Investigating Metabolic, Brain, and Cognitive Alterations Through Bariatric Surgery: Key Determinants and Prospective Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Estimated Brain Age
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Estimated Brain Age
时间窗: 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.
次要结局
- Change in Body Mass Index(Baseline to 36 months)
- Change in Percent Excess Weight Loss(Baseline to 36 months)
- 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)
- Change in White Matter Mean Diffusivity (MD)(Baseline to 36 months)
- Change in Grey Matter Density(Baseline to 36 months)
- Change in Grey Matter Cortical Thickness and Surface Area(Baseline to 36 months)
- Change in White Matter Hyperintensity Volume(Baseline to 36 months)
- Change in Cerebral Artery Diameter(Baseline to 36 months)
- Change in Cerebral Artery Volume(Baseline to 36 months)
- Change in Cerebral Blood Flow(Baseline to 36 months)
- Change in Brain Iron Content as Measured by QMRI Multi-Parameter Mapping Protocol(Baseline to 36 months)
- Change in Brain Water Content as Measured by QMRI Multi-Parameter Mapping Protocol(Baseline to 36 months)
- Change in Brain Myelin Integrity as Measured by QMRI Multi-Parameter Mapping Protocol(Baseline to 36 months)
- Change in Body Composition(Baseline to 36 months)
- Change in Adiposity(Baseline to 36 months)
- Change in Lipid Profile (blood samples)(Baseline to 36 months)
- Change in Inflammatory Cytokines (blood samples)(Baseline to 36 months)
- Change in Vascular Status(Baseline to 36 months)
- Change in Gastrointestinal Hormones (blood samples)(Baseline to 36 months)
- Change in Adipokines (blood samples)(Baseline to 36 months)
- Change in Dietary Intake and Diet Quality Score (Web-based 24-hour dietary recall)(Baseline to 36 months)
- Change in Eating Behaviors (Three-Factor Eating Questionnaire)(Baseline to 36 months)
- Change in Eating Behaviors (Binge Eating Scale)(Baseline to 36 months)
- Change in Quality of Life (Laval Questionnaire)(Baseline to 36 months)
- Change in Depression and Anxiety Symptoms (Beck Depression Inventory)(Baseline to 36 months)
- Change in Anxiety(Baseline to 36 months)
- Change in Quality of Sleep(Baseline to 36 months)
- Change in Physical Activity(Baseline to 36 months)
- Change in Glycemic Profile (blood samples)(Baseline to 36 months)
- Change in HbA1c(Baseline to 36 months)
- Change in Insulin (Blood samples)(Baseline to 36 months)
- Change in HOMA-IR index(Baseline to 36 months)
研究者
Andréanne Michaud
Associate Professor
Laval University