Longitudinal Assessment of Cognitive Function Following Bariatric Surgery or Medical Weight Loss Treatment
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Cognitive Function Score - Surgical Group Comparison
研究概览
简要总结
Bariatric surgery is the most effective, long-term treatment for morbid obesity, and consistent with previous findings, individuals who lose significant weight after surgery also have improved cognition or "brain function". The mechanisms behind these cognitive improvements are currently unknown, but are the focus of much research effort. The goal of this pilot study is to thoroughly describe these changes in surgical versus medical weight loss patients over time in a repeated measures fashion.
详细描述
Recent studies have demonstrated that obesity is associated with decreased cognitive function and, interestingly, weight loss is associated with improved cognitive function. Bariatric surgery is the most effective, long-term treatment for morbid obesity, and consistent with these previous findings, individuals who lose significant weight after surgery appear to have improved cognition. Previous results have only reported the appearance of cognitive improvements starting at three months postoperatively, thus, the main focus of this study is to discover whether cognitive function improvements are seen as early as one month after bariatric surgery. An acceleration in the onset of cognitive function changes could provide insight towards the ambiguous underlying neural mechanisms. The benefits of bariatric surgery extend beyond reversible cognitive deficits. Many of the medical comorbid conditions that these patients have before surgery (e.g. high blood pressure, high cholesterol, diabetes) typically resolve prior to any significant weight loss. The mechanisms for these weight-independent improvements are also undetermined. A secondary focus of this study is to determine whether or not cognitive function following bariatric surgery also improves prior to significant weight loss. To test whether cognitive function changes following bariatric surgery, two cohorts of surgical patients will be recruited as well as another group of patients undergoing medical weight loss treatment. The goal of this pilot study is to reproduce and expand upon previous findings that demonstrate cognitive improvements following bariatric surgery.
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •Within the age rage of 18-70 years
- •Able to give informed consent
排除标准
- •Neurological disorder or previous injury (e.g. stoke, dementia, seizures, traumatic brain injury)
- •History of any moderate to severe head injury (i.e. >5 minutes of loss of consciousness)
- •History of severe psychiatric illness requiring current pharmacologic therapy(e.g. schizophrenia, bipolar disorder, personality disorders)
- •History of illicit drug or alcohol abuse
- •Known diagnosis of learning or developmental disability
- •Impaired sensory function
- •Any prior suicide attempt
- •Revisional bariatric surgery
- •Current or former tobacco user / smoker
- •Currently pregnant
结局指标
主要结局
Cognitive Function Score - Surgical Group Comparison
时间窗: Repeated Measures Up to 6 Months
Within group and between group longitudinal measurements will be made using longitudinal regression methods. Baseline as well as 1, 3 and 6 month measurements will be captured either from the time of bariatric surgery or initiation of a supervised medical weight loss program. The bariatric operation will be included (Roux-en-Y gastric bypass vs. Vertical Sleeve Gastrectomy) as a variable in the regression model for between and within subjects comparisons in the bariatric surgery group.
Cognitive Function Score
时间窗: Repeated Measures Up to 6 Months
Within group and between group longitudinal measurements will be made using longitudinal regression methods. Baseline as well as 1, 3 and 6 month measurements will be captured either from the time of bariatric surgery or initiation of a supervised medical weight loss program.
次要结局
- Cognitive Function Score - Crossover Patients(Repeated Measures Up to 6 Months)
研究者
Vance L. Albaugh, MD, PhD
Postdoctoral Fellow and Resident Surgeon
Vanderbilt University Medical Center
