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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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The purpose of this research study is to study the effects of paricalcitol on endothelial function and inflammation, cardiovascular risk factors which are associated with patient populations that have Type 2 diabetes and Stage 3 and 4 Chronic Kidney Disease (CKD).
Hypothesis 1: The state of CKD is associated with oxidative stress and inflammation and impaired post ischemic endothelium dependent flow mediated vasodilation which may contribute to atherogenesis.
Hypothesis 2: The administration of paracalcitol to patients with CKD will suppress oxidative stress and inflammation and improve endothelial function and thus contribute to an anti-atherogenic action.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zemplar | Active Comparator | Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months |
|
| Placebo | Placebo Comparator | Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zemplar | Drug | Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30303 | United States | ||
| Tulane University |
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| Placebo |
| Drug |
Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months |
|
| 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 |
| New Orleans |
| Louisiana |
| 70112 |
| United States |
| Joslin Diabetes Clinic, Inc. | Boston | Massachusetts | 02215 | United States |
| Omaha VA Medical Center | Omaha | Nebraska | 68105 | United States |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C084656 | paricalcitol |
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