Methylation Biosignature in Childhood Chronic Kidney Disease

Completed

• Conditions: Chronic Kidney Disease; Cardiovascular Disease
• Interventions: Other: Methylation biosignature

• Registration Number: NCT02022046
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-11
• Study First Submitted QC: 2013-12-20
• Study First Posted: 2013-12-27
• Study Start: 2014-04
• Primary Completion: 2016-11
• Study Completion: 2016-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-19
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2/study, control	Methylation biosignature	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan