- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01815216
Effect of Gastric Bypass Surgery on Brain Responses
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Uppsala, Sweden
- Academic Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- female
- right-handed
- scheduled for bariatric surgery in the Academic Hospital of Uppsala, Sweden
Exclusion Criteria:
- undergone more than one bariatric surgery
- suffer from mental disorders (depression, phobias, etc.) that can not be controlled with treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bariatric surgery
patients participating in the intervention group , i.e. assessing effects of bariatric surgery on: Brain activity in resting state Memory performance
|
Gastric bypass surgery
Measure of activity in brain networks during resting state
Assess concentration in 2D-location task (i.e.
"memory game")
|
Active Comparator: Control
Patients in the control group will not undergo surgery during study. These patients will be examined twice:
|
Measure of activity in brain networks during resting state
Assess concentration in 2D-location task (i.e.
"memory game")
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in response inhibition after bariatric surgery
Time Frame: 1 year
|
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.
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in memory-function after bariatric surgery ("concentration")
Time Frame: 1 year
|
Memory performance will be measured on 3 occasions: 4 weeks before bariatric surgery, 4 weeks after surgery and 1 year after surgery - using a a 2D-object location task ("memory game")
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Magnus Sundbom, MD, Academic Hospital Uppsala
- Study Director: Christian Benedict, PhD, Uppsala University
- Principal Investigator: Pleunie Hogenkamp, PhD, Uppsala University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PH2013b
- EPN 2012/451 (Other Identifier: Ethical Board Uppsala)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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