ClinicalTrials.gg
Not yet recruitingNCT07704229BRAINSUpdated Jul 16, 2026

Investigating Metabolic, Brain, and Cognitive Alterations Through Bariatric Surgery

An observational study in Obesity, Morbid, sponsored by Laval University. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by Laval University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 32 studies in Obesity, Morbid with a site in Canada — 7 open to participants now, 10 under way, none of them phase 3. Obesity, Morbid · Canada.

Planned enrollment
5th of 10
150 · median 145
Started
2026
the only one that year
Observational
10 of 32
3 open now
Registered
32nd of 32
by date
Lead sponsor
8 of 32
Laval University

Among the 32 studies in Obesity, Morbid with a site in Canada, this one is the 5th largest by planned enrollment of the 10 observational ones that give a count, is the only one that started in 2026, is one of 10 observational ones, and was the 32nd registered.

Obesity, Morbid

941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.

Browse Obesity, Morbid studies →

Open to participants now

7 of the 32 studies in Obesity, Morbid with a site in Canada are open now. Recruiting first, the newest first:

1 more — sign in →

All 7 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 109 Obesity, Morbid studies recruiting now, 21 (19%) set no upper age limit and 83 (76%) stop at 75 or younger; 8 take children under 18; 9 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 32 studies in Obesity, Morbid with a site in Canada, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Obesity, Morbid

Browse trials for

Keywords

  • bariatric surgery
  • Brain
  • Magnetic Resonance Imaging
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ≥ 35 kg/m2

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Interventions

  • ProcedureSleeve Gastrectomy

    Vertical sleeve gastrectomy

06

What researchers measure

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

  5. 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.

    Time frame: Baseline to 36 months

  6. 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.

    Time frame: Baseline to 36 months

  7. Change in Grey Matter Density

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

    Time frame: Baseline to 36 months

  8. Change in Grey Matter Cortical Thickness and Surface Area

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

    Time frame: Baseline to 36 months

  9. Change in White Matter Hyperintensity Volume

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

    Time frame: Baseline to 36 months

  10. Change in Cerebral Artery Diameter

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

    Time frame: Baseline to 36 months

  11. Change in Cerebral Artery Volume

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

    Time frame: Baseline to 36 months

  12. Change in Cerebral Blood Flow

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

    Time frame: Baseline to 36 months

  13. 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).

    Time frame: Baseline to 36 months

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

    Quantitative MRI estimate of brain Water content (%).

    Time frame: Baseline to 36 months

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

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

    Time frame: Baseline to 36 months

  16. Change in Body Mass Index

    BMI (kg/m2)

    Time frame: Baseline to 36 months

  17. Change in Percent Excess Weight Loss

    Excess weight loss (%)

    Time frame: Baseline to 36 months

  18. Change in Body Composition

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

    Time frame: Baseline to 36 months

  19. Change in Adiposity

    Waist, Hip and Neck circumference (cm).

    Time frame: Baseline to 36 months

  20. Change in Glycemic Profile (blood samples)

    Fasting glucose (mmol/L)

    Time frame: Baseline to 36 months

  21. Change in HbA1c

    HbA1c (%)

    Time frame: Baseline to 36 months

  22. Change in Insulin (Blood samples)

    Fasting Insulin (pmol/L)

    Time frame: Baseline to 36 months

  23. Change in HOMA-IR index

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

    Time frame: Baseline to 36 months

  24. 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).

    Time frame: Baseline to 36 months

  25. Change in Vascular Status

    Systolic and diastolic blood pressure (mmHg).

    Time frame: Baseline to 36 months

  26. Change in Inflammatory Cytokines (blood samples)

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

    Time frame: Baseline to 36 months

  27. Change in Gastrointestinal Hormones (blood samples)

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

    Time frame: Baseline to 36 months

  28. Change in Adipokines (blood samples)

    Fasting Leptin concentration (ng/mL)

    Time frame: Baseline to 36 months

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

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

    Time frame: Baseline to 36 months

  30. 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.

    Time frame: Baseline to 36 months

  31. 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.

    Time frame: Baseline to 36 months

  32. 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.

    Time frame: Baseline to 36 months

  33. 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.

    Time frame: Baseline to 36 months

  34. 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.

    Time frame: Baseline to 36 months

  35. 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.

    Time frame: Baseline to 36 months

  36. Change in Physical Activity

    Physical activity measured using accelerometry. Outcomes include daily moderate-to-vigorous physical activity (minutes/day) and sedentary time (minutes/day).

    Time frame: Baseline to 36 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Dec 2030, 51 months later.

Of 137 non-industry observational studies under Obesity, Morbid, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 132. This study's planned 51 months is above that.

Counting every sponsor, half of 138 studies reached it within 46 months; a quarter within 16 and three quarters within 132.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 9, 2026
First posted
Jul 15, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Dec 31, 2030
CompletionEst.
Mar 31, 2031
Last update
Jul 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07704229
Lead sponsor
Laval University
Collaborators
Canadian Institutes of Health Research (CIHR)
Responsible party
Andréanne Michaud (Associate Professor, Laval University) — Principal investigator
First posted
Jul 15, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Dec 31, 2030 (estimated)
Completion
Mar 31, 2031 (estimated)
Last update
Jul 16, 2026

Study contacts

Mélissa Pelletier, MSc
Contact
melissa.pelletier@criucpq.ulaval.ca
418-656-8711
Andréanne Michaud, DtP, PhD
principal investigator · Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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