Obesity, MorbidBRAINSNCT07704229
Investigating Metabolic, Brain, and Cognitive Alterations Through Bariatric Surgery
An observational study of Obesity, Morbid, run by Laval University at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Sleeve Gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2026to 31 Mar 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with severe obesity scheduled to undergo SG at the Institut universitaire de cardiologie et pneumologie de Québec - Université Laval (IUCPQ-ULaval).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec, G1V 4G5
About this study
Official title: Investigating Metabolic, Brain, and Cognitive Alterations Through Bariatric Surgery: Key Determinants and Prospective Outcomes
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.
- Conditions
- Obesity, Morbid
- Being tested
- Sleeve Gastrectomy
- Keywords
- bariatric surgery, Brain, Magnetic Resonance Imaging
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve GastrectomyProcedure or surgery
Vertical sleeve gastrectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 36 months
Secondary outcomes (36)
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).
Measured: Baseline to 36 months
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).
Measured: Baseline to 36 months
Change in Memory Composite Score
Composite z-score derived from the Rey Auditory Verbal Learning Test (z-score change).
Measured: Baseline to 36 months
Change in Global Cognition
Montreal Cognitive Assessment (MoCA) score (0-30), with higher scores indicating better cognitive performance.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline to 36 months
Change in White Matter Hyperintensity Volume
Total white matter hyperintensity volume (mm3) segmented from 3D FLAIR MRI.
Measured: Baseline to 36 months
Change in Cerebral Artery Diameter
Mean arterial lumen diameter (mm) measured in predefined cerebral arteries using TOF-MRA.
Measured: Baseline to 36 months
Change in Cerebral Artery Volume
Total cerebral arterial volume (mm³) measured from TOF-MRA using automated vessel segmentation.
Measured: Baseline to 36 months
Change in Cerebral Blood Flow
Regional and whole-brain cerebral blood flow (mL/100g/min) derived from ASL sequences.
Measured: 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).
Measured: Baseline to 36 months
Change in Brain Water Content as Measured by QMRI Multi-Parameter Mapping Protocol
Quantitative MRI estimate of brain Water content (%).
Measured: Baseline to 36 months
Change in Brain Myelin Integrity as Measured by QMRI Multi-Parameter Mapping Protocol
Myelin quantitative MRI measure (myelin water fraction, %).
Measured: Baseline to 36 months
Change in Body Mass Index
BMI (kg/m2)
Measured: Baseline to 36 months
Change in Percent Excess Weight Loss
Excess weight loss (%)
Measured: Baseline to 36 months
Change in Body Composition
Total weight (kg), Fat mass (kg) measured by bioimpedance or DXA.
Measured: Baseline to 36 months
Change in Adiposity
Waist, Hip and Neck circumference (cm).
Measured: Baseline to 36 months
Change in Glycemic Profile (blood samples)
Fasting glucose (mmol/L)
Measured: Baseline to 36 months
Change in HbA1c
HbA1c (%)
Measured: Baseline to 36 months
Change in Insulin (Blood samples)
Fasting Insulin (pmol/L)
Measured: Baseline to 36 months
Change in HOMA-IR index
HOMA-IR index (fasting glucose (mmol/L) x fasting insulin (pmol/L) / 135)
Measured: 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).
Measured: Baseline to 36 months
Change in Vascular Status
Systolic and diastolic blood pressure (mmHg).
Measured: Baseline to 36 months
Change in Inflammatory Cytokines (blood samples)
CRP (mg/L), IL-6 (pg/mL), LBP (g/mL), BDNF (pg/mL)
Measured: Baseline to 36 months
Change in Gastrointestinal Hormones (blood samples)
Postprandial GLP-1 (pg/mL) and fasting total ghrelin (pmol/L).
Measured: Baseline to 36 months
Change in Adipokines (blood samples)
Fasting Leptin concentration (ng/mL)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Andréanne Michaud, Laval University
- Investigators
- Andréanne Michaud, DtP, PhD, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704229
- Sponsor's protocol ID
- 2027-4579
- Acronym
- BRAINS
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Metabolic, Brain, and Cognitive Alterations Through Bariatric Surgery: Key Determinants and Prospective Outcomes
- ClinicalTrials.gov ID
- NCT07704229
- Acronym / sponsor ID
- BRAINS / 2027-4579
- Conditions
- Obesity, Morbid
- Keywords
- bariatric surgery, Brain, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with severe obesity scheduled to undergo SG at the Institut universitaire de cardiologie et pneumologie de Québec - Université Laval (IUCPQ-ULaval).
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- Pregnancy
- Liver cirrhosis
- Unstable medical, surgical or psychiatric conditions
- Substance or alcohol abuse
- Medications affecting the central nervous system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleeve GastrectomyVertical sleeve gastrectomy | Procedure or surgery | – |
Primary outcome
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.
36 secondary outcomes
Change in Executive Function Composite Score
Time frame: Baseline to 36 months
Change in Processing Speed Composite Score
Time frame: Baseline to 36 months
Change in Memory Composite Score
Time frame: Baseline to 36 months
Change in Global Cognition
Time frame: Baseline to 36 months
Change in White Matter Fractional Anisotropy (FA)
Time frame: Baseline to 36 months
Change in White Matter Mean Diffusivity (MD)
Time frame: Baseline to 36 months
Change in Grey Matter Density
Time frame: Baseline to 36 months
Change in Grey Matter Cortical Thickness and Surface Area
Time frame: Baseline to 36 months
Change in White Matter Hyperintensity Volume
Time frame: Baseline to 36 months
Change in Cerebral Artery Diameter
Time frame: Baseline to 36 months
Change in Cerebral Artery Volume
Time frame: Baseline to 36 months
Change in Cerebral Blood Flow
Time frame: Baseline to 36 months
Change in Brain Iron Content as Measured by QMRI Multi-Parameter Mapping Protocol
Time frame: Baseline to 36 months
Change in Brain Water Content as Measured by QMRI Multi-Parameter Mapping Protocol
Time frame: Baseline to 36 months
Change in Brain Myelin Integrity as Measured by QMRI Multi-Parameter Mapping Protocol
Time frame: Baseline to 36 months
Change in Body Mass Index
Time frame: Baseline to 36 months
Change in Percent Excess Weight Loss
Time frame: Baseline to 36 months
Change in Body Composition
Time frame: Baseline to 36 months
Change in Adiposity
Time frame: Baseline to 36 months
Change in Glycemic Profile (blood samples)
Time frame: Baseline to 36 months
Change in HbA1c
Time frame: Baseline to 36 months
Change in Insulin (Blood samples)
Time frame: Baseline to 36 months
Change in HOMA-IR index
Time frame: Baseline to 36 months
Change in Lipid Profile (blood samples)
Time frame: Baseline to 36 months
Change in Vascular Status
Time frame: Baseline to 36 months
Change in Inflammatory Cytokines (blood samples)
Time frame: Baseline to 36 months
Change in Gastrointestinal Hormones (blood samples)
Time frame: Baseline to 36 months
Change in Adipokines (blood samples)
Time frame: Baseline to 36 months
Change in Dietary Intake and Diet Quality Score (Web-based 24-hour dietary recall)
Time frame: Baseline to 36 months
Change in Eating Behaviors (Three-Factor Eating Questionnaire)
Time frame: Baseline to 36 months
Change in Eating Behaviors (Binge Eating Scale)
Time frame: Baseline to 36 months
Change in Quality of Life (Laval Questionnaire)
Time frame: Baseline to 36 months
Change in Depression and Anxiety Symptoms (Beck Depression Inventory)
Time frame: Baseline to 36 months
Change in Anxiety
Time frame: Baseline to 36 months
Change in Quality of Sleep
Time frame: Baseline to 36 months
Change in Physical Activity
Time frame: Baseline to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andréanne Michaud, DtP, PhD principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mélissa Pelletier, MSc (418-656-8711, melissa.pelletier@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Estimated Brain Age (time frame: Baseline to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.