Obesity, MorbidNCT02085369
Effect of Bariatric Surgery on Cognition, Genetics and Lifestyle
An observational study of Obesity, Morbid, run by Uppsala University at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2014to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese patients with bariatric surgery
Who may be able to join
- First bariatric surgery
Who cannot join
- More than one surgery
Trial locations and contacts
1 site in 1 country.
Magnus Sundbom, MD contact
Didi Nordberg, MSc contact
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University Hospital
Uppsala
Magnus Sundbom, magnus.sundbom@akademiska.se
Magnus Sundbom, PhD
About this study
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.
- Conditions
- Obesity, Morbid
- Keywords
- Bariatric surgery, Cognitive function, Gene expression, Metabolomics, Obesity, Overweight, Lifestyle
- Medical subject headings
- Obesity, Morbid, Obesity, Overweight
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gene expression profile (a.o. FTO, BDNF) following a standardized meal (before vs. after surgery)
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
Measured: 1 year
Secondary outcomes (1)
The effect of bariatric surgery on cognitive functioning (inhibitory control, selective attention)
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
Measured: Measures 1 y, 2 y, and 5 y after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital
- Responsible party
- Sponsor
- Investigators
- Magnus Sundbom, MD, Principal investigator, Academic Hospital UppsalaHelgi Schiöth, Prof, Study director, Uppsala UniversityOlga Titova, PhD, Study director, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085369
- Sponsor's protocol ID
- PH2014
- Other IDs
- PH2014
- Status last verified
- Mar 2021
- First submitted
- 31 Jan 2014
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bariatric Surgery on Cognition, Genetics and Lifestyle
- ClinicalTrials.gov ID
- NCT02085369
- Acronym / sponsor ID
- PH2014
- Conditions
- Obesity, Morbid
- Keywords
- Bariatric surgery, Cognitive function, Gene expression, Metabolomics, Obesity, Overweight, Lifestyle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala University Hospital
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 12 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese patients with bariatric surgery
Key inclusion criteria (1 listed)
- First bariatric surgery
Key exclusion criteria (1 listed)
- More than one surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcome
The effect of bariatric surgery on cognitive functioning (inhibitory control, selective attention)
Time frame: Measures 1 y, 2 y, and 5 y after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magnus Sundbom, MD contact
Didi Nordberg, MSc contact
Magnus Sundbom, MD principal investigator
Academic Hospital Uppsala
Helgi Schiöth, Prof study director
Uppsala University
Olga Titova, PhD study director
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magnus Sundbom, MD (magnus.sundbom@akademiska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gene expression profile (a.o. FTO, BDNF) following a standardized meal (before vs. after surgery) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.