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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Type 2 Diabetes Chronic Kidney Disease Drug: Zemplar Drug: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: EFFECT OF PARICALCITOL (ZEMPLAR) ON ENDOTHELIAL FUNCTION AND INFLAMMATION IN TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE
Study Start Date : September 2009
Primary Completion Date : November 2012
Estimated Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Zemplar
Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months
Drug: Zemplar
Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months
Placebo Comparator: Placebo
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.



Eligibility Criteria

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with Type 2 diabetes and CKD
  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:

  1. Severe co morbid conditions - e.g. Cancer, etc.
  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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792206


Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30303
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Joslin Diabetes Clinic, Inc.
Boston, Massachusetts, United States, 02215
United States, Nebraska
Omaha VA Medical Center
Omaha, Nebraska, United States, 68105
Sponsors and Collaborators
Scott and White Hospital & Clinic
Abbott
More Information

Responsible Party: Vasudevan Raghavan, Director, CArdioMEtabolic, Lipid Clinic and Medical Weight Management Program Services, Scott and White Hospital & Clinic
ClinicalTrials.gov Identifier: NCT01792206     History of Changes
Other Study ID Numbers: 81890
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013

Keywords provided by Vasudevan Raghavan, Scott and White Hospital & Clinic:
Stage 3 chronic kidney disease (CKD)
Stage 4 chronic kidney disease (CKD)
CKD

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Inflammation
Kidney Diseases
Renal Insufficiency, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Urologic Diseases
Renal Insufficiency
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents