| Trial ID: | L0893 |
| Source ID: | NCT01792206
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| Associated Drug: |
Zemplar
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| Title: |
Effect Of Paricalcitol (Zemplar) On Endothelial Function And Inflammation In Type 2 Diabetes And Chronic Kidney Disease
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| Acronym: |
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| Status: |
UNKNOWN
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Type 2 Diabetes|Chronic Kidney Disease
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| Interventions: |
DRUG: Zemplar|DRUG: Placebo
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| Outcome Measures: |
Primary: The change in brachial artery Flow Mediated Dilataion with paracalcitol (1mcg/day)compared with placebo for 3 months., We therefore propose a study of the effects of Zemplar compared to placebo in patients with diabetes and stage 3-4 CKD on endothelial function and markers of inflammation and oxidative stress. The finding will help not only guide and encourage such treatment in similar patients, but will give us fundamental mechanistic insights into the role of vitamin D in the pathogenesis of diabetes and CVD., Baseline, 4 weeks, and 12 weeks | Secondary: Biomarker Measurement, Determine the prevalance of abnormalities in biomarkers of inflammation, oxidative stress and endothelial function in patients with CKD compared to a healthy population The following are the biomarkers of inflammation and oxidative stress to be measured in the secondary outcomes are: NFkB binding by mononuclear cells (MNC) ; ROS generation and p47phox expression by MNC plasma concentration of MMP-9, MCP-1, ICAM-1, IL-6 , CRP, ADMA and nitrotyrosine.. urinary isoprostane and plasma Nitrotyrosine in patients with CKD., Baseline, 4 weeks, and 12 weeks|Biomarker Measurement, Compare the change in biomarkers of inflammation, oxidative stress and endothelial function with paracalcitol (1mcg/day) compared with placebo for 3 months in patients with CKD. The following are the biomarkers of inflammation and oxidative stress to be measured in the secondary outcomes are: NFkB binding by mononuclear cells (MNC) ; ROS generation and p47phox expression by MNC plasma concentration of MMP-9, MCP-1, ICAM-1, IL-6 , CRP, ADMA and nitrotyrosine.. urinary isoprostane and plasma Nitrotyrosine in patients with CKD., Baseline, 4 weeks, and 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Scott and White Hospital & Clinic | Collaborators: Abbott
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
|
| Enrollment: |
60
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: DIAGNOSTIC
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| Start Date: |
2009-09
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| Completion Date: |
2013-02
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| Results First Posted: |
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| Last Update Posted: |
2013-02-15
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| Locations: |
Emory University, Atlanta, Georgia, 30303, United States|Tulane University, New Orleans, Louisiana, 70112, United States|Joslin Diabetes Clinic, Inc., Boston, Massachusetts, 02215, United States|Omaha VA Medical Center, Omaha, Nebraska, 68105, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01792206
|
