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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01554228
First received: March 13, 2012
Last updated: June 2, 2014
Last verified: June 2014
  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Flöel, 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: June 2, 2014
Health Authority: Germany: Charite University Berlin

ClinicalTrials.gov processed this record on October 19, 2014