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临床试验/NCT02022046
NCT02022046已完成不适用

Methylation Biosignature in Childhood Chronic Kidney Disease: the Link Among Asymmetric Dimethylarginine, Homocysteine, and Cardiovascular Disease

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2014年4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
69
试验地点
1
主要终点
change from baseline level of asymmetric dimethylarginine (ADMA) at 24 months

研究概览

简要总结

Chronic kidney disease (CKD) and end-stage renal disease are highly prevalent in Taiwan. Cardiovascular disease (CVD) is the most common cause of death in children with CKD. Nitric oxide (NO) deficiency links CKD and CVD. Asymmetric dimethylarginine (ADMA), a NO synthase inhibitor, its level is increased in kidney disease and cardiovascular disease and serves as a methylation biomarker.

In addition to ADMA, uremic environment, hyperhomocysteinemia (Hcy) and oxidative stress may affect DNA methylation. S-adenosylmethionine (SAM) is an important human methyl donor. S-adenosylhomocysteine (SAH) is demethylated product. Methylenetetrahydrofolate reductase (MTHFR), a folate metabolism enzyme can regulate methylation pathway.

The investigators intend to examine whether ADMA, SAM/SAH ratio, Hcy, and MTHFR gene methylation can serve as biosignature to predict CVD in children with CKD children.

研究设计

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

入排标准

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

入选标准

  • chronic kidney disease stage 1-4
  • Volunteer

排除标准

  • pregnancy
  • renal transplant
  • congenital heart disease
  • not able to be adherent/complaint with study procedure
  • not volunteer

结局指标

主要结局

change from baseline level of asymmetric dimethylarginine (ADMA) at 24 months

时间窗: from the time of enrollment, every 6 months, up to 24 months

at the time of enrollment, 6 months, 12 months, 18 months, and 24 months

次要结局

  • change from the baseline health-related quality of life at 24 months(from the time of enrollment, every 6 months, up to 24 months)
  • change from the baseline ratio of SAM/SAH (S-adenosylmethionine /S-adenosylhomocysteine ) at 24 months(from the time of enrollment, every 6 months, up to 24 months)
  • change from the baseline level of hyperhomocysteinemia (Hcy) at 24 months(from the time of enrollment, every 6 months, up to 24 months)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tain, You-Lin

MD, PhD

Chang Gung Memorial Hospital

研究点 (1)

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