NCT01554228

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

6.3 years

First QC Date

March 13, 2012

Last Update Submit

July 27, 2021

Conditions

ObesityBariatric Surgery

Outcome Measures

Primary Outcomes (1)

  • performance in a neuropsychological test battery before and after surgery

    6 month

Secondary Outcomes (3)

  • 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

  • surrogat parameters, blood parameters

    6-12 month

Study Arms (1)

Bariatric Surgery

Other: Observation

Interventions

ObservationOTHER

Observational study to examine changes in cognition following bariatric surgery after one year.

Bariatric Surgery

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients from the surgery department of the Charite Universtiy Berlin

You may qualify if:

  • BMI \> 40
  • Age: 18-60

You may not qualify if:

  • BMI \< 40
  • Age \< 18 and \> 60
  • Presence of Cancer
  • Presence of Chronic Inflammatory Diseases
  • Presence of Addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surgery Department, Charite University

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Obesity

Interventions

Observation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Agnes Floeel, Prof. MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Agnes Floeel

Study Record Dates

First Submitted

March 13, 2012

First Posted

March 14, 2012

Study Start

August 1, 2011

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations

DE(1)