NCT07704229

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
56mo left

Started Sep 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2031

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

4.3 years

First QC Date

July 9, 2026

Last Update Submit

July 15, 2026

Conditions

Keywords

bariatric surgeryBrainMagnetic Resonance Imaging

Outcome Measures

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.

    Baseline to 36 months

Secondary Outcomes (36)

  • Change in Executive Function Composite Score

    Baseline to 36 months

  • Change in Processing Speed Composite Score

    Baseline to 36 months

  • Change in Memory Composite Score

    Baseline to 36 months

  • Change in Global Cognition

    Baseline to 36 months

  • Change in White Matter Fractional Anisotropy (FA)

    Baseline to 36 months

  • +31 more secondary outcomes

Interventions

Vertical sleeve gastrectomy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andréanne Michaud, DtP, PhD

    Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 9, 2026

First Posted

July 15, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

March 31, 2031

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations