Effect of Gastric Bypass Surgery on Brain Responses

Sponsor

Uppsala University (Other)

Overall Status

Suspended

CT.gov ID

NCT01815216

Collaborator

Uppsala University Hospital (Other)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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 or Disease	Intervention/Treatment	Phase
Obesity Hormone Responses Cognitive Health	Procedure: Bariatric surgery Behavioral: Brain activity in resting state Behavioral: Memory performance	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

48 participants

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

Study Start Date :

Mar 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

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: 9 weeks before the operation (i.e. clinical intervention to reduce body weight has not started). 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")

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: 9 weeks before the operation (i.e. clinical intervention to reduce body weight has not started). 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")

Outcome Measures

Primary Outcome Measures

Change in background activity in the brain (resting state activity) after bariatric surgery [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 [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") [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")

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Uppsala University

ClinicalTrials.gov Identifier:

NCT01815216

Other Study ID Numbers:

PH2013b
EPN 2012/451

First Posted:

Mar 20, 2013

Last Update Posted:

Jun 2, 2015

Last Verified:

Jun 1, 2015

Keywords provided by Uppsala University

Study Results

No Results Posted as of Jun 2, 2015