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

Not Applicable

• Conditions: Type 2 Diabetes; Chronic Kidney Disease
• Interventions: Drug: Placebo; Drug: Zemplar

• Registration Number: NCT01792206
• Lead Sponsor: Scott and White Hospital & Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2012-02-29
• Primary Completion: 2012-11
• Status Verified: 2013-02
• Study Completion: 2013-02
• Study First Submitted QC: 2013-02-12
• Last Update Submitted: 2013-02-12
• Study First Posted: 2013-02-15
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months
Zemplar	Zemplar	Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months

Primary Outcome Measures

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

Name	Time	Method
Biomarker Measurement	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.

Trial Locations

Locations (4)

Tulane University; 🇺🇸 New Orleans, Louisiana, United States

Omaha VA Medical Center; 🇺🇸 Omaha, Nebraska, United States

Joslin Diabetes Clinic, Inc.; 🇺🇸 Boston, Massachusetts, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States