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Sponsored by: |
Vanderbilt University |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00368017 |
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.
Condition | Intervention | Phase |
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Chronic Kidney Disease |
Drug: pioglitazone Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Metabolic Effects of Thiazolidinediones in Chronic Kidney Disease |
Estimated Enrollment: | 84 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: pioglitazone
30 mg once a day for 12 weeks
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2: Placebo Comparator |
Drug: placebo
1 pill once a day for 12 weeks
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Alp Ikizler, MD | Vanderbilt University |
Responsible Party: | Vanderbilt University Medical Center ( Alp Ikizler, MD ) |
Study ID Numbers: | 060042 |
Study First Received: | August 23, 2006 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00368017 History of Changes |
Health Authority: | United States: Institutional Review Board |
Renal Insufficiency Hypoglycemic Agents Pioglitazone Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic 2,4-thiazolidinedione Kidney Diseases Kidney Failure |
Renal Insufficiency Hypoglycemic Agents Pioglitazone Urologic Diseases Renal Insufficiency, Chronic Physiological Effects of Drugs |
Kidney Failure, Chronic 2,4-thiazolidinedione Kidney Diseases Pharmacologic Actions Kidney Failure |