Methylation Biosignature in Childhood Chronic Kidney Disease

NCT02022046 | Completed DMC

• 1 other identifier: 102-4131C
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Cardiovascular Disease

Keywords

chronic kidney disease; cardiovascular disease; nitric oxide; homocysteine; asymmetric dimethylarginine; methylation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• change from the baseline health-related quality of life at 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

  from the time of enrollment, every 6 months, up to 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

Study Arms (1)

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.

Other: Methylation biosignature

Interventions

Methylation biosignature OTHER

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

2/study, control

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children aged \<18 years visit pediatric nephrology clinic during study period

You may qualify if:

• chronic kidney disease stage 1-4
• Volunteer

You may not qualify if:

• pregnancy
• renal transplant
• congenital heart disease
• not able to be adherent/complaint with study procedure
• not volunteer

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• You-Lin Tain, MD, PhD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: December 27, 2013
• Study Start: April 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

TW (1)