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

Type 2 Diabetes Clinical Trial

Official title:

EFFECT OF PARICALCITOL (ZEMPLAR) ON ENDOTHELIAL FUNCTION AND INFLAMMATION IN TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01792206
• Other study ID #: 81890
• Status: Active, not recruiting
• Phase: N/A
• First received: February 29, 2012
• Last updated: February 12, 2013
• Start date: September 2009
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: Scott and White Hospital & Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: February 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic
• Type 2 Diabetes

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Joslin Diabetes Clinic, Inc.	Boston	Massachusetts
United States	Tulane University	New Orleans	Louisiana
United States	Omaha VA Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Scott and White Hospital & Clinic	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 4 weeks, and 12 weeks	No
Secondary	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.	Baseline, 4 weeks, and 12 weeks	No
Secondary	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.	Baseline, 4 weeks, and 12 weeks	No