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Effect of Gastric Bypass Surgery on Cognition and Genetics

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ClinicalTrials.gov Identifier: NCT02085369
Recruitment Status : Unknown
Verified May 2016 by Uppsala University.
Recruitment status was:  Recruiting
First Posted : March 12, 2014
Last Update Posted : May 12, 2016
Sponsor:
Collaborator:
Uppsala University Hospital
Information provided by (Responsible Party):
Uppsala University

Brief Summary:
Following obesity surgery gastric bypass (GBP) patients usually lose more than 50% of their former obesity within a relatively short time (~ 2 years). But knowledge about the underlying psychological and biological mechanisms of decline in body weight, however, is still lacking. This project intends to investigate whether obesity surgery is associated with patients' cognitive ability and / or gene expression and metabolomics.

Condition or disease
Obesity, Morbid

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Gastric Bypass Surgery on Cognition and Genetics
Study Start Date : January 2014
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Changes in gene expression profile (a.o. FTO, BDNF) following a standardized meal (before vs. after surgery) [ Time Frame: 1 year ]
    Gene expression profiling (whole genome analysis, with first interest in FTO and BDNF expression) to assess changes in gene expression before vs. after surgery, and to associate gene expression with weight loss after surgery


Secondary Outcome Measures :
  1. The effect of bariatric surgery on cognitive functioning (inhibitory control, selective attention) [ Time Frame: Measures 1 y, 2 y, and 5 y after surgery. ]
    No-Go go task (to assess inhibitory control) and Stroop tasks (to assess selective attention) will be measured to assess change in these cognitive functions before vs. after surgery, and to associate cognitive functioning with weight loss after surgery


Biospecimen Retention:   Samples With DNA

A fasted blood sample (50 mL) will be taken before and 2h after a standardized meal.

Through epigenetic study, we will analyze the changes in DNA methylation after surgery in genes related to metabolism (at the Science for Life Laboratory (SciLifeLab) with 450K Human Meth arrays).

In addition, blood samples from these obese patients analyzed (before and after surgery) after ingestion of a predetermined test meal (for example, high protein) to explore changes in metabolites profile. Metabolites in the samples will be quantified by the SciLifeLab.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Obese patients with gastric bypass surgery
Criteria

Inclusion Criteria:

  • First bariatric surgery

Exclusion Criteria:

  • More than one surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02085369


Contacts
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Contact: Magnus Sundbom, MD magnus.sundbom@akademiska.se
Contact: Sofia Kanders, MSc sofia.kanders@neuro.uu.se

Locations
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Sweden
Uppsala University Hospital Recruiting
Uppsala, Sweden
Contact: Magnus Sundbom       magnus.sundbom@akademiska.se   
Principal Investigator: Magnus Sundbom, PhD         
Sponsors and Collaborators
Uppsala University
Uppsala University Hospital
Investigators
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Study Director: Magnus Sundbom, MD Academic Hospital Uppsala
Study Director: Pleunie Hogenkamp, PhD Uppsala University
Study Director: Christian Benedict, PhD Uppsala University
Principal Investigator: Helgi Schiöth, prof Uppsala University

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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT02085369     History of Changes
Other Study ID Numbers: PH2014
PH2014 ( Other Grant/Funding Number: Uppsala University )
First Posted: March 12, 2014    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Keywords provided by Uppsala University:
bariatric surgery
cognitive function
gene expression
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms