search
Back to results

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

Primary Purpose

Type 2 Diabetes, Chronic Kidney Disease

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zemplar
Placebo
Sponsored by
Scott and White Hospital & Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Type 2 Diabetes focused on measuring Stage 3 chronic kidney disease (CKD), Stage 4 chronic kidney disease (CKD), CKD

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory University
  • Tulane University
  • Joslin Diabetes Clinic, Inc.
  • Omaha VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Zemplar

Placebo

Arm Description

Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months

Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months

Outcomes

Primary Outcome Measures

The change in brachial artery Flow Mediated Dilataion with paracalcitol (1mcg/day)compared with placebo for 3 months.
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

Biomarker Measurement
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
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.

Full Information

First Posted
February 29, 2012
Last Updated
February 12, 2013
Sponsor
Scott and White Hospital & Clinic
Collaborators
Abbott
search

1. Study Identification

Unique Protocol Identification Number
NCT01792206
Brief Title
Effect Of Paricalcitol (Zemplar) On Endothelial Function And Inflammation In Type 2 Diabetes And Chronic Kidney Disease
Official Title
EFFECT OF PARICALCITOL (ZEMPLAR) ON ENDOTHELIAL FUNCTION AND INFLAMMATION IN TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
February 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scott and White Hospital & Clinic
Collaborators
Abbott

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Chronic Kidney Disease
Keywords
Stage 3 chronic kidney disease (CKD), Stage 4 chronic kidney disease (CKD), CKD

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zemplar
Arm Type
Active Comparator
Arm Description
Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months
Intervention Type
Drug
Intervention Name(s)
Zemplar
Intervention Description
Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months
Primary Outcome Measure Information:
Title
The change in brachial artery Flow Mediated Dilataion with paracalcitol (1mcg/day)compared with placebo for 3 months.
Description
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.
Time Frame
Baseline, 4 weeks, and 12 weeks
Secondary Outcome Measure Information:
Title
Biomarker Measurement
Description
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.
Time Frame
Baseline, 4 weeks, and 12 weeks
Title
Biomarker Measurement
Description
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.
Time Frame
Baseline, 4 weeks, and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Joslin Diabetes Clinic, Inc.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Omaha VA Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs