Methylation Biosignature in Childhood Chronic Kidney Disease (childhoodCKD)
Methylation Biosignature in Childhood Chronic Kidney Disease: the Link Among Asymmetric Dimethylarginine, Homocysteine, and Cardiovascular Disease
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.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Kaohsiung, 대만, 833
- Kaohsiung Chang Gung Memorial Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- chronic kidney disease stage 1-4
- Volunteer
Exclusion Criteria:
- pregnancy
- renal transplant
- congenital heart disease
- not able to be adherent/complaint with study procedure
- not volunteer
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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2/study, control
Study group: children aged<18 years with chronic kidney disease Control group: children aged<18 years without chronic kidney disease Methylation biosignature, CKD staging, assessment of cardiovascular function, and traditional/uremia-related risk factors will be performed.
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Methylation biosignature, CKD staging, assessment of cardiovascular function, and traditional/uremia-related risk factors will be performed.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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change from baseline level of asymmetric dimethylarginine (ADMA) at 24 months
기간: from the time of enrollment, every 6 months, up to 24 months
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at the time of enrollment, 6 months, 12 months, 18 months, and 24 months
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from the time of enrollment, every 6 months, up to 24 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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change from the baseline health-related quality of life at 24 months
기간: from the time of enrollment, every 6 months, up to 24 months
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EQ-5D-Y instrument will be employed at the time of enrollment, 6 months, 12 months, 18 months, 24 months
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from the time of enrollment, every 6 months, up to 24 months
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change from the baseline ratio of SAM/SAH (S-adenosylmethionine /S-adenosylhomocysteine ) at 24 months
기간: from the time of enrollment, every 6 months, up to 24 months
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at the time of enrollment, 6 months, 12 months, 18 months, 24 months
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from the time of enrollment, every 6 months, up to 24 months
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change from the baseline level of hyperhomocysteinemia (Hcy) at 24 months
기간: from the time of enrollment, every 6 months, up to 24 months
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at the time of enrollment, 6 months, 12 months, 18 months, 24 months
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from the time of enrollment, every 6 months, up to 24 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: You-Lin Tain, MD, PhD, Chang Gung Memorial Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .