Methylation Biosignature in Childhood Chronic Kidney Disease

Cardiovascular Disease Clinical Trial

— childhoodCKD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02022046
• Other study ID #: 102-4131C
• Status: Completed
• Phase: N/A
• First received: December 11, 2013
• Last updated: July 19, 2017
• Start date: April 2014
• Est. completion date: December 2016

Study information

• Verified date: July 2017
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Methylation biosignature
Methylation biosignature, CKD staging, assessment of cardiovascular function, and traditional/uremia-related risk factors will be performed.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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