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Effect of Gastric Bypass Surgery on Brain Responses

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01815216
First Posted: March 20, 2013
Last Update Posted: June 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Uppsala University Hospital
Information provided by (Responsible Party):
Uppsala University
  Purpose

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.


Condition Intervention
Obesity Hormone Responses Cognitive Health Procedure: Bariatric surgery Behavioral: Brain activity in resting state Behavioral: Memory performance

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of Bariatric Surgery on Impulsivity and Attentional Bias to Food Cues

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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")


Estimated Enrollment: 48
Study Start Date: March 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bariatric surgery
patients participating in the intervention group , i.e. assessing effects of bariatric surgery on: Brain activity in resting state Memory performance
Procedure: Bariatric surgery
Gastric bypass surgery
Behavioral: Brain activity in resting state
Measure of activity in brain networks during resting state
Behavioral: Memory performance
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:

  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
Behavioral: Brain activity in resting state
Measure of activity in brain networks during resting state
Behavioral: Memory performance
Assess concentration in 2D-location task (i.e. "memory game")

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815216


Locations
Sweden
Academic Hospital
Uppsala, Sweden
Sponsors and Collaborators
Uppsala University
Uppsala University Hospital
Investigators
Study Director: Magnus Sundbom, MD Academic Hospital Uppsala
Study Director: Christian Benedict, PhD Uppsala University
Principal Investigator: Pleunie Hogenkamp, PhD Uppsala University
  More Information

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01815216     History of Changes
Other Study ID Numbers: PH2013b
EPN 2012/451 ( Other Identifier: Ethical Board Uppsala )
First Submitted: March 18, 2013
First Posted: March 20, 2013
Last Update Posted: June 2, 2015
Last Verified: June 2015

Keywords provided by Uppsala University:
Bariatric surgery
Cognition
Satiety hormones
Brain networks
Inhibitory control
Food intake