Effect Of Paricalcitol (Zemplar) On Endothelial Function And Inflammation In Type 2 Diabetes And Chronic Kidney Disease
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ClinicalTrials.gov Identifier: NCT01792206 |
Recruitment Status
: Unknown
Verified February 2013 by Vasudevan Raghavan, Scott and White Hospital & Clinic.
Recruitment status was: Active, not recruiting
First Posted
: February 15, 2013
Last Update Posted
: February 15, 2013
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Tracking Information | |||
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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 |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | No Changes Posted | ||
Current Secondary Outcome Measures ICMJE |
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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. |
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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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Unknown status | ||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |