Change in Cognitive Function in Obese Patients After Bariatric Surgery - an Observational Study (Obesity)

July 27, 2021 updated by: Agnes Flöel, Charite University, Berlin, Germany
Bariatric surgery provides a strong and long-term effect in reducing weight in obese subjects. Studies showed that obesity and its comorbidities are associated with a lower cognitive performance. The aim of the researchers study is to examine the cognitive performance of the patients before and after bariatric surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Surgery Department, Charite University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from the surgery department of the Charite Universtiy Berlin

Description

Inclusion Criteria:

  • BMI > 40
  • Age: 18-60

Exclusion Criteria:

  • BMI < 40
  • Age < 18 and > 60
  • Presence of Cancer
  • Presence of Chronic Inflammatory Diseases
  • Presence of Addiction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bariatric Surgery
Other: Observation
Observational study to examine changes in cognition following bariatric surgery after one year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
performance in a neuropsychological test battery before and after surgery
Time Frame: 6 month
6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
performance in neuropsychological test battery 12 month after surgery compared to performance after 6 month and baseline performance
Time Frame: 12 month
12 month
performance in further cognitive tests
Time Frame: 6 - 12 month
6 - 12 month
surrogat parameters, blood parameters
Time Frame: 6-12 month
6-12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Agnes Floeel, Prof. MD, Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2011

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

March 13, 2012

First Submitted That Met QC Criteria

March 13, 2012

First Posted (Estimate)

March 14, 2012

Study Record Updates

Last Update Posted (Actual)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Obes_Sur_Cog

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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