Effect of Gastric Bypass Surgery on Brain Responses

Obesity Clinical Trial

Official title:

The Effects of Bariatric Surgery on Impulsivity and Attentional Bias to Food Cues

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01815216
• Other study ID #: PH2013b
• Secondary ID: EPN 2012/451
• Status: Suspended
• Phase: N/A
• First received: March 18, 2013
• Last updated: June 1, 2015
• Start date: March 2013
• Est. completion date: December 2016

Study information

• Verified date: June 2015
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 48
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cognitive Health
• Hormone Responses
• Obesity

Intervention

Procedure:
• Bariatric surgery
Gastric bypass surgery

Behavioral:
• Brain activity in resting state
Measure of activity in brain networks during resting state
• Memory performance
Assess concentration in 2D-location task (i.e. "memory game")

Locations

Country	Name	City	State
Sweden	Academic Hospital	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in memory-function after bariatric surgery ("concentration")	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	No
Primary	Change in background activity in the brain (resting state activity) after bariatric surgery	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	No
Secondary	Change in response inhibition after bariatric surgery	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	No