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临床试验/NCT03631238
NCT03631238已完成不适用

The Dual Impact of Homocysteine and Cholesterol on Cognitive Functions

Assiut University1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2018年1月15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
41
试验地点
1
主要终点
correlations between serum total cholesterol and homocysteine levels and cognitive functions

研究概览

简要总结

The study evaluates if the relationship between total serum cholesterol is dependent on the total serum homocysteine. Fasting blood samples will taken from participants and two batteries of cognitive scales will be used to asses any cognitive decline.

详细描述

The relationship between total serum cholesterol (TC) levels and cognition remains wily.

Some studies suggested that high TC level in old peoples is associated with a decreased risk of dementia.

Other studies have indicated that hypercholesterolemia may be a risk factor for cognitive decline and Alzheimer's disease (AD).

But a recent study published in 2014 by Cheng and colleagues, showed that, an inverse U-shaped relationship between total cholesterol level and cognitive score was found only in participants with normal homocysteine levels. Indicating that both low and high total serum cholesterol were associated with lower cognitive scores, ended to the relationship between cholesterol levels and cognitive function depends upon homocysteine levels, suggesting an interactive role between cholesterol and homocysteine on cognitive function in the elderly peoples.

The effect of high serum homocysteine (HHcy) levels on cognition was overwhelming regardless of the serum cholesterol levels but in peoples with normal homocysteine levels, both low and high cholesterol levels may be detrimental to cognitive health.

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
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fifty hundred participants
  • Participants are of both genders
  • Aged 55 years old and over.

排除标准

  • Patient with dementia.
  • Renal and hepatic impairment.
  • Parkinson's disease.
  • Cerebrovascular stroke.
  • Patient with chronic medical problems.
  • Patients on statins.

结局指标

主要结局

correlations between serum total cholesterol and homocysteine levels and cognitive functions

时间窗: 1 hour

Blood samples were collected after an overnight fast by using 10 mL plain tubes. Lipid profile was measured by using Cholesterol Kits and analyzed by COBAS Integra analyzer. Total cholesterol levels were measured using the sum of the LDL and HDL plus one-fifth of triglyceride levels. Samples of serum homocysteine (Hcy) are stored in specialized container at (-20◦C) temperature. Total Hcy was measured by ELISA technique, Sinogen kits and Statfax-2100 micro-plate analyzer. Cognitive functions were measured by using the Arabic version of: the 30 points Mini Mental State Exam (MMSE) and the Memory Assessment Scale (MAS) which consists of 12 subtests and the degree of 100 points. The mean of total MAS plus MMSE degrees is used (e.g., (100+30)/2=65 Points which is the maximum score). High, normal and low cholesterol level is compared to the mean of cognitive score only in participants with normal homocysteine levels (below 14 umol/l), higher levels of Hcy is excluded.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

MWAmeen

Principle Investigator

Assiut University

研究点 (1)

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