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Not yet recruiting NCT07704229

Investigating Metabolic, Brain, and Cognitive Alterations Through Bariatric Surgery

— Observational Obesity, Morbid

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sleeve Gastrectomy.
Who it may be relevant to
Registry conditions: Obesity, Morbid. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Procedure Sleeve Gastrectomy
    Vertical sleeve gastrectomy

Primary outcome measures

  • Change in Estimated Brain Age [Time frame: Baseline to 36 months]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval — Québec

Identifiers

NCT: NCT07704229 · 2027-4579

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗