Mechanisms of Chronic Kidney Disease (CKD)-Induced Foam Cell Formation
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Purpose
There is currently little understanding of macrophage cholesterol homeostasis and foam cell formation across the spectrum of CKD. We hypothesize that an inverse relationship exist between the severity of CKD and processes underlying foam cell formation, and that the relationship becomes independent of serum lipoprotein levels as renal function declines. We propose to systematically examine scavenger receptors and cholesterol uptake as well as cholesterol transporters and efflux mechanisms in individuals with normal renal function, patients with moderate CKD and those with ESRD-HD. We further propose to determine if processed contributing to foam cell formation are related to the plasma lipid profile and if the relationship is modified by co-morbidities, such as diabetes, obesity, systemic inflammation which are common in this population and directly influence vascular integrity. These data will be critically important to understand when the abnormality starts and will provide crucial information.
| Condition |
|---|
|
Chronic Kidney Disease Cardiovascular Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | Mechanisms of CKD-Induced Foam Cell Formation |
- In vitro lipoprotein functions [ Time Frame: one year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
ESRD on hemodialysis
Patients with ESRD on hemodialysis(CKD stage V) (ESRD-HD)
|
|
CKD not on dialysis
Patients with CKD not on dialysis (CKD III-IV)
|
|
Controls
Controls with normal kidney function (Control)
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients with ESRD on hemodialysis (CKD stage V) (ESRD-HD)
Patients with CKD not on dialysis (CKD III-IV)
Controls with normal kidney function (Control)
Inclusion Criteria:
- Patients with moderate degree of CKD
- Patients with advanced CKD who have progressed to ESRD requiring maintenance dialysis, and control subjects with intact kidney function
- Male or female
- All ethnic groups
- ESRD-HD with > 6 months of hemodialysis
- > 21 years and have signed informed consent
Exclusion Criteria:
- Pregnancy and current smoking
- Obesity
- Rheumatoid arthritis and systemic lupus erythematosus
Contacts and Locations| United States, Tennessee | |
| Vanderbilt Outpatient Dialysis Center | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Valentina Kon, MD 615-322-4883 valentina.kon@vanderbilt.edu | |
| Principal Investigator: Valentina Kon, MD | |
| Principal Investigator: | Valentina Kon, MD | Vanderbilt University |
More Information
No publications provided
| Responsible Party: | Valentina Kon, Principal Investigatro, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT01671605 History of Changes |
| Other Study ID Numbers: | 090846 |
| Study First Received: | August 20, 2012 |
| Last Updated: | February 27, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Kidney Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on May 23, 2013