Effect Of Paricalcitol (Zemplar) On Endothelial Function And Inflammation In Type 2 Diabetes And Chronic Kidney Disease

Tracking Information
First Submitted Date ICMJE	February 29, 2012
First Posted Date ICMJE	February 15, 2013
Last Update Posted Date	February 15, 2013
Study Start Date ICMJE	September 2009
Actual Primary Completion Date	November 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 12, 2013)	The change in brachial artery Flow Mediated Dilataion with paracalcitol (1mcg/day)compared with placebo for 3 months. [ Time Frame: Baseline, 4 weeks, and 12 weeks ]; 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.
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: February 12, 2013)	Biomarker Measurement [ Time Frame: Baseline, 4 weeks, and 12 weeks ]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.; Biomarker Measurement [ Time Frame: Baseline, 4 weeks, and 12 weeks ]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.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Effect Of Paricalcitol (Zemplar) On Endothelial Function And Inflammation In Type 2 Diabetes And Chronic Kidney Disease
Official Title ICMJE	EFFECT OF PARICALCITOL (ZEMPLAR) ON ENDOTHELIAL FUNCTION AND INFLAMMATION IN TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Diagnostic
Condition ICMJE	Type 2 Diabetes; Chronic Kidney Disease
Intervention ICMJE	Drug: Zemplar Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months; Drug: Placebo Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months
Study Arms	Active Comparator: Zemplar Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months Intervention: Drug: Zemplar; Placebo Comparator: Placebo Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Actual Enrollment ICMJE; (submitted: February 12, 2013)	60
Original Actual Enrollment ICMJE	Same as current
Estimated Study Completion Date	February 2013
Actual Primary Completion Date	November 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Patients with Type 2 diabetes and CKD; Age 18 - 70 years; Stable anti-hypertensive and lipid lowering therapy for at least 2 months. All patients should be on an ACEI or ARB unless contraindicated because of side effects (standard of care). No changes in lipid lowering therapy during the 3 months of this study. Blood pressure doses may be changed but new therapy with ACE inhibitors will not be allowed. Exclusion Criteria: Severe co morbid conditions - e.g. Cancer, etc.; Congestive heart failure.; Inability to give informed consent or attend study related visits.; Have a history of abnormally high vitamin D or calcium levels in the bloodstream.; Unwilling or unable to complete screening or data collection procedures.; Have a known allergy to the study drug.; Pregnant or breast feeding; Plasma Calcium >9 mg/dl; Patients should discontinue any calcium supplementation prior to entry into the study.; Other vitamin D analogs (eg Sensipar) and vitamin D preparations are contraindicated
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 70 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01792206
Other Study ID Numbers ICMJE	81890
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Vasudevan Raghavan, Scott and White Hospital & Clinic
Study Sponsor ICMJE	Scott and White Hospital & Clinic
Collaborators ICMJE	Abbott
Investigators ICMJE	Not Provided
PRS Account	Scott and White Hospital & Clinic
Verification Date	February 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP