Investigating Metabolic, Brain, and Cognitive Alterations Through Bariatric Surgery

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorLaval University

About this trial

Despite global efforts, the prevalence of obesity continues to rise, with rates in Canada tripling over the past three decades. In addition to the well-established risk of cardiometabolic conditions such as heart disease and diabetes, obesity has been associated with cognitive decline and an increased risk of dementia later in life. Sleeve gastrectomy, the most widely used surgical treatment for severe obesity, has proven effective in promoting significant weight loss and improving overall health. Emerging research, including our recent brain imaging study, suggests that this surgery may also have a positive impact on brain health. Our findings demonstrated significant improvements, with patients experiencing reductions in brain age by 2.9 and 5.6 years 12 and 24 months post-surgery, respectively. Despite these promising results, the long-term effects of sleeve gastrectomy on brain health and cognitive function remains poorly understood. While some patients experience cognitive improvements following surgery, others do not, and the factors driving this variability remain unknown.

This proposal aims to comprehensively investigate the impact of bariatric surgery on brain health by examining its cognitive consequences, determinants, and drivers. Understanding the key factors that contribute to brain health improvements after bariatric surgery is essential for optimizing its benefits, preventing relapse and developing personalized interventions to maintain or enhance brain health in individuals living with obesity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women or men between 18 and 65 years who meet the Guidelines for bariatric surgery (BM I≥ 30 kg/m2 with major comorbidities or BMI ≥ 35 kg/m2

Disqualifiers

Pregnancy

Liver cirrhosis

Unstable medical, surgical or psychiatric conditions

Substance or alcohol abuse

Trial population

Participants with severe obesity scheduled to undergo SG at the Institut universitaire de cardiologie et pneumologie de Québec - Université Laval (IUCPQ-ULaval).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Sleeve Gastrectomy

    Procedure/Surgery

    Vertical sleeve gastrectomy

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Change in Estimated Brain Age

Difference between MRI-predicted brain age and chronological age based (delta age, years) derived from a validated machine learning model based on MRI modalities.

Time frame
Baseline to 36 months

Secondary outcomes

1

Change in Executive Function Composite Score

Composite z-score derived from the Stroop Color-Word Interference test, Trail Making Test Part B and Digit Span Test ( z-score change).

Time frame
Baseline to 36 months
2

Change in Processing Speed Composite Score

Composite z-score derived from the Digit Symbol Substitution Test, Trail Making Test Part A, Stroop Color-Word Interference (z-score change).

Time frame
Baseline to 36 months
3

Change in Memory Composite Score

Composite z-score derived from the Rey Auditory Verbal Learning Test (z-score change).

Time frame
Baseline to 36 months
4

Change in Global Cognition

Montreal Cognitive Assessment (MoCA) score (0-30), with higher scores indicating better cognitive performance.

Time frame
Baseline to 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Laval University

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: