Methylation Biosignature in Childhood Chronic Kidney Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Kidney Disease, Cardiovascular Disease

Intervention / Treatment
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* Other: Methylation biosignature


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 2/study, control<br>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. | Other: Methylation biosignature<br>* Methylation biosignature, CKD staging, assessment of cardiovascular function, and traditional/uremia-related risk factors will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline level of asymmetric dimethylarginine (ADMA) at 24 months | at the time of enrollment, 6 months, 12 months, 18 months, and 24 months | from the time of enrollment, every 6 months, up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from the baseline health-related quality of life at 24 months | EQ-5D-Y instrument will be employed at the time of enrollment, 6 months, 12 months, 18 months, 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 | at the time of enrollment, 6 months, 12 months, 18 months, 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 | at the time of enrollment, 6 months, 12 months, 18 months, 24 months | from the time of enrollment, every 6 months, up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic kidney disease, cardiovascular disease, nitric oxide, homocysteine, asymmetric dimethylarginine, methylation