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临床试验/NCT02662816
NCT02662816已完成不适用

Feasibility Study of the Quantification of Glutathione Concentrations in Muscle and Liver Using in Vivo Proton Magnetic Resonance Spectroscopy (1H MRS)in Human

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6
试验地点
2
主要终点
Signal-to-noise ratio of glutathione detected in liver and muscle

研究概览

简要总结

Glutathione (glutamyl-cysteinyl-glycine) is the main intracellular compound. It participates also in the detoxification of electrophiles molecules of which paracetamol. It is synthesized in the liver during the postprandial phase, which establishes a stock that is mobilized for the other tissues (muscle)during the postabsorptive period. It is of common knowledge that the decrease in glutathione concentrations associated with ageing could be involved in the development of the degenerative pathologies linked to the old age. These changes could be reversed by an increase in dietary cysteine, the amino acid limiting of the endogenous synthesis of GSH. The development of nutritional strategies aiming at an improvement of the status glutathione requires the determination of its concentration within tissues, where it is active. The quantification of tissue concentrations of glutathione by biochemical techniques requires tissue biopsies. Such a method can be performed for the muscle, but liver biopsy is not feasible outside of a surgery. It is necessary to set up a non-invasive method to quantify muscle and liver glutathione.

详细描述

The study will validate the detection and the quantification of glutathione in muscle and liver using 1H MRS. The accuracy of the method will be assessed from intra and inter-volunteer measurements. 1H MRS measurements will be performed with the Magnetic Resonance Imaging (MRI) 3 Tesla system of the Hospital, twice for each volunteer.

Prior to the measurements, volunteers will have a protein rich breakfast at home and a protein rich lunch at the Clinical Investigation Center.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Days 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • - Healthy Volunteers, men or women, from 18 to 35 years old
  • Having filled the questionnaire of compatibility in the MRI and having no contraindication in the MRI
  • Having given their written, free and informed consent
  • Affiliated with a social security system
  • 19 < BMI < 25 kg.m-2

排除标准

  • - Age < 18 ans ou > 35 ans
  • BMI < 19 ou > 25 kg.m-2
  • Carrier of a pacemaker, cochlear implants, metallic implants or magnetic element (cf questionnaire of compatibility in the MRI, Appendix 3)
  • Under treatment with repeated doses of paracetamol during the 2 weeks preceding the inclusion
  • Under treatment in N-acetylcysteine during 2 weeks preceding the inclusion
  • Regular sporttraining > 3 hours / week
  • Claustrophobia
  • Difficulty of being immobile
  • Pregnant women or women who are breast-feeding
  • Incapacitated legal (private person of freedom or under guardianship)
  • People who cannot be followed and/or compliant in the requirements of the study for psychological, social, family or geographical reasons,
  • People already included in another clinical trial

结局指标

主要结局

Signal-to-noise ratio of glutathione detected in liver and muscle

时间窗: 2 h after the lunch.

次要结局

  • Glutathione concentrations in intravariabilities(2 h after the lunch)
  • Glutathione concentrations in means(2 h after the lunch)
  • Glutathione concentrations in muscle(2 h after the lunch)
  • Glutathione concentrations in liver(2 h after the lunch)
  • Glutathione concentrations in intervariabilities(2 h after the lunch)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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