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NCT Number: NCT07704229

Investigating Metabolic, Brain, and Cognitive Alterations Through Bariatric Surgery

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Québec, Quebec, G1V 4G5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Pregnancy
  • Liver cirrhosis
  • Unstable medical, surgical or psychiatric conditions
  • Substance or alcohol abuse
  • Medications affecting the central nervous system
  • Previous gastric, oesophageal, brain, or bariatric surgeries
  • Gastrointestinal inflammatory diseases or ulcers
  • MRI contraindications

Treatment and study plan

Sleeve gastrectomy

Procedure

Vertical sleeve gastrectomy

Primary outcomes

  1. Change in Estimated Brain Age

    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.

Secondary outcomes

  1. Change in Executive Function Composite Score

    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).

  2. Change in Processing Speed Composite Score

    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).

  3. Change in Memory Composite Score

    Time frame: Baseline to 36 months

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

  4. Change in Global Cognition

    Time frame: Baseline to 36 months

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

  5. Change in White Matter Fractional Anisotropy (FA)

    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.

  6. Change in White Matter Mean Diffusivity (MD)

    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.

  7. Change in Grey Matter Density

    Time frame: Baseline to 36 months

    Grey matter density measured using voxel-based morphometry derived from T1-weighted structural MRI (arbitrary units).

  8. Change in Grey Matter Cortical Thickness and Surface Area

    Time frame: Baseline to 36 months

    Mean cortical thickness (mm) and total surface area (mm²) derived from T1-weighted MRI.

  9. Change in White Matter Hyperintensity Volume

    Time frame: Baseline to 36 months

    Total white matter hyperintensity volume (mm3) segmented from 3D FLAIR MRI.

  10. Change in Cerebral Artery Diameter

    Time frame: Baseline to 36 months

    Mean arterial lumen diameter (mm) measured in predefined cerebral arteries using TOF-MRA.

  11. Change in Cerebral Artery Volume

    Time frame: Baseline to 36 months

    Total cerebral arterial volume (mm³) measured from TOF-MRA using automated vessel segmentation.

  12. Change in Cerebral Blood Flow

    Time frame: Baseline to 36 months

    Regional and whole-brain cerebral blood flow (mL/100g/min) derived from ASL sequences.

  13. Change in Brain Iron Content as Measured by QMRI Multi-Parameter Mapping Protocol

    Time frame: Baseline to 36 months

    Magnetic susceptibility derived from quantitative susceptibility mapping (QSM), a surrogate marker of cerebral iron content (seconds).

  14. Change in Brain Water Content as Measured by QMRI Multi-Parameter Mapping Protocol

    Time frame: Baseline to 36 months

    Quantitative MRI estimate of brain Water content (%).

  15. Change in Brain Myelin Integrity as Measured by QMRI Multi-Parameter Mapping Protocol

    Time frame: Baseline to 36 months

    Myelin quantitative MRI measure (myelin water fraction, %).

  16. Change in Body Mass Index

    Time frame: Baseline to 36 months

    BMI (kg/m2)

  17. Change in Percent Excess Weight Loss

    Time frame: Baseline to 36 months

    Excess weight loss (%)

  18. Change in Body Composition

    Time frame: Baseline to 36 months

    Total weight (kg), Fat mass (kg) measured by bioimpedance or DXA.

  19. Change in Adiposity

    Time frame: Baseline to 36 months

    Waist, Hip and Neck circumference (cm).

  20. Change in Glycemic Profile (blood samples)

    Time frame: Baseline to 36 months

    Fasting glucose (mmol/L)

  21. Change in HbA1c

    Time frame: Baseline to 36 months

    HbA1c (%)

  22. Change in Insulin (Blood samples)

    Time frame: Baseline to 36 months

    Fasting Insulin (pmol/L)

  23. Change in HOMA-IR index

    Time frame: Baseline to 36 months

    HOMA-IR index (fasting glucose (mmol/L) x fasting insulin (pmol/L) / 135)

  24. Change in Lipid Profile (blood samples)

    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).

  25. Change in Vascular Status

    Time frame: Baseline to 36 months

    Systolic and diastolic blood pressure (mmHg).

  26. Change in Inflammatory Cytokines (blood samples)

    Time frame: Baseline to 36 months

    CRP (mg/L), IL-6 (pg/mL), LBP (g/mL), BDNF (pg/mL)

  27. Change in Gastrointestinal Hormones (blood samples)

    Time frame: Baseline to 36 months

    Postprandial GLP-1 (pg/mL) and fasting total ghrelin (pmol/L).

  28. Change in Adipokines (blood samples)

    Time frame: Baseline to 36 months

    Fasting Leptin concentration (ng/mL)

  29. Change in Dietary Intake and Diet Quality Score (Web-based 24-hour dietary recall)

    Time frame: Baseline to 36 months

    Healthy Eating Index (HEI) Score; Minimum: 0, Maximum: 100.

  30. Change in Eating Behaviors (Three-Factor Eating Questionnaire)

    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.

  31. Change in Eating Behaviors (Binge Eating Scale)

    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.

  32. Change in Quality of Life (Laval Questionnaire)

    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.

  33. Change in Depression and Anxiety Symptoms (Beck Depression Inventory)

    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.

  34. Change in Anxiety

    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.

  35. Change in Quality of Sleep

    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.

  36. Change in Physical Activity

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Mélissa Pelletier, MSc

CONTACT

[email protected]

418-656-8711

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Investigating Metabolic, Brain, and Cognitive Alterations Through Bariatric Surgery: Key Determinants and Prospective Outcomes

Acronym: BRAINS

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jul 15, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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