跳至主要内容
临床试验/NCT03215888
NCT03215888已完成不适用

Effects of Change in Insulin Resistance and Systemic Inflammation After Bariatric Surgery on Brain Neurochemistry, Neuroinflammation and Cognitive Function

University of Minnesota1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
1
主要终点
Change insulin resistance and inflammatory markers

研究概览

简要总结

Obesity is associated with alterations in brain structure and cognitive impairment and is a risk factor for Alzheimer's disease and vascular dementia. The mechanisms underlying obesity related decline in cognitive function are not fully understood. The long-term goal of this project is to understand how obesity affects cognitive function, with the aim to develop new ways to prevent and treat obesity related cognitive decline

详细描述

A growing body of evidence suggests that obesity is associated with alterations in brain structure and cognitive impairment. Mid-life obesity is a risk factor for Alzheimer's disease and vascular dementia. The mechanisms underlying obesity related decline in cognitive function are not fully understood. The long-term goal of this research is to identify how obesity, insulin resistance (IR), and their treatment impact brain structure and function. The investigators propose that IR and obesity related inflammation are two modifiable factors that affect neuronal integrity and lead to cognitive dysfunction. In this proposal, investigators will test two hypotheses: 1) among obese patients planning to undergo bariatric surgery (specifically vertical sleeve gastrectomy), baseline IR and systemic and brain markers of inflammation will inversely correlate with performance on cognitive testing and correlate with abnormalities in brain structure and 2) following bariatric surgery subjects who experience the greatest reduction in IR and obesity related inflammation will have the greatest improvement in cognitive function and brain structure. To address these hypotheses, investigators will use a comprehensive battery of tests to evaluate cognition and state of the art magnetic resonance imaging (MRI) techniques to assess brain structure and neurochemistry before and six months after bariatric surgery.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Obese Group
  • Undergoing VSG-type bariatric surgery
  • BMI > 30
  • Current weight less than 400 lbs
  • Non-Obese Group
  • Age 30-50
  • BMI < 25

排除标准

  • Both Groups
  • History of type 1 or type 2 diabetes
  • History of stroke
  • History of epilepsy
  • History of Neurosurgical procedures
  • Past or current history of severe psychiatric illness
  • Pass or current history of alcohol or substance abuse
  • Absence of metallic substances in body or ability to remove before imaging procedure
  • History of claustrophobia or known inability to tolerate MRI
  • Inability to consent

结局指标

主要结局

Change insulin resistance and inflammatory markers

时间窗: at baseline (before surgery) and 6 months post surgery

Change in insulin resistance and blood inflammatory markers from baseline (before surgery) and at 6 months post surgery

次要结局

  • change in neurocognitive function testing(at baseline (before surgery) and 6 months post surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验