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临床试验/NCT03512535
NCT03512535进行中(未招募)不适用

Method Validation for New Nitrogen/Sulfur Species Analysis Techniques

University of Southampton1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2018年1月29日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
220
试验地点
1
主要终点
Concentration of reactive (nitrogen or sulfur containing) species

研究概览

简要总结

Plasma redox status is well known to alter with age but previously differences have only been reported for two specific redox couples; reduced and oxidized cysteine and reduced and oxidized glutathione. (Jones DP, Rejuvenation Res. 2006) The overall aim of this project is to develop new methods to determine how other Reactive Nitrogen and Sulfur species, such as free and protein-bound thiols (organic compounds that contain a Sulfhydryl group, -SH) and Hydrogen Sulfide (H2S) change with age and gender in a medium-sized cohort of healthy individuals (n=100 of either sex; age 18-70).

Our group has recently developed a novel analytical platform to measure thiol-containing compounds in biological samples that is based on the reaction with the thiol-alkylating agent N-ethylmaleimide (NEM). We have used this chemical for years as stabilisation agent in other analyses to quantify Nitric Oxide metabolites.(Feelisch et al, FASEB 2002 and Levett et al, Sci Rep 2011) We now wish to develop a similar method to measure thiol containing compounds using a novel rapid LC-MS/MS based technology for screening large numbers of individuals.

The project will therefore have 2 stages:

  1. Initial method development will require occasional use of whole blood, plasma and red blood cells to establishing optimal conditions. E.g. to compare heparin and EDTA as anticoagulants to serum; investigate effects of temperature and pH; identify optimal concentration of derivatisation/reduction agents and optimal reaction times.
  2. We then aim to establish the normal distribution of these novel compounds across healthy individuals of different gender and varying ages.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Aged 18 years or above
  • Currently healthy (i.e. no inter-current illness/infection)
  • Capacity and ability to give written informed consent

排除标准

  • Current or previous smoker
  • Other medical co-morbidity (e.g. hypertension, diabetes, asthma, COPD, cardiovascular disease, current or previous malignant disease etc.)
  • Surgery within previous 28 days
  • Excessive alcohol intake (i.e above UK's recommended intake limit of 14 units per week).
  • Pregnant or currently breast-feeding
  • On current medication
  • Taken vitamins / minerals / herbal remedies within previous 28 days
  • Difficult venous access
  • Needle phobia
  • Participating in another similar/conflicting research study already

结局指标

主要结局

Concentration of reactive (nitrogen or sulfur containing) species

时间窗: Baseline

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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