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临床试验/NCT02348775
NCT02348775已完成1 期

Glutathione and Function in HIV Patients

Baylor College of Medicine2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
16
试验地点
2
主要终点
Muscle Glutathione Concentration

研究概览

简要总结

We have recently reported that older patients with HIV are deficient in glutathione (GSH) due to decreased availability of cysteine and glycine, and that oral supplementation with cysteine (as n-acetylcysteine) and glycine for 2-weeks corrects their own levels, and improves (but does not fully normalize) concentrations of red-cell GSH. We also found that when GSH deficient, subjects had impaired mitochondrial fuel oxidation and this improved with an increase in intracellular GSH concentrations. These older HIV patients also had significant increases in muscle strength with improvement of GSH levels.The current proposal in older HIV patients will investigate study if cysteine and glycine supplementation for a duration of 12 weeks will result in changes in : (a) GSH levels; (b) body composition/anthropometry; (c) strength and function; (d) quality of life; (e) mitochondrial energetics; (f) biochemistry (including dyslipidemia and oxidative stress); (g) protein and glucose metabolism; (h) cognition and memory. After completing supplementation for 3 months, GSH concentrations, strength, function, mitochondrial energetics and neurocognitive tests will be measured for a further 2 months to determine the effects of washout.

详细描述

Detailed data are not as yet available

研究设计

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

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HIV patients:
  • age 45-65 years
  • Non-HIV subjects:
  • age 45-65 years

排除标准

  • Hospitalization in the past 3 months
  • Untreated hypothyroidism or hyperthyroidism
  • Known diabetes mellitus, hypercortisolemia, coronary artery disease.
  • Known liver impairment (ALT and AST >2ULN)
  • Renal impairment (Creatinine>1.4)
  • Inability to walk
  • Patients on anticoagulation or antiplatelet therapy.
  • Patient with triglyceride concentrations >500 mg/dl.

结局指标

主要结局

Muscle Glutathione Concentration

时间窗: 20-weeks

Muscle glutathione concentrations measured by liquid chromatography

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

Rajagopal V Sekhar

Associate Professor

Baylor College of Medicine

研究点 (2)

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