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NCT00368017 · ClinicalTrials.gov registry record · Phase 2
Metabolic Effects of Thiazolidinediones in Chronic Kidney Disease
A Phase 2 study, sponsored by Vanderbilt University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT00368017 is a Phase 2 study that was terminated before completion, run by Vanderbilt University. The registered enrollment target is 12 participants.
The verdict
NCT00368017, a Phase 2 study, was terminated before completion, sponsored by Vanderbilt University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
The substantially increased cardiovascular morbidity and mortality rates in chronic kidney disease (CKD) patients cannot be sufficiently explained by traditional coronary risk factors. It is apparent that inflammation of the vessel wall plays an essential role in the pathophysiology of atherosclerosis, and the strong association between elevated inflammatory biomarkers and cardiovascular death further supports this mechanism. Approximately 50% of the mortality in this population of patients is attributable to cardiovascular disease. Insulin resistance is also a common problem in uremic patients. It has been shown that insulin resistance may contribute to atherosclerotic cardiovascular disease. An intriguing observation in CKD patients with advanced uremia is that the metabolic profile of these patients is characterized by persistent low-grade inflammation, a state of insulin resistance, and significantly increased prevalence of atherosclerosis. It is possible that these metabolic derangements can be the inciting factors for development and progression of uremic atherosclerosis. Peroxisome proliferator-activated receptor gamma (PPAR-gamma) is a ligand-activated nuclear transcription factor found in cells of the immune system and the vasculature, where it exerts an overall protective effect on the development of atherosclerosis, in part through modulation of inflammation. The agonists for PPAR-gamma improve not only the insulin resistance, but also have profound beneficial effects on inflammation, oxidative stress, endothelium, and lipid metabolism. In this proposal, the investigators hypothesize that short-term administration of a PPAR-gamma agonist (pioglitazone) will improve the inflammatory state, insulin resistance, and endothelial dysfunction in chronic kidney disease patients with advanced uremia.
Interventions
- DRUG placebo
- DRUG pioglitazone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2006-04 |
| Est. Completion | 2007-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00368017
The ClinicalTrials.gov registry entry for NCT00368017 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00368017 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00368017 about?
NCT00368017 is a clinical study titled "Metabolic Effects of Thiazolidinediones in Chronic Kidney Disease". The substantially increased cardiovascular morbidity and mortality rates in chronic kidney disease (CKD) patients cannot be sufficiently explained by traditional coronary risk factors. It is apparent that inflammation of the vessel wall plays an essential role in the pathophysiology of atheroscleros...
What is the current status of trial NCT00368017?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2006-04. Estimated completion is 2007-09.
What interventions are being tested in trial NCT00368017?
The interventions under investigation include: placebo (DRUG), pioglitazone (DRUG).
Who is sponsoring clinical trial NCT00368017?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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