Effect of Bariatric Surgery on Cognition, Genetics and Lifestyle

March 3, 2021 updated by: Uppsala University
Obesity bariatric surgery patients usually lose more than 50% of their former obesity within a relatively short time (~ 2 years). There is still a lack of knowledge about underlying psychological and biological mechanisms of decline in body weight. The intention of this project is to investigate whether bariatric surgery is associated with patients' cognitive ability, lifestyle and/or gene expression and metabolomics.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Obese patients with bariatric surgery

Description

Inclusion Criteria:

  • First bariatric surgery

Exclusion Criteria:

  • More than one surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measures 1 y, 2 y, and 5 y after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Uppsala University Hospital

Investigators

  • Principal Investigator: Magnus Sundbom, MD, Academic Hospital Uppsala
  • Study Director: Helgi Schiöth, Prof, Uppsala University
  • Study Director: Olga Titova, PhD, Uppsala University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

January 31, 2014

First Submitted That Met QC Criteria

March 11, 2014

First Posted (Estimate)

March 12, 2014

Study Record Updates

Last Update Posted (Actual)

March 8, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PH2014 (Other Grant/Funding Number: Uppsala University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity, Morbid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe