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.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Kaohsiung、台湾、833
- Kaohsiung Chang Gung Memorial Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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change from baseline level of asymmetric dimethylarginine (ADMA) at 24 months
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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change from the baseline health-related quality of life at 24 months
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：You-Lin Tain, MD, PhD、Chang Gung Memorial Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
循環器疾患の臨床試験
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Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ