Influence of body weight on brain structure and function, the BARICO study, BAriatric surgery Rijnstate and RadboudUMC neuroImaging and Cognition in Obesity

Completed

• Conditions: Morbide obesitas; Morbid obesity; overweight; 10017998

• Registration Number: NL-OMON55792
• Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>We will assess the effect of bariatric surgery on cognitive performance on<br /><br>computerized neuropsychological tasks as well as brain functioning with MRI<br /><br>parameters, such as changes in cerebral blood flow (ASL) and structural and<br /><br>functional connections (DTI and fMRI). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary study parameters are health status of the liver, adipose tissue and<br /><br>gut, change in microbiota, bloodplasma levels and lifestyle and dietary habits<br /><br>measured at different time-points to determine the relation with cognitive<br /><br>functioning. </p><br>