2 inclusion and 2 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 10 Nov 2015. 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 Germany. 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?
Differential brain functions (time frame: at least 6 months after bariatric surgery (experimental group)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01900483, which also lists 1 linked publication.
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 10 Nov 2015.