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NCT00350974 · ClinicalTrials.gov registry record
ADMA Levels in End-Stage Renal Disease
A clinical trial, sponsored by University of Michigan.
- Completed
- Registry status
- 61
- Enrollment target
NCT00350974 is a clinical trial that has completed, run by University of Michigan. The registered enrollment target is 61 participants.
The verdict
NCT00350974 has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- 61 participants
- Enrollment target
Study Summary
Asymmetric dimethylarginine, ADMA, in plasma, is significantly elevated in patients with renal disease and associated with cardiovascular morbidity and mortality. We found that whole blood (WB) possesses the metabolic pathways required for both the generation and elimination of ADMA and we have developed ex vivo methods to assess the WB accumulation of ADMA in humans. The over-arching hypothesis is that dysregulation of ADMA metabolic pathways leads to greater ADMA whole blood content and greater capacity to accumulate ADMA, which 1) is not reflected by plasma levels and 2) is a better predictor of cardiovascular outcome than plasma levels in end-stage renal disease (ESRD). The following specific aims will be pursued to characterize whole blood ADMA in ESRD: 1. Compare and contrast baseline free plasma ADMA and total whole blood (free plus protein-incorporated) ADMA concentrations in ESRD patients, matched hypertensive controls and a normal population. 2. Determine the capacity of WB to accumulate (the net balance of generation and elimination) ADMA in ESRD patients, matched hypertensive controls and a normal population. We will use state-of-the-art, high performance liquid chromatography techniques to measure ADMA levels in plasma and whole blood. Samples for ADMA measurements will be obtained from subjects with end-stage renal disease immediately before their dialysis treatments. Samples will also be obtained from volunteers without kidney disease. This group will be matched to the end-stage renal volunteers by age, gender and ethnicity. These volunteers will also be matched for the presence of hypertension and diabetes. The third group will consist of a normal population to measure the normal levels of ADMA and compare to the other two groups. There is growing evidence to support a pathological role of ADMA in humans. These experiments will enhance our understanding of how ADMA is processed in the human body and how it is associated with kidney disease. Potent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2006-07 |
| Est. Completion | 2007-03-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00350974
The ClinicalTrials.gov registry entry for NCT00350974 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00350974 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00350974 about?
NCT00350974 is a clinical study titled "ADMA Levels in End-Stage Renal Disease". Asymmetric dimethylarginine, ADMA, in plasma, is significantly elevated in patients with renal disease and associated with cardiovascular morbidity and mortality. We found that whole blood (WB) possesses the metabolic pathways required for both the generation and elimination of ADMA and we have deve...
What is the current status of trial NCT00350974?
This trial is currently completed. The enrollment target is 61 participants. The study started on 2006-07. Estimated completion is 2007-03-08.
Who is sponsoring clinical trial NCT00350974?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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