NCT01900483

Brief Summary

The project will specifically focus on the examination of the influence of substantial weight loss due to bariatric surgery on brain functions. Our hypothesis is that substantial weight loss after Bariatric Surgery (BS) is also accompanied by changes in the balance of reward and inhibitory networks in diabetic subjects. Therefore the investigators will conduct a functional magnetic resonance imaging (fMRI) study investigating functional measures.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 16, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

First QC Date

July 8, 2013

Last Update Submit

November 9, 2015

Conditions

Adiposity

Outcome Measures

Primary Outcomes (1)

  • Differential brain functions

    brain functions will be measured by blood oxygen level dependent effects

    at least 6 months after bariatric surgery (experimental group)

Other Outcomes (1)

  • Behavioral measurements

    pre surgery (group 1) and at least 6 months after surgery

Study Arms (2)

pre bariatric surgery

post bariatric surgery

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

volunteers pre and post bariatric surgery

You may qualify if:

  • bariatric surgery in the past or in the future
  • diabetes (at least before surgery)

You may not qualify if:

  • fMRI contraindications
  • claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic of Tuebingen, MEG Center

Tübingen, 72076, Germany

Location

Related Publications (1)

  • Frank S, Heinze JM, Fritsche A, Linder K, von Feilitzsch M, Konigsrainer A, Haring HU, Veit R, Preissl H. Neuronal Food Reward Activity in Patients With Type 2 Diabetes With Improved Glycemic Control After Bariatric Surgery. Diabetes Care. 2016 Aug;39(8):1311-7. doi: 10.2337/dc16-0094. Epub 2016 Jun 12.

    PMID: 27293200DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 8, 2013

First Posted

July 16, 2013

Primary Completion

August 1, 2014

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations

DE(1)