Effect of Gastric Bypass Surgery on Brain Responses

NCT ID: NCT01815216

Last Updated: 2015-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity Hormone Responses Cognitive Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Bariatric surgery

patients participating in the intervention group , i.e. assessing effects of bariatric surgery on: Brain activity in resting state Memory performance

Group Type EXPERIMENTAL

Bariatric surgery

Intervention Type PROCEDURE

Gastric bypass surgery

Brain activity in resting state

Intervention Type BEHAVIORAL

Measure of activity in brain networks during resting state

Memory performance

Intervention Type BEHAVIORAL

Assess concentration in 2D-location task (i.e. "memory game")

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

Group Type ACTIVE_COMPARATOR

Brain activity in resting state

Intervention Type BEHAVIORAL

Measure of activity in brain networks during resting state

Memory performance

Intervention Type BEHAVIORAL

Assess concentration in 2D-location task (i.e. "memory game")

Interventions

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Bariatric surgery

Gastric bypass surgery

Intervention Type PROCEDURE

Brain activity in resting state

Measure of activity in brain networks during resting state

Intervention Type BEHAVIORAL

Memory performance

Assess concentration in 2D-location task (i.e. "memory game")

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University Hospital

OTHER

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Magnus Sundbom, MD

Role: STUDY_DIRECTOR

Academic Hospital Uppsala

Christian Benedict, PhD

Role: STUDY_DIRECTOR

Uppsala University

Pleunie Hogenkamp, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

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Academic Hospital

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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EPN 2012/451

Identifier Type: OTHER

Identifier Source: secondary_id

PH2013b

Identifier Type: -

Identifier Source: org_study_id

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