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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01554228
First Posted: March 14, 2012
Last Update Posted: December 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany
  Purpose
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.

Condition Intervention
Obesity Bariatric Surgery Other: Observation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Change in Cognitive Function in Obese Patients After Bariatric Surgery - an Observational Study

Resource links provided by NLM:


Further study details as provided by Agnes Flöel, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • performance in a neuropsychological test battery before and after surgery [ Time Frame: 6 month ]

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

Estimated Enrollment: 64
Study Start Date: August 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Bariatric Surgery Other: Observation
Observational study to examine changes in cognition following bariatric surgery after one year.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from the surgery department of the Charite Universtiy Berlin
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01554228


Locations
Germany
Surgery Department, Charite University
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Agnes Floeel, Prof. MD Charite University, Berlin, Germany
  More Information

Responsible Party: Agnes Flöel, Prof. Dr. med. Agnes Floeel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01554228     History of Changes
Other Study ID Numbers: Obes_Sur_Cog
First Submitted: March 13, 2012
First Posted: March 14, 2012
Last Update Posted: December 21, 2016
Last Verified: December 2016