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:
Charite University, Berlin, Germany
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
| Tracking Information | |||||
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| First Received Date ICMJE | March 13, 2012 | ||||
| Last Updated Date | April 24, 2013 | ||||
| Start Date ICMJE | August 2011 | ||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
performance in a neuropsychological test battery before and after surgery [ Time Frame: 6 month ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01554228 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Change in Cognitive Function in Obese Patients After Bariatric Surgery - an Observational Study | ||||
| Official Title ICMJE | Change in Cognitive Function in Obese Patients After Bariatric Surgery - an Observational Study | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients from the surgery department of the Charite Universtiy Berlin |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Observation
Observational study to examine changes in cognition following bariatric surgery after one year. |
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| Study Group/Cohort (s) | Bariatric Surgery
Intervention: Other: Observation |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 64 | ||||
| Estimated Completion Date | March 2015 | ||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01554228 | ||||
| Other Study ID Numbers ICMJE | Obes_Sur_Cog | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Agnes Floeel, Charite University, Berlin, Germany | ||||
| Study Sponsor ICMJE | Charite University, Berlin, Germany | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Charite University, Berlin, Germany | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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