NCT01815216

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 2, 2015

Status Verified

June 1, 2015

Enrollment Period

3.8 years

First QC Date

March 18, 2013

Last Update Submit

June 1, 2015

Conditions

ObesityHormone ResponsesCognitive Health

Keywords

Bariatric surgeryCognitionSatiety hormonesBrain networksInhibitory controlFood intake

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Change in response inhibition after bariatric surgery

    1 year

Other Outcomes (1)

  • Change in memory-function after bariatric surgery ("concentration")

    1 year

Study Arms (2)

Bariatric surgery

EXPERIMENTAL

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

Procedure: Bariatric surgeryBehavioral: Brain activity in resting stateBehavioral: Memory performance

Control

ACTIVE COMPARATOR

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

Behavioral: Brain activity in resting stateBehavioral: Memory performance

Interventions

Bariatric surgeryPROCEDURE

Gastric bypass surgery

Bariatric surgery
Brain activity in resting stateBEHAVIORAL

Measure of activity in brain networks during resting state

Bariatric surgeryControl
Memory performanceBEHAVIORAL

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

Bariatric surgeryControl

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female
  • right-handed
  • scheduled for bariatric surgery in the Academic Hospital of Uppsala, Sweden

You may not qualify if:

  • undergone more than one bariatric surgery
  • suffer from mental disorders (depression, phobias, etc.) that can not be controlled with treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Hospital

Uppsala, Sweden

Location

MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Magnus Sundbom, MD

    Academic Hospital Uppsala

    STUDY DIRECTOR

  • Christian Benedict, PhD

    Uppsala University

    STUDY DIRECTOR

  • Pleunie Hogenkamp, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2013

First Posted

March 20, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 2, 2015

Record last verified: 2015-06

Locations

SE(1)