Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec, G1V 4G5, Canada
NCT Number: NCT07704229
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Observational
Québec, Quebec, G1V 4G5, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Vertical sleeve gastrectomy
Time frame: Baseline to 36 months
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
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
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
Composite z-score derived from the Rey Auditory Verbal Learning Test (z-score change).
Time frame: Baseline to 36 months
Montreal Cognitive Assessment (MoCA) score (0-30), with higher scores indicating better cognitive performance.
Time frame: Baseline to 36 months
Mean fractional anisotropy (FA) derived from diffusion tensor imaging (dimensionless, 0-1); Higher FA values generally reflect greater white matter microstructural organization and fiber tract integrity.
Time frame: Baseline to 36 months
Mean diffusivity (MD; mm²/s) derived from diffusion tensor imaging. Higher MD values generally reflect reduced white matter microstructural integrity and increased water diffusion within tissue.
Time frame: Baseline to 36 months
Grey matter density measured using voxel-based morphometry derived from T1-weighted structural MRI (arbitrary units).
Time frame: Baseline to 36 months
Mean cortical thickness (mm) and total surface area (mm²) derived from T1-weighted MRI.
Time frame: Baseline to 36 months
Total white matter hyperintensity volume (mm3) segmented from 3D FLAIR MRI.
Time frame: Baseline to 36 months
Mean arterial lumen diameter (mm) measured in predefined cerebral arteries using TOF-MRA.
Time frame: Baseline to 36 months
Total cerebral arterial volume (mm³) measured from TOF-MRA using automated vessel segmentation.
Time frame: Baseline to 36 months
Regional and whole-brain cerebral blood flow (mL/100g/min) derived from ASL sequences.
Time frame: Baseline to 36 months
Magnetic susceptibility derived from quantitative susceptibility mapping (QSM), a surrogate marker of cerebral iron content (seconds).
Time frame: Baseline to 36 months
Quantitative MRI estimate of brain Water content (%).
Time frame: Baseline to 36 months
Myelin quantitative MRI measure (myelin water fraction, %).
Time frame: Baseline to 36 months
BMI (kg/m2)
Time frame: Baseline to 36 months
Excess weight loss (%)
Time frame: Baseline to 36 months
Total weight (kg), Fat mass (kg) measured by bioimpedance or DXA.
Time frame: Baseline to 36 months
Waist, Hip and Neck circumference (cm).
Time frame: Baseline to 36 months
Fasting glucose (mmol/L)
Time frame: Baseline to 36 months
HbA1c (%)
Time frame: Baseline to 36 months
Fasting Insulin (pmol/L)
Time frame: Baseline to 36 months
HOMA-IR index (fasting glucose (mmol/L) x fasting insulin (pmol/L) / 135)
Time frame: Baseline to 36 months
Fasting Total Cholesterol (mmol/L), High Density Lipoprotein (HDL) cholesterol (mmol/L), Low Density Lipoprotein (LDL) cholesterol (mmol/L), Triglycerides (mmol/L), Apolipoprotein-B (g/L).
Time frame: Baseline to 36 months
Systolic and diastolic blood pressure (mmHg).
Time frame: Baseline to 36 months
CRP (mg/L), IL-6 (pg/mL), LBP (g/mL), BDNF (pg/mL)
Time frame: Baseline to 36 months
Postprandial GLP-1 (pg/mL) and fasting total ghrelin (pmol/L).
Time frame: Baseline to 36 months
Fasting Leptin concentration (ng/mL)
Time frame: Baseline to 36 months
Healthy Eating Index (HEI) Score; Minimum: 0, Maximum: 100.
Time frame: Baseline to 36 months
The Three-Factor Eating Questionnaire (TFEQ) will be used to assess three dimensions of eating behavior: cognitive restraint of eating, uncontrolled/disinhibited eating, and susceptibility to hunger. The questionnaire generates subscale scores for each dimension, with higher scores indicating greater levels of the respective eating behavior construct.
Time frame: Baseline to 36 months
To assess the presence of certain binge eating behaviors that may be indicative of an eating disorder. The higher the score, the more binge eating behaviors is observed. The minimum score is 0 while the maximum score is 46. The final result allows to determine if the person has an absent (less than 17), moderate (between 18 and 26) or severe (more than 27) binging level.
Time frame: Baseline to 36 months
Laval questionnaire evaluating quality of life on 6 aspects on a scale from 0 to 7, higher scores indicate better quality of life.
Time frame: Baseline to 36 months
Beck Depression Inventory. Evaluates severity of depressive symptoms using a validated questionnaire. Minimum score : 0; Maximum score : 63; Higher scores mean a worse outcome.
Time frame: Baseline to 36 months
General Anxiety Disorder questionnaire (GAD-7). Total score ranges from 0 to 21, with an increasing score on the scale is indicating a worse anxiety state.
Time frame: Baseline to 36 months
Pittsburgh Sleep Quality Index questionnaire (PSQI) (19 self-assessment questions grouped into seven components). The scores for the seven components are summed to give an overall score that ranges from 0 to 21, with "0" indicating no difficulty and "21" indicating severe difficulty in all components. A score higher than 5 indicates problematic sleep in one or more components.
Time frame: Baseline to 36 months
Physical activity measured using accelerometry. Outcomes include daily moderate-to-vigorous physical activity (minutes/day) and sedentary time (minutes/day).
Contact information is provided by the study sponsor or research team.
Laval University
Other
Investigating Metabolic, Brain, and Cognitive Alterations Through Bariatric Surgery: Key Determinants and Prospective Outcomes
Acronym: BRAINS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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