Effect of Gastric Bypass Surgery on Brain Responses

Not Applicable

Suspended

• Conditions: Obesity; Hormone Responses; Cognitive Health
• Interventions: Procedure: Bariatric surgery; Behavioral: Brain activity in resting state; Behavioral: Memory performance

• Registration Number: NCT01815216
• Lead Sponsor: Uppsala University

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.

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 Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-18
• Study First Submitted QC: 2013-03-18
• Study First Posted: 2013-03-20
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-01
• Last Update Posted: 2015-06-02
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Academic Hospital; 🇸🇪 Uppsala, Sweden