ObesityNCT01815216
Effect of Gastric Bypass Surgery on Brain Responses
A study testing Bariatric surgery, Brain activity in resting state and Memory performance in people with Obesity and Hormone Responses, run by Uppsala University at 1 site in Sweden.
Trial summary
After obesity surgery gastric bypass (GBP) patients usually lose more than 50% of its former preponderance in relative short time (~ 2 years). But knowledge of the underlying biological mechanisms of decline in body weight is still inadequate. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Obesity, Hormone Responses, Cognitive Health
- What is being tested?
- Bariatric surgery, Brain activity in resting state and Memory performance
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2013to Dec 2016
- Phase
- Interventional
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female
- right-handed
- scheduled for bariatric surgery in the Academic Hospital of Uppsala, Sweden
Who cannot join
- undergone more than one bariatric surgery
- suffer from mental disorders (depression, phobias, etc.) that can not be controlled with treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Bariatric Surgery on Impulsivity and Attentional Bias to Food Cues
After obesity surgery gastric bypass (GBP) patients usually lose more than 50% of its former preponderance in relative short time (~ 2 years). But knowledge of the underlying biological mechanisms of decline in body weight is still inadequate.
This project intends to examine patients' background activity in the brain (i.e. "the resting state activity") and brain volume using MRI both before and one year after surgery.
Read the detailed description
We will also investigate whether hormonal changes in response to food intake after obesity surgery is associated with patients' impulsive control when exposed to pictures of food in the MRI.
- Conditions
- Obesity, Hormone Responses, Cognitive Health
- Being tested
- Bariatric surgery, Brain activity in resting state, Memory performance
- Keywords
- Bariatric surgery, Cognition, Satiety hormones, Brain networks, Inhibitory control, Food intake
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Gastric bypass surgery
Brain activity in resting stateBehavioural
Measure of activity in brain networks during resting state
Memory performanceBehavioural
Assess concentration in 2D-location task (i.e. "memory game")
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery | Experimental | patients participating in the intervention group , i.e. assessing effects of bariatric surgery on: Brain activity in resting state Memory performance Receives: Procedure: Bariatric surgery; Behavioral: Brain activity in resting state; Behavioral: Memory performance |
| Control | Active comparator | Patients in the control group will not undergo surgery during study.
These patients will be examined twice:
1. 9 weeks before the operation (i.e. clinical intervention to reduce body weight has not started).
2. after 4 weeks of low-calorie diet (which will be a week before their surgery, when patients are in a catabolic metabolism because they eat much less energy than is needed) to assess effect of acute weight loss on: Brain activity in resting state Memory performance Receives: Behavioral: Brain activity in resting state; Behavioral: Memory performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in background activity in the brain (resting state activity) after bariatric surgery
Brain's basic activity and structure will be measured on 3 occasions: 4 weeks before bariatric surgery, 4 weeks after surgery and 1 year after surgery, using fMRI.
Measured: 1 year
Secondary outcomes (1)
Change in response inhibition after bariatric surgery
Inhibitory control to food cues will be measured on 3 occasions: 4 weeks before bariatric surgery, 4 weeks after surgery and 1 year after surgery, using a NoGo-Go task.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
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 ObesityStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital
- Responsible party
- Sponsor
- Investigators
- Magnus Sundbom, MD, Study director, Academic Hospital UppsalaChristian Benedict, PhD, Study director, Uppsala UniversityPleunie Hogenkamp, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815216
- Sponsor's protocol ID
- PH2013b
- Other IDs
- EPN 2012/451
- Status last verified
- Jun 2015
- First submitted
- 18 Mar 2013
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Andreoli MF, De Francesco PN, Zhou W, Titova OE, Alsehli A, Fredriksson R, Sundbom M, Perello M, Schioth HB. Associations of PYY, GLP-1 and LEAP2 with changes in feeding-related cognition, body weight and glucose homeostasis after bariatric surgery in non-diabetic women. J Neuroendocrinol. 2026 Jun;38(6):e70207. doi: 10.1111/jne.70207.
PubMed 42210737
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Bariatric Surgery on Impulsivity and Attentional Bias to Food Cues
- ClinicalTrials.gov ID
- NCT01815216
- Acronym / sponsor ID
- PH2013b
- Conditions
- Obesity, Hormone Responses, Cognitive Health
- Keywords
- Bariatric surgery, Cognition, Satiety hormones, Brain networks, Inhibitory control, Food intake
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala University Hospital
- Study start
- Mar 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 20 Mar 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.
After obesity surgery gastric bypass (GBP) patients usually lose more than 50% of its former preponderance in relative short time (~ 2 years). But knowledge of the underlying biological mechanisms of decline in body weight is still inadequate.
This project intends to examine patients' background activity in the brain (i.e. "the resting state activity") and brain volume using MRI both before and one year after surgery.
Detailed description
We will also investigate whether hormonal changes in response to food intake after obesity surgery is associated with patients' impulsive control when exposed to pictures of food in the MRI.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery | Experimental | Procedure: Bariatric surgery, Behavioral: Brain activity in resting state, Behavioral: Memory performancepatients participating in the intervention group , i.e. assessing effects of bariatric surgery on: Brain activity in resting state Memory performance |
| Control | Active comparator | Behavioral: Brain activity in resting state, Behavioral: Memory performancePatients in the control group will not undergo surgery during study. These patients will be examined twice: 1. 9 weeks before the operation (i.e. clinical intervention to reduce body weight has not started). 2. after 4 weeks of low-calorie diet (which will be a week before their surgery, when patients are in a catabolic metabolism because they eat much less energy than is needed) to assess effect of acute weight loss on: Brain activity in resting state Memory performance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- female
- right-handed
- scheduled for bariatric surgery in the Academic Hospital of Uppsala, Sweden
Key exclusion criteria (2 listed)
- undergone more than one bariatric surgery
- suffer from mental disorders (depression, phobias, etc.) that can not be controlled with treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgeryGastric bypass surgery | Procedure or surgery | Bariatric surgery |
| Brain activity in resting stateMeasure of activity in brain networks during resting state | Behavioural | Bariatric surgery, Control |
| Memory performanceAssess concentration in 2D-location task (i.e. "memory game") | Behavioural | Bariatric surgery, Control |
Primary outcome
Change in background activity in the brain (resting state activity) after bariatric surgery
Time frame: 1 year
Brain's basic activity and structure will be measured on 3 occasions: 4 weeks before bariatric surgery, 4 weeks after surgery and 1 year after surgery, using fMRI.
1 secondary outcome
Change in response inhibition after bariatric surgery
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
- Derived from this study: PubMed 42210737Andreoli MF, De Francesco PN, Zhou W, Titova OE, Alsehli A, Fredriksson R, Sundbom M, Perello M, Schioth HB. Associations of PYY, GLP-1 and LEAP2 with changes in feeding-related cognition, body weight and glucose homeostasis after bariatric surgery in non-diabetic women. J Neuroendocrinol. 2026 Jun;38(6):e70207. doi: 10.1111/jne.70207.
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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.
Magnus Sundbom, MD study director
Academic Hospital Uppsala
Christian Benedict, PhD study director
Uppsala University
Pleunie Hogenkamp, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric surgery, Brain activity in resting state and Memory performance in people with Obesity and Hormone Responses, run by Uppsala University at 1 site in Sweden.
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 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: paused, as of the sponsor's last update on 2 Jun 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 Sweden. 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?
Results are not available in the source record.
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?
Change in background activity in the brain (resting state activity) after bariatric surgery (time frame: 1 year). 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 NCT01815216, 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 2 Jun 2015.