Change in Cognitive Function in Obese Patients After Bari... | NCT01554228

Studies
Change in Cognitive Function in Obese Patients After Bariatric Surgery - an Observational Study

NCT01554228

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Jul 28, 2021Actual

Enrollment

82Actual

Phase

Not provided

Conditions

Obesity
Bariatric Surgery

Interventions

Observation

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011Actual

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Mar 13, 2012

First Submission Date that Met QC Criteria

Mar 13, 2012

First Posted Date

Mar 14, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2021

Last Update Posted Date

Jul 28, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Agnes Flöel, Prof. Dr. med. Agnes Floeel, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bariatric Surgery			Other: Observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other	Observational study to examine changes in cognition following bariatric surgery after one year.	Bariatric Surgery

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
performance in neuropsychological test battery 12 month after surgery compared to performance after 6 month and baseline performance		12 month
performance in further cognitive tests		6 - 12 month

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Patients from the surgery department of the Charite Universtiy Berlin

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Agnes Floeel, Prof. MD	Charite University, Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Surgery Department, Charite University		Berlin		10117	Germany

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided