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临床试验/NCT01707719
NCT01707719已完成不适用

Isolated Erythrocyte Membrane Susceptibility to Photo-oxidative Stress in Patients Affected by Alzheimer's Disease and Healthy Controls

Raffaele Antonelli Incalzi1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
Malondialdehyde assay

研究概览

简要总结

High lipid peroxidation and altered antioxidant defenses have been frequently reported in Alzheimer's disease patients.

The purpose of this study is to investigate susceptibility to photo-oxidation of isolated erythrocyte membranes, in patients affected by Alzheimer's disease and age- and sex-matched, non demented subjects.

详细描述

The study hypothesis is that high lipid peroxidation and decreased antioxidant defenses characterize the natural history of Alzheimer's disease.

It will be evaluated the release of malondialdehyde (MDA) from ex-vivo photo-oxidized erythrocyte ghosts, through a very easy and convenient lab procedure for the preparation of erythrocyte membrane samples.

Isolated and purified red blood cell membranes will be in vitro exposed to oxidative stress by UV-B radiation. The extent of cell membrane damage will be quantified by the fluorometric determination of MDA.

Induction of oxidative stress through ultraviolet rays, unlike that obtained by chemical oxidizing agents, is fully controllable, since it produces effects only during irradiation. Moreover, using isolated erythrocyte membranes allows for a greater specificity in the evaluation of MDA produced, and reduces the amount of blood required for the assay.

A portion of the blood sample (500 µL) will be sent to the laboratory of Lipinutragen (spin-off of CNR- National Research Center Bologna, Italy) where an erythrocyte membrane lipidomic analysis will be performed for the characterization of membrane phospholipids, in order to determinate the different lipid components (saturated fatty acids, monounsaturated and polyunsaturated, trans fatty acids), each one characterized by a different oxidative reactivity.

研究设计

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

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Outpatients of both sexes diagnosed with Alzheimer's disease according to NINCDS-ADRDA criteria.
  • •Age and sex-matched elderly subjects without dementia.

排除标准

  • •Recent neoplasia (< 1 year)
  • •Vitamin B12 deficiency, positive serology for syphilis, thyroid function abnormalities considered to be significant by the care provider.
  • •Use of vitamin or mineral supplements.
  • •Diagnosis of malnutrition (based on body mass index and total protein levels)
  • •Metabolic syndrome or diabetes.
  • •Hormonal replacement therapy.
  • •Chronic inflammatory disease (e.g. rheumatoid arthritis) and any other acute illness.

结局指标

主要结局

Malondialdehyde assay

时间窗: At the time of recruitment

Isolated and purified red blood cell membranes will be in vitro exposed to oxidative stress by UV-B radiation. The extent of cell membrane damage will be quantified by the fluorometric determination of malondialdehyde.

次要结局

  • Relationship between urinary excretion of cortisol and levels of malondialdehyde(At the time of recruitment)

研究者

发起方
Raffaele Antonelli Incalzi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Raffaele Antonelli Incalzi

Professor

Campus Bio-Medico University

研究点 (1)

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