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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Vasudevan Raghavan, Scott and White Hospital & Clinic
ClinicalTrials.gov Identifier:
NCT01792206
First received: February 29, 2012
Last updated: February 12, 2013
Last verified: February 2013

February 29, 2012
February 12, 2013
September 2009
November 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01792206 on ClinicalTrials.gov Archive Site
  • Biomarker Measurement [ Time Frame: Baseline, 4 weeks, and 12 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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.

Same as current
Not Provided
Not Provided
 
Effect Of Paricalcitol (Zemplar) On Endothelial Function And Inflammation In Type 2 Diabetes And Chronic Kidney Disease
EFFECT OF PARICALCITOL (ZEMPLAR) ON ENDOTHELIAL FUNCTION AND INFLAMMATION IN TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
  • Type 2 Diabetes
  • Chronic Kidney Disease
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
February 2013
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01792206
81890
No
Vasudevan Raghavan, Scott and White Hospital & Clinic
Scott and White Hospital & Clinic
Abbott
Not Provided
Scott and White Hospital & Clinic
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP