Effect Of Paricalcitol (Zemplar) On Endothelial Function And Inflammation In Type 2 Diabetes And Chronic Kidney Disease
NCT ID: NCT01792206
Last Updated: 2013-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2009-09-30
2013-02-28
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
TRIPLE
Study Groups
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Zemplar
Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months
Zemplar
Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months
Placebo
Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months
Placebo
Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months
Interventions
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Zemplar
Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months
Placebo
Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months
Eligibility Criteria
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Inclusion Criteria
2. Age 18 - 70 years
3. 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
2. Congestive heart failure.
3. Inability to give informed consent or attend study related visits.
4. Have a history of abnormally high vitamin D or calcium levels in the bloodstream.
5. Unwilling or unable to complete screening or data collection procedures.
6. Have a known allergy to the study drug.
7. Pregnant or breast feeding
8. Plasma Calcium \>9 mg/dl
9. Patients should discontinue any calcium supplementation prior to entry into the study.
10. Other vitamin D analogs (eg Sensipar) and vitamin D preparations are contraindicated
18 Years
70 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Scott and White Hospital & Clinic
OTHER
Responsible Party
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Vasudevan Raghavan
Director, CArdioMEtabolic, Lipid Clinic and Medical Weight Management Program Services
Locations
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Emory University
Atlanta, Georgia, United States
Tulane University
New Orleans, Louisiana, United States
Joslin Diabetes Clinic, Inc.
Boston, Massachusetts, United States
Omaha VA Medical Center
Omaha, Nebraska, United States
Countries
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Other Identifiers
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81890
Identifier Type: -
Identifier Source: org_study_id
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