A Study Using L5 as a Risk Factor of Cardiovascular (CV) Disease in Chronic Renal and Dialytic Patients (L5)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01236820
Recruitment Status : Unknown
Verified November 2010 by China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : November 9, 2010
Last Update Posted : November 9, 2010
Information provided by:
China Medical University Hospital

Brief Summary:
The purpose of this study is to determine whether L5, one of the Low Density Lipoproteins, is an effective predicting factor for cardiovascular disease in chronic renal and hemodialytic patients.

Condition or disease
Cardiovascular Disease Chronic Kidney Disease Patients Hemodialytic Patients High LDL Level High L5 Level

Detailed Description:
Cardiovascular disease (CVD) is the most important cause of death of chronic kidney disease (CKD) and hemodialysis (HD) patients. Low Density Lipoprotein (LDL) is an essential indicator of CVD.The higher the plasma LDL level, the higher the risk of CVD. LDL is a heterogenous substance composed of different mass and size. Oxidized LDL (oxLDL) is the oxidation product of LDL and is the most important component of LDL associated with CVD. The oxLDL is mostly trapped within tissue and not easily to be detected from blood. L5 iw a kind of electronegative LDL and is associated with CVD in smokers and diabetic patients, even if these patients have normal plasma LDL. Uremia patients have lipid profile different from that of general people,while HD Patients have lower LDL and CKD patients have LDL higher than that of general population. Thus LDL plasma level cannot fully explain the high risk of CVD in CKD and HD patients. As patients with normal LDL but high L5 are prone to have CVD, we suspect there might be association of L5 with CVD in both CKD and HD patients.

Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: L5 as a Risk Factor of Cardiovascular Disease in Chronic Kidney Disease and Dialysis Patients
Study Start Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Healthy population
CKD Patients
Chronic Kidney Disease, in Stage III-V
HD patients
End-stage renal disease patients undergoing hemodialysis

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Residents in Taiwan, mostly in Taichung area

Inclusion Criteria:

  • clinical diagnosis of CKD
  • clinical diagnosis of HD

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01236820

Contact: Chiz-Tzung Chang, Ph.D. 886-4-22052121 ext 2902
Contact: Chiu-Ching Huang, MD 886-4-22052121 ext 2902

China Medical University Hospital Recruiting
Taichung City, Taiwan, 404
Contact: Chiu-Ching Huang, MD    886-4-22052121 ext 2902   
Contact: Chiz-Tzung Chang, MD, Ph.D.    886-4-22052121 ext 2902   
Principal Investigator: Chiu-Ching Huang, MD         
Sponsors and Collaborators
China Medical University Hospital

Responsible Party: Chiu-Ching Huang, China Medical University Hospital Identifier: NCT01236820     History of Changes
Other Study ID Numbers: CTCHANG001
First Posted: November 9, 2010    Key Record Dates
Last Update Posted: November 9, 2010
Last Verified: November 2010

Keywords provided by China Medical University Hospital:
Cardiovascular disease
Chronic kidney disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency