Effect of Gastric Bypass Surgery on Brain Responses

June 1, 2015 updated by: Uppsala University

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

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden
        • Academic Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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")

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

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

March 18, 2013

First Submitted That Met QC Criteria

March 18, 2013

First Posted (Estimate)

March 20, 2013

Study Record Updates

Last Update Posted (Estimate)

June 2, 2015

Last Update Submitted That Met QC Criteria

June 1, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

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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