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Effect of Gastric Bypass Surgery on Brain Responses

U

Uppsala University

Status

Suspended

Conditions

Obesity
Hormone Responses
Cognitive Health

Treatments

Procedure: Bariatric surgery
Behavioral: Memory performance
Behavioral: Brain activity in resting state

Study type

Interventional

Funder types

Other

Identifiers

NCT01815216
PH2013b
EPN 2012/451 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

48 participants in 2 patient groups

Bariatric surgery
Experimental group
Description:
patients participating in the intervention group , i.e. assessing effects of bariatric surgery on: Brain activity in resting state Memory performance
Treatment:
Behavioral: Brain activity in resting state
Behavioral: Memory performance
Procedure: Bariatric surgery
Control
Active Comparator group
Description:
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
Treatment:
Behavioral: Brain activity in resting state
Behavioral: Memory performance

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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