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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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Kaohsiung, Taiwan, 833
- Kaohsiung Chang Gung Memorial Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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change from baseline level of asymmetric dimethylarginine (ADMA) at 24 months
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
change from the baseline health-related quality of life at 24 months
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: You-Lin Tain, MD, PhD, Chang Gung Memorial Hospital
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 102-4131C
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