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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleeve Gastrectomy | Procedure | Vertical sleeve gastrectomy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to 36 months |
| Change in Processing Speed Composite Score |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with severe obesity scheduled to undergo SG at the Institut universitaire de cardiologie et pneumologie de Québec - Université Laval (IUCPQ-ULaval).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mélissa Pelletier, MSc | Contact | 418-656-8711 | melissa.pelletier@criucpq.ulaval.ca |
| Name | Affiliation | Role |
|---|---|---|
| Andréanne Michaud, DtP, PhD | Institut universitaire de cardiologie et de pneumologie de Québec, University Laval | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval | Québec | Quebec | G1V 4G5 | Canada |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Composite z-score derived from the Digit Symbol Substitution Test, Trail Making Test Part A, Stroop Color-Word Interference (z-score change).
| Baseline to 36 months |
| Change in Memory Composite Score | Composite z-score derived from the Rey Auditory Verbal Learning Test (z-score change). | Baseline to 36 months |
| Change in Global Cognition | Montreal Cognitive Assessment (MoCA) score (0-30), with higher scores indicating better cognitive performance. | Baseline to 36 months |
| Change in White Matter Fractional Anisotropy (FA) | 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. | Baseline to 36 months |
| Change in White Matter Mean Diffusivity (MD) | 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. | Baseline to 36 months |
| Change in Grey Matter Density | Grey matter density measured using voxel-based morphometry derived from T1-weighted structural MRI (arbitrary units). | Baseline to 36 months |
| Change in Grey Matter Cortical Thickness and Surface Area | Mean cortical thickness (mm) and total surface area (mm²) derived from T1-weighted MRI. | Baseline to 36 months |
| Change in White Matter Hyperintensity Volume | Total white matter hyperintensity volume (mm3) segmented from 3D FLAIR MRI. | Baseline to 36 months |
| Change in Cerebral Artery Diameter | Mean arterial lumen diameter (mm) measured in predefined cerebral arteries using TOF-MRA. | Baseline to 36 months |
| Change in Cerebral Artery Volume | Total cerebral arterial volume (mm³) measured from TOF-MRA using automated vessel segmentation. | Baseline to 36 months |
| Change in Cerebral Blood Flow | Regional and whole-brain cerebral blood flow (mL/100g/min) derived from ASL sequences. | Baseline to 36 months |
| Change in Brain Iron Content as Measured by QMRI Multi-Parameter Mapping Protocol | Magnetic susceptibility derived from quantitative susceptibility mapping (QSM), a surrogate marker of cerebral iron content (seconds). | Baseline to 36 months |
| Change in Brain Water Content as Measured by QMRI Multi-Parameter Mapping Protocol | Quantitative MRI estimate of brain Water content (%). | Baseline to 36 months |
| Change in Brain Myelin Integrity as Measured by QMRI Multi-Parameter Mapping Protocol | Myelin quantitative MRI measure (myelin water fraction, %). | Baseline to 36 months |
| Change in Body Mass Index | BMI (kg/m2) | Baseline to 36 months |
| Change in Percent Excess Weight Loss | Excess weight loss (%) | Baseline to 36 months |
| Change in Body Composition | Total weight (kg), Fat mass (kg) measured by bioimpedance or DXA. | Baseline to 36 months |
| Change in Adiposity | Waist, Hip and Neck circumference (cm). | Baseline to 36 months |
| Change in Glycemic Profile (blood samples) | Fasting glucose (mmol/L) | Baseline to 36 months |
| Change in HbA1c | HbA1c (%) | Baseline to 36 months |
| Change in Insulin (Blood samples) | Fasting Insulin (pmol/L) | Baseline to 36 months |
| Change in HOMA-IR index | HOMA-IR index (fasting glucose (mmol/L) x fasting insulin (pmol/L) / 135) | Baseline to 36 months |
| Change in Lipid Profile (blood samples) | 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). | Baseline to 36 months |
| Change in Vascular Status | Systolic and diastolic blood pressure (mmHg). | Baseline to 36 months |
| Change in Inflammatory Cytokines (blood samples) | CRP (mg/L), IL-6 (pg/mL), LBP (g/mL), BDNF (pg/mL) | Baseline to 36 months |
| Change in Gastrointestinal Hormones (blood samples) | Postprandial GLP-1 (pg/mL) and fasting total ghrelin (pmol/L). | Baseline to 36 months |
| Change in Adipokines (blood samples) | Fasting Leptin concentration (ng/mL) | Baseline to 36 months |
| Change in Dietary Intake and Diet Quality Score (Web-based 24-hour dietary recall) | Healthy Eating Index (HEI) Score; Minimum: 0, Maximum: 100. | Baseline to 36 months |
| Change in Eating Behaviors (Three-Factor Eating Questionnaire) | 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. | Baseline to 36 months |
| Change in Eating Behaviors (Binge Eating Scale) | 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. | Baseline to 36 months |
| Change in Quality of Life (Laval Questionnaire) | Laval questionnaire evaluating quality of life on 6 aspects on a scale from 0 to 7, higher scores indicate better quality of life. | Baseline to 36 months |
| Change in Depression and Anxiety Symptoms (Beck Depression Inventory) | Beck Depression Inventory. Evaluates severity of depressive symptoms using a validated questionnaire. Minimum score : 0; Maximum score : 63; Higher scores mean a worse outcome. | Baseline to 36 months |
| Change in Anxiety | 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. | Baseline to 36 months |
| Change in Quality of Sleep | 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. | Baseline to 36 months |
| Change in Physical Activity | Physical activity measured using accelerometry. Outcomes include daily moderate-to-vigorous physical activity (minutes/day) and sedentary time (minutes/day). | Baseline to 36 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |