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

• Sponsor: Scott and White Hospital & Clinic (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01792206
• Collaborator: Abbott (Industry)
• Enrollment: 60
• Locations: 4
• Arms: 2
• Duration (Months): 41
• Patients Per Site: 15
• Patients Per Site Per Month: 0.4

Study Details

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	Phase
Type 2 Diabetes; Chronic Kidney Disease	Drug: Zemplar; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• 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: Sep 1, 2009
• Actual Primary Completion Date: Nov 1, 2012
• Anticipated Study Completion Date: Feb 1, 2013

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. [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Emory University	Atlanta	Georgia	United States	30303
2	Tulane University	New Orleans	Louisiana	United States	70112
3	Joslin Diabetes Clinic, Inc.	Boston	Massachusetts	United States	02215
4	Omaha VA Medical Center	Omaha	Nebraska	United States	68105

Sponsors and Collaborators

• Scott and White Hospital & Clinic
• Abbott

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vasudevan Raghavan, Director, CArdioMEtabolic, Lipid Clinic and Medical Weight Management Program Services, Scott and White Hospital & Clinic
• ClinicalTrials.gov Identifier: NCT01792206
• Other Study ID Numbers: 81890
• First Posted: Feb 15, 2013
• Last Update Posted: Feb 15, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by Vasudevan Raghavan, Director, CArdioMEtabolic, Lipid Clinic and Medical Weight Management Program Services, Scott and White Hospital & Clinic: Stage 3 chronic kidney disease (CKD); Stage 4 chronic kidney disease (CKD); CKD
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 2; Inflammation

Study Results

No Results Posted as of Feb 15, 2013