Morbide obesitas Morbid obesity overweight
Conditions
Interventions
None listed
Sponsors
Rijnstate Ziekenhuis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Patients aged 35-55 years - BMI > 40 kg/m2 - BMI > 35 and 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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed