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临床试验/NCT05215886
NCT05215886Enrolling By Invitation不适用

Cognitive Impairment, Obesity, and the Effects of Bariatric Surgery

University of California, Davis1 个研究点 分布在 1 个国家目标入组 9,500 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
9,500
试验地点
1
主要终点
California Verbal Learning Test-3rd Edition (CVLT-3)

研究概览

简要总结

Study is designed to screen psychological cognitive baseline and retention/improvement after weight loss surgery.

详细描述

Patients with morbid obesity have shown to be at increased risk for memory loss and cognitive decline. Obesity and high-fat diets have been associated with deficits in learning, memory, and executive functioning. Bariatric surgery results in significant weight loss for patients and helps resolve obesity-related comorbidities such as diabetes and high blood pressure. Interestingly, bariatric surgery has shown promise in improving some aspects of cognitive function and improved memory. (3-1) Obesity affects brain structure, more specifically the grey and white matter, likely in part by reducing oxygen flow to the various regions in the brain. Studies have shown a correlation between BMI and cerebral blood flow velocity (CBFV), where higher BMI is associated with lower CBFV. Although it is not clear how exactly obesity plays a role in the brain's structural and functional changes, observations revealed compromised grey and white matter integrity, its fiber connectivity or cortical atrophy and metabolic alterations. (2)

Few studies exist on the impact of bariatric surgery on cognition. Some studies have shown that patients with obesity who underwent bariatric surgery had memory and cognitive improvement compared to those who had not undergone surgery. (4) Thus, the investigators hope to add to our understanding of how bariatric surgery can improve cognitive decline and to potentially offer surgery to more patients with baseline cognitive impairment and to improve cognitive function overall for patients with obesity. More longitudinal studies need to be done to connect bariatric surgery effects with cognitive decline, specifically memory.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cognitive impairment/decline, memory impairment/loss, or Alzheimer's disease or dementia and bariatric surgery • Cognitive impairment/decline, memory impairment/loss, or Alzheimer's disease or dementia and obesity, and no bariatric surgery history

排除标准

  • Patients without a history of memory impairment/loss, bariatric surgery, or obesity
  • Patients outside of University of California Davis Health System
  • Patients unable to provide consent

结局指标

主要结局

California Verbal Learning Test-3rd Edition (CVLT-3)

时间窗: 12 Months after index screening/date of surgery

Measures episodic verbal learning including Verbal Learning, immediate memory, and delayed memory

次要结局

  • WAIS-IV Digit Span Forward & Backward(12 months after Index screening/date of surgery)
  • Stroop Color and Word Test; Word, Color & Word-Color(12 months after index screening/date of surgery)
  • Brief Visuospatial Memory Test(Pre-operatively)
  • Trial Making Test, A & B(12 months after index screening/date of surgery)
  • Verbal Fluency, Phonemic & Semantic(12 months after index screening/date of surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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