To determine the effect of weight loss after bariatric surgery (BS) on different measures of cognition, brain function and structure investigated with various neuropsychological tests and studying various magnetic resonance imaging (MRI) parameters…
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal therapeutic procedures
Synonym
Health condition
Morbide obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We will assess the effect of bariatric surgery on cognitive performance on
computerized neuropsychological tasks as well as brain functioning with MRI
parameters, such as changes in cerebral blood flow (ASL) and structural and
functional connections (DTI and fMRI).
Secondary outcome
Secundary study parameters are health status of the liver, adipose tissue and
gut, change in microbiota, bloodplasma levels and lifestyle and dietary habits
measured at different time-points to determine the relation with cognitive
functioning.
Background summary
The prevalence of obesity is increasing and nowadays obesity-related diseases
are one of the major health-care problems worldwide. There is a direct link
between increased body mass and cognitive impairment. Body mass can be
immediately decreased by rapid weight loss via bariatric surgery and this is
associated with improved cognitive function. This may be due to changes in the
interaction between metabolic organs and/or changes in the microbiota.
Cognitive benefit after bariatric surgery is not equally exhibited across
patients and decline of cognitive improvements and increase in body weight
after 24 months are as well reported. It has also not been possible to
hypothesize about effects of bariatric surgery on the development of
neurodegenerative diseases such as Alzheimer disease (AD) due to the relatively
short length of follow-up and small numbers of bariatric surgery recipients in
most of the studies reviewed. We therefore want to investigate mechanisms
underlying obesity related disorders via longitudinal studies comprising
neuroimaging and cognitive testing, aiming to elucidate whether the effects of
bariatric surgery on blood, adipose tissue, gut and liver, and microbiota can
attenuate adverse brain changes. Eventually, this study may lead to
identification of mechanisms responsible for cognitive decline in obese
individuals which will support the development of personalized treatments
against obesity and prevention of AD.
Study objective
To determine the effect of weight loss after bariatric surgery (BS) on
different measures of cognition, brain function and structure investigated with
various neuropsychological tests and studying various magnetic resonance
imaging (MRI) parameters. Secondary objectives are to determine health and
inflammation status of adipose tissue, the liver and the gut, in relation to
brain structure and function and whether BS affects gut microbiota composition
and if these changes correlate with the neuropsychological functioning of the
participants Furthermore, in a small study population we want to determine
whether weight loss after bariatric surgery changes the inflammatory and
atherogenic phenotype of innate immune cells. Eventually, this study may lead
to identification of mechanisms responsible for cognitive decline in obese
individuals which will support the development of personalized treatments
against obesity and prevention of AD.
Study design
This study is an observational study, more specific a longitudinal study. The
patients will be tested at different time-points using neuropsychological tests
and analyses on several tissues, before and after Roux-en-Y Gastric Bypass
Surgery (RYGBP). A subgroup of the participants will (next to the other
parameters) be examined using MRI scanning .
Study burden and risks
The tissue biopsies, blood withdrawal and MRI measurements themselves do not
pose any risk, if appropriate precautions are made.
The burden of participation for the subgroup of 75 patients consists of two
visits to the Donders Institute in Nijmegen, undergoing a 45-minute MRI session
in each. For all participants, biological samples will be collected during the
surgery. Therefore, the risks are considered to be minimal, considering the
invasive nature of the surgery itself and the fact that the procedure is
executed under complete anaesthetics. Participants will collect their faeces in
a specially designed collection system that requires very little effort for the
participants. Furthermore, the patients have to fill out some extra
questionnaires and complete some neuropsychological tests next to the standard
questionnaires. At last, maximal 43,5mL extra blood will be withdrawn at 8
time-point during regular blood withdrawal needed for the bariatric surgery.
The patients do not have any additional visits to the hospital or the Dutch
obesity center, all measurements (except MRI) will be performed during the
regular visits and will take an estimated additional 2 hours in total of the
patients* time. 5 and 10 years after surgery we contact the patients againto
fill in the questionnaires and perform the cognitive tests once more.
Furthermore we will again take some extra blood during regular blood
withdrawal. Subjects participating in the study without MRI scanning will be
reimbursed for with ¤90,-, when finishing the 2 year study procedure (patients
in the MRI subgroup will receive ¤135,- and travel expenses).
Wagnerlaan 55
Arnhem 6800 TA
NL
Wagnerlaan 55
Arnhem 6800 TA
NL
Listed location countries
Age
Inclusion criteria
- Patients aged 35-55 years
- BMI > 40 kg/m2
- BMI > 35 and < 40 kg/m2 with co-morbidity, which is expected to improve after
surgically-induced weight loss
- A history of longstanding obesity (> 5 years)
- Proven failed attempts to lose weight in a conventional way, or primarily
successful weight loss with eventual weight regain
- Intention to adhere to a postoperative follow-up programme.
The only additional inclusion criterion for the MRI subgroup (75 patients) of
this study includes:
- Patients must be willing to undergo MRI scanning and perform tasks in the MRI
scanner, at the Donders Institute on three occasions. We include only right
handed patients.
Exclusion criteria
- Previous or current neurological or severe psychiatric illness
- Pregnancy
- Past or current history of alcohol or drug abuse defined by criteria of the
Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV)
- Subjects who received any antibiotic, probiotic, or prebiotic agent three
months before and during the start of the study.
Contra-indications to operative procedures as regular in bariatric surgery
(according to Fried, Interdisciplinary guidelines)
- Psychiatric illness or mental instability, psychotic disorders, severe
depression and personality disorders
- Absence of periods of identifiable medical management
- A patient who is unable to participate in prolonged medical follow-up
- Alcohol abuse and/or drug dependencies
- Diseases threatening life in the short-term or preoperatively
- Patients unable to care for themselves, and without long-term family or
social support that will warrant such care
Contra-indications to MRI scanning:
- Claustrophobia
- Epilepsy
- Pacemakers and defibrillators
- Nerve stimulators
- Intracranial clips
- Intraorbital or intraocular metallic fragments
- Cochlear implants
- Ferromagnetic implants
- Lying circumference above > MRI space capacity
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63493.091.17 |
| Other | NTR 29050 |