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

This study is currently recruiting participants.
Verified April 2013 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Agnes Floeel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01554228
First received: March 13, 2012
Last updated: April 24, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • performance in a neuropsychological test battery before and after surgery [ Time Frame: 6 month ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • performance in further cognitive tests [ Time Frame: 6 - 12 month ] [ Designated as safety issue: No ]
  • surrogat parameters, blood parameters [ Time Frame: 6-12 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: August 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01554228

Locations
Germany
Surgery Department, Charite University Recruiting
Berlin, Germany, 10117
Contact: Agnes Floeel, Prof. MD     0049-30 450 560 284     agnes.floeel@charite.de    
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Agnes Floeel, Prof. MD Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Agnes Floeel, Prof. Dr. med. Agnes Floeel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01554228     History of Changes
Other Study ID Numbers: Obes_Sur_Cog
Study First Received: March 13, 2012
Last Updated: April 24, 2013
Health Authority: Germany: Charite University Berlin

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013