Status:
UNKNOWN
Impacts of Bariatric Surgery on the Microbiome and Brain Function
Lead Sponsor:
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Collaborating Sponsors:
Concordia University, Montreal
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Conditions:
Bariatric Surgery Candidate
Weight Loss
Eligibility:
All Genders
30+ years
Brief Summary
Emerging evidence suggests that dietary and metabolic interventions could potentially target prevention and supportive therapies as well as treatments that may slow the clinical deterioration of neuro...
Detailed Description
Dietary patterns are associated with cognitive function and brain morphology. Though certain dietary patterns can impair specific cognitive domains, e.g., declines in reasoning and global cognition, t...
Eligibility Criteria
Inclusion
- Age 30 years or older
- Indeviduals planning to be available for two years of follow-up
- Ability ro read and speak French or English
Exclusion
- A previous bariatric surgery
- Using long-term antibiotics
- Using commercially available prebiotic/probiotic in the past month
- A history of significant intestinal disease/disorder that would influence the microbiome (e.g., Crohn's disease)
- A non-bariatric surgery in the 6 months before being recruited
- A diagnosed neurologic disorder or deficits (e.g., dementia, stroke, or seizures)
- A diagnosis of a severe axis 1 psychotic disorder (e.g., schizophrenia) or bipolar disorder
- A current infection or a diagnosed infectious disease
- Pregnacy or breast feeding
- Active cancer
- Advanced kidney disease
- Advanced liver disease
- Past organ transplantation
- Having any contraindications for undergoing MRI \[i.e., having a cardiac pacemaker (or pacemaker), defibrillator (a heart rhythm device), heart valve prosthesis (a prosthesis in the heart), Swan-Ganz catheter (a tube in the pulmonary artery on the chest), metal insulin or chemotherapy pump under the skin, neurostimulator, brain aneurysm clip (a clip in a blood vessel of the brain), metal prosthesis or rods (following surgery), metal cerclage (metal support on a bone), cochlear or ocular implant (an implant in the ear or eye), penile implant, an intraocular metal fragment (metal debris in the eye), an intrauterine device that does not conform with the MRI, any plastic implants (e.g., breasts) or a patch on the skin for the administration of a medication unless it can remove before scan session\]. Additional requirements for MRI includes patients agreement to: 1) have a pregnancy test and remove makeup, 2) the removal of dentures (full or partial), and 3) provide information on all surgery and previous tattoos (tattoos made for many years or those made in some countries, as the ink contains metallic particles).
- For participants included in the non-bariatric eligible comparison group group, individuals with any physician diagnosed major non-communicable chronic disease, defined as cardiovascular disease, chronic obstructive lung disease, cancer, diabetes, or obesity, will be excluded.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05318781
Start Date
August 1 2022
End Date
May 1 2025
Last Update
August 3 2022
Active Locations (1)
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1
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5